Clinical trial NCT03851848: Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
Official title: Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Plantar Fasciitis
Keywords: Myofascial release
Ankle and foot mobilization
Diabetic patients
plantar heel pain
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes mellitus (DM) increases stiffness and thickness of foot structures. This may alter the foot's biomechanics and increase plantar pressure distribution, mainly on the forefoot region. Presence of plantar heel pain (PHP) also may alter the foot's rollover mechanism and increase plantar loading in the forefoot as a protective mechanism of pain. The risk of diabetic ulcer formation increases with these restricted ankle range of motion (ROM) and increased foot plantar pressure that may present in DM patient with PHP.

The association that has been established previously between limited ankle ROM and PHP leads to a reasonable utilization of joint and soft tissue mobilization in treating diabetic patients with PHP. The aim of this study is to investigate the immediate and short-term effect of a single session of ankle and foot joint mobilization (JM) versus Myofascial release (MFR) on pain intensity, ankle ROM, foot plantar pressure, dynamic and static balance, and functional level of diabetic patients with PHP.

The findings of this study will help to understand the effect of these two interventions on diabetic patients with PHP in term of the previously mentioned parameters. This may guide the physiotherapists to choose the best available technique to treat DM patients with PHP, and that may help to reduce the risk of DM foot complications.

Detailed description: It is a clinical experimental study of 46 controlled diabetic patients (type II) above 30 years with unilateral PHP who will present to physiotherapy screening clinic through the medical referral. The participants will be evaluated then distributed randomly to receive a single session of either JM or MFR followed by an immediate reassessment and a follow-up reassessment after 2 weeks. The assessment will include ankle ROM, pain intensity (visual analog scale), static balance (one leg stance test), dynamic balance (time up and go test), plantar pressure distribution, and functional level (lower extremity functional scale LEFS). Analysis of parametric data will be done using ANOVA for the repeated measure. LEFS score will be calculated using Mann-Whitney U test for nonparametric data. Alpha \< 0.05.

Eligibility criteria: Inclusion Criteria:

1. Controlled diabetic patients (type II)
2. aged above 30 years
3. presented with unilateral plantar heel pain that diagnosed based on the following criteria (pain located at the heel or plantar surface of the mid-foot, morning first steps pain, and increased pain on weight bearing after a period of rest ).

Exclusion Criteria:

1. ankle or foot deformity.
2. corticosteroids injection in the heel in the past 3 months.
3. neurological disorders, nerve entrapment in lower extremities or peripheral neuropathy (by 10-g monofilament and tuning fork of 128 Hz testing based on American Diabetes Association recommendations.
4. red flags to either the joints mobilization (JM) : (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, severe vascular disease, prolonged steroid use) or the myofascial release (MFR) (e.g. infective conditions) .

Primary outcomes:
measure: Pain intensity level will be measured using visual analog scale (VAS)
timeFrame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
measure: Talocrural joint dorsiflexion ROM will be measured using a universal goniometer
timeFrame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Secondary outcomes:
measure: Functional level will be measured using Lower extremity functional scale (LEFS)
timeFrame: after 2 weeks of treatment .
measure: Static balance will be measured using One leg stance test (OLS)
timeFrame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
measure: Dynamic balance will be measured using Time up and go test (TUG)
timeFrame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
measure: Foot plantar pressure distribution (FPP) will be measured using Platform Pedography system
timeFrame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces hospital
Study officials:
References:
citation: Celik D, Kus G, Sirma SO. Joint Mobilization and Stretching Exercise vs Steroid Injection in the Treatment of Plantar Fasciitis: A Randomized Controlled Study. Foot Ankle Int. 2016 Feb;37(2):150-6. doi: 10.1177/1071100715607619. Epub 2015 Sep 23.
citation: Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
citation: Grieve R, Cranston A, Henderson A, John R, Malone G, Mayall C. The immediate effect of triceps surae myofascial trigger point therapy on restricted active ankle joint dorsiflexion in recreational runners: a crossover randomised controlled trial. J Bodyw Mov Ther. 2013 Oct;17(4):453-61. doi: 10.1016/j.jbmt.2013.02.001. Epub 2013 Apr 21.
citation: Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.