Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel

NCT03851848 | Unknown

• 1 other identifier: plantar heel pain
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Plantar Fasciitis

Keywords

Myofascial release; Ankle and foot mobilization; Diabetic patients; plantar heel pain

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

  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.

  the change after 5 minutes of treatment and the change after 2 weeks of treatment .

Secondary Outcomes (4)

• 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 .

Study Arms (2)

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.

Other: Joint mobilization (JM)

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 .

Other: Myofascial release (MFR)

Interventions

Joint mobilization (JM) OTHER

Joint mobilization (JM) is a manual therapy to move the joint in a desired direction. It is commonly used for improving the joints' ROM and pain intensity, and to overcome joint restriction.

Joint mobilization (JM) group

Myofascial release (MFR) OTHER

Myofascial release (MFR) is a technique in which a slow, sustained pressure is applied to the restricted soft tissue in order to restore optimal length, reduce pain and improve function.

Myofascial release (MFR) group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Security Forces hospital

Riyadh, Saudi Arabia

RECRUITING

Related Publications (4)

• 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.

  PMID: 26400901 BACKGROUND

• 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.

  PMID: 24703512 BACKGROUND

• 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.

  PMID: 24139003 BACKGROUND

• 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.

  PMID: 21285525 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Fasciitis, Plantar

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Deanship of Graduate Studies

CONTACT

+9661333 32562; gs@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 22, 2019
• Study Start: March 3, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

SA (1)