Clinical trial NCT01196949: Comparing Manipulation and Rehabilitation to Rehabilitation Only, in the Management of Chronic Ankle Instability
Official title: The Effectiveness of Combined Manipulation and Rehabilitation Versus Rehabilitation Only, in the Management of Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ankle Instability
Keywords: Ankle
Chronic
Instability
Manipulative
Rehabilitative
Manipulation
Rehabilitation
Lead sponsor: Cleveland Chiropractic College
Sponsor class: OTHER
Collaborators: name: Durban University of Technology
First posted: 2010-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is hypothesized that a combination approach would produce increased clinically and statistically significant outcomes as opposed to standard single intervention, inclusive of comparatively greater reduction in pain, improvement in range of motion, proprioception and function with an associated quicker recovery time.

Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal system. Various individual treatment options have previously been compared to one another in clinical trials, however there is paucity of literature with regards to combined treatment choices versus individual therapy. The purpose of this study is to investigate the relative effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the management of CAI.

The study will be conducted as a single blinded randomised and comparative clinical trial at Cleveland Chiropractic College and Durban University of Technology.

Detailed description: Rationale

1. Inversion ankle sprains are the most frequently encountered injury to the ankle (Ferran and Maffulli, 2006) especially in the realm of the sporting arena (Balint et al, 2003; Delahunt, 2007; Bozzelle and Kishner, 2008). Up to 40 % of these acutely injured participants will progress to a state of chronic ankle instability (CAI) (Verhagen et al, 1995; Balint et al, 2003; Ajis and Maffulli, 2006; Ajis et al, 2006). Therefore the lateral ankle as well as the management of CAI requires further investigation with regard to treatment options.
2. Peroneal muscle weaknesses as well as proprioceptive deficits have been universally encountered in cases of CAI (Reid, 1992; Delahunt, 2007). Studies have indicated that coupled peroneal muscle strengthening and proprioception training of the ankle are seen as the most efficient means of rehabilitation for CAI (Reid, 1992; Ajis et al, 2006; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007; Lee and Lin, 2008). Pellow and Brantingham, (2001) and Gillman, (2004) have reported that manipulation is also a successful intervention tool for the treatment of CAI, documenting a statistically significant reduction in pain (p=0.007), improved range of motion (p=0.199) in the ankle joint as well as improved general functioning of the ankle (p=0.004). It has been identified that there are three components (Richie, 2001; Sefton et al, 2008) that contribute to the persistence of CAI namely joint fixations (in the mortise and subtalar joint) as well as muscular (Richie, 2001) and proprioceptive alterations (Richie, 2001; Delahunt, 2007).
3. It is hypothesised that a combination approach would produce increased clinically and statistically significant outcomes as opposed to standard single intervention, inclusive of comparatively greater reduction in pain, improvement in range of motion, proprioception and function with an associated quicker recovery time (Green et al, 2001; Eisenhart et al, 2003; Collins,2004; Vicenzino et al, 2006). There are insufficient studies, particularly high quality studies, with the required methodology, to make a definitive decision regarding whether this is supported (Van der Wees et al, 2006; Whitman et al, 2009). Additionally chiropractors will typically manage a participant with CAI with a combination of manipulation and rehabilitation, at present no research using such combined therapy by chiropractors has yet been published (Brantingham et al, 2009).

3. Research Problem and Aims The aim of the study is to investigate the relative effectiveness of a combination of manipulation and rehabilitation as compared to rehabilitation only in the treatment for CAI, in terms of participantive and objective clinical assessments.

The specific objectives of the study are:

1. To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of objective assessments (algometer, berg balance scale, weight bearing ankle dorsiflexion test and foot and ankle disability index in participants experiencing CAI syndrome).
2. To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of participantive assessments (visual analogue scale and motion palpation) in participants experiencing CAI syndrome.

Eligibility criteria: Inclusion Criteria:

1. Participants with grade one (Grade I: evidence of minimal swelling with minimal dysfunction, point tenderness over joint, absence of positive anterior drawers sign) or grade two (Grade II: moderate amount of swelling and haemorrhage over the ankle with pain more do on weight bearing). Potentially positive anterior drawers sign but with no varus laxity CLAI (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).
2. Participants between the ages of 18 - 45 years (Pellow and Brantingham, 2001; Chowdry et al, 2003; Parker, 2005).
3. Participants that are clinically diagnosed as having CLAI: the presence of 4 or more of a combination of symptoms including lateral ankle pain, joint weakness, oedema (Tatro-Adams et al, 1995), joint crepitus, adhesions resulting in the formation of fixations in the joint and ligamentous laxity (Reid, 1992; Pellow and Brantingham, 2001; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007).
4. Participants with a visual analogue scale (vas) (Liggins, 1982; Salaffi et al, 2003) score of between 20 and 70 millimetres to maintain homogeneity within the sample (Mouton, 1996).
5. Participants with a foot/ankle disability Index (FADI) (Hale and Hertel, 2005) of between 50 and 90 to maintain homogeneity within the sample (Mouton, 1996).
6. Participants with a berg balance scale (Kornetti et al, 2004) of less than 45/56 to maintain homogeneity within the sample (Mouton, 1996).
7. Participants must have the presence of fixations in either the mortise joint, the subtalar joint or the tarsals (Brantingham et al, 2007).
8. Participants that give informed consent to participate in the research.
9. Participants on muscle relaxants or any anti inflammatory medication will be required to have a wash out period of three days before participating in the study (Poul et al, 1993; Seth, 1999).

Exclusion Criteria:

1. Participants who have experienced an acute injury or acute re-injury (prior to or during the study) will be excluded from the study because it does not comply with the six-week interval (i.e. chronic injuries) (Pellow and Brantingham, 2001).
2. Participants with balance disorders of a neurological and/or otological and/or vascular cause of dizziness that may mimic instability and defective proprioception at the ankle level (Clark and Burden, 2005; Kynsberg et al, 2006).
3. Participants with connective tissue disorders that create excessive generalised ligamentous laxity, participants with these conditions will not benefit from the treatment with generalised hyper laxity of ligaments.
4. Participants with grade three CAI/ gross mechanical instability of the lateral ankle complex as the severity of this grade of injury usually requires surgical intervention and is unresponsive to conservative therapy (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).Grade III: severe swelling and haemorrhage with positive anterior drawers sign and rupture of ligamentous structures.
5. Participants that are contraindicated to adjustments, which include but may not be limited to (Kirkaldy - Willis and Burton, 1992).

Absolute contraindications, Destructive injury of the skeletal structures of the body; fractures and dislocations of all varieties; neurological damage as in Cauda equina syndrome, abdominal aortic aneurysm, referred pain of a visceral nature.

Relative Contraindications, bone demineralization, psychosomatic conditions, anticoagulant therapy and/or conditions where hemorrhaging may be present and Spondyloarthropathies.

Participants with secondary manifestations of any of the following conditions, which may compromise balance/ proprioception, which are contraindicated to rehabilitation, which include and may not be limited to (Frontera, 1999).

Dizziness that is present during the treatment Peripheral vascular disease

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 3months
Secondary outcomes:
measure: Foot Ankle Disability Index
timeFrame: 3 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Durban University of Technology
Study officials:
affiliation: Cleveland Chiropractic College
name: James W Brantingham, Dc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durban University of Technology
name: Danella Lubbe
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Balint GP, Korda J, Hangody L, Balint PV. Regional musculoskeletal conditions: foot and ankle disorders. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):87-111. doi: 10.1016/s1521-6942(02)00103-1.
citation: Delahunt, E. 2007. Neuromuscular contributions to functional instability of the ankle joint. Journal of Bodywork and Movement Therapies, 11:203-213.
citation: Bozzelle, J.R. and Kishner, S. Recurrent Ankle Sprains. [Online] Available: http://emedicine.com, [Accessed August 2009].
citation: Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.
citation: Reid, C.D. 1992. Sports Injury Assessment and Rehabilitation. United States of America: Churchill Livingston Inc
citation: McBride DJ, Ramamurthy C. Chronic ankle instability: management of chronic lateral ligamentous dysfunction and the varus tibiotalar joint. Foot Ankle Clin. 2006 Sep;11(3):607-23. doi: 10.1016/j.fcl.2006.07.009.
citation: Caulfield, B. 2000. Functional Instability of the Ankle Joint, features and underlying causes. Physiotherapy, 86:8
citation: Lee AJ, Lin WH. Twelve-week biomechanical ankle platform system training on postural stability and ankle proprioception in subjects with unilateral functional ankle instability. Clin Biomech (Bristol). 2008 Oct;23(8):1065-72. doi: 10.1016/j.clinbiomech.2008.04.013. Epub 2008 Jul 14.
citation: Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther. 2001 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.
citation: Green T, Refshauge K, Crosbie J, Adams R. A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains. Phys Ther. 2001 Apr;81(4):984-94.
citation: van der Wees PJ, Lenssen AF, Hendriks EJ, Stomp DJ, Dekker J, de Bie RA. Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review. Aust J Physiother. 2006;52(1):27-37. doi: 10.1016/s0004-9514(06)70059-9.
citation: Brantingham JW, Globe G, Pollard H, Hicks M, Korporaal C, Hoskins W. Manipulative therapy for lower extremity conditions: expansion of literature review. J Manipulative Physiol Ther. 2009 Jan;32(1):53-71. doi: 10.1016/j.jmpt.2008.09.013.