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Clinical Trials/NCT03851848
NCT03851848UnknownNot Applicable

Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel

Imam Abdulrahman Bin Faisal University1 site in 1 country46 target enrollmentStarted: March 3, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
46
Locations
1
Primary Endpoint
Talocrural joint dorsiflexion ROM will be measured using a universal goniometer

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Controlled diabetic patients (type II)
  • aged above 30 years
  • 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

  • ankle or foot deformity.
  • corticosteroids injection in the heel in the past 3 months.
  • 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.
  • 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) .

Arms & Interventions

Joint mobilization (JM) group

Experimental

The Maitland mobilization technique will target three main joints of the affected foot in order to facilitate major ankle and foot movements: (1) Talocrural joint Anterior-posterior (AP) mobilization will be performed to enhance ankle dorsiflexion ROM; (2) first metatarsal phalangeal joint (FMTP) AP glide will be performed to facilitate big toe extension ROM; (3) subtalar joint traction will be performed to increase both foot eversion and inversion ROM, and lateral glide will be performed to reinforce inversion ROM.

Intervention: Joint mobilization (JM) (Other)

Myofascial release (MFR) group

Experimental

The MFR technique will be performed as a direct trigger point release followed by deep soft tissue release for the calf muscles (gastrocnemius and soleus) and the plantar fascia .

Intervention: Myofascial release (MFR) (Other)

Outcomes

Primary Outcomes

Talocrural joint dorsiflexion ROM will be measured using a universal goniometer

Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .

Talocrural joint dorsiflexion ROM will be measured using a universal goniometer. The patient will be in a supine position, with his foot hanging over the edge of the bed. The goniometer fulcrum will be placed on the lateral malleoli, the stationary arm in line with the fibular head, and the movable arm on the lateral border of the foot toward the fifth metatarsal head. The participant will be asked to move the ankle actively from the neutral position as far as possible toward dorsiflexion. It is a valid tool in measuring joints ROM and has a good intra-rater reliability in measuring ankle dorsiflexion . The ROM score will be expressed in degree.

Pain intensity level will be measured using visual analog scale (VAS)

Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .

Pain level will be recorded using VAS. The VAS is a continuous and unidimensional scale that measures subjective pain intensity level. It is a line of 10 cm (100 mm) length, starting from zero, which indicates no pain, to ten that represents the maximum imaginable level of pain . The participants will be asked to record their current pain by drawing a perpendicular line to the VAS line at the point that reflects their pain level. The result will be scored by measuring the distance (mm) on 10-cm line between the zero and patient's mark using a ruler. For the scores interpretation, the higher scores indicate greater level of pain. VAS is a valid and reliable tool for measuring acute and chronic adult pain.

Secondary Outcomes

  • Functional level will be measured using Lower extremity functional scale (LEFS)(after 2 weeks of treatment .)
  • Static balance will be measured using One leg stance test (OLS)(the change after 5 minutes of treatment and the change after 2 weeks of treatment .)
  • Dynamic balance will be measured using Time up and go test (TUG)(the change after 5 minutes of treatment and the change after 2 weeks of treatment .)
  • Foot plantar pressure distribution (FPP) will be measured using Platform Pedography system(the change after 5 minutes of treatment and the change after 2 weeks of treatment .)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Afnan Alabdulaaly

Principal Investigator

Imam Abdulrahman Bin Faisal University

Study Sites (1)

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