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Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel

Primary Purpose

Diabetic Foot, Plantar Fasciitis

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Joint mobilization (JM)
Myofascial release (MFR)
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Myofascial release, Ankle and foot mobilization, Diabetic patients, plantar heel pain

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) .

Sites / Locations

  • Security Forces hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Joint mobilization (JM) group

Myofascial release (MFR) group

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Functional level will be measured using Lower extremity functional scale (LEFS)
The participants' functional level will be measured using the Arabic version of LEFS. The scale is a self-report outcome measure that was established to assess the limitation of functional activity due to lower extremity musculoskeletal disorders. It consists of 20 questions, and each question is scored from zero (maximum difficulty or inability to perform the activity) to four (no difficulty). The maximum score is eighty, which represents the highest functional level. The minimal clinically important difference (MCID) is nine points. It is a valid tool and has excellent test-retest reliability in measuring activity limitation in patients with lower-extremity musculoskeletal disorders (that includes patient with plantar heel pain).
Static balance will be measured using One leg stance test (OLS)
The OLS test will be administered on the limb of PHP. The participant will stand on the affected side barefoot, both hands on the iliac crest and with both eyes closed. The patient's other leg will be slightly flexed off the ground. Verbal cue will be given to start the test; the participant will be asked to stand on the tested leg for as long as possible. The test will be finished either after completed 30 sec, or in these cases: when the standing foot moved or shifted, or when non-standing foot touch the ground . For the patient's safety, the therapist will be standing close to the patient throughout the test. .The test has a good Inter-rater reliability (ICC=0.75) and Inter-subject reliability (ICC=0.73)
Dynamic balance will be measured using Time up and go test (TUG)
The TUG test measures the ability of the participant to stand up from a standard armchair, walk for three meters, turn at a marked object and return back to the chair as fast as possible. The participant will receive a verbal command "go" to start the test. The timing will begin once the command is given and will stop once the patient return to the chair. To ensure the safety and prevent falls, the chair-back will be stabilized against the wall, the walking area will be free from obstacles, and the therapist will be close to the patient.The test has an excellent inter-rater (ICC=0.99) and test-retest (ICC=. 99) reliability
Foot plantar pressure distribution (FPP) will be measured using Platform Pedography system
Foot plantar pressure (FPP) will be evaluated using Platform Pedography system (EMED® system) . It consists of a platform that contains calibrated capacitive sensors and connected to the computer software operating system. The platform is inserted in the middle of a foamed walkway. The participant will be asked to stand barefoot on the platform with both arms held relaxed beside their trunk to assess the static foot pressure distribution. Then the patient will walk barefoot on the assessment-walking track with their regular speed and step length to evaluate the dynamic foot pressure distribution. The system is an accurate, valid and reliable tool for measuring static and dynamic foot pressure.

Full Information

First Posted
February 19, 2019
Last Updated
March 3, 2019
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT03851848
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Plantar Fasciitis
Keywords
Myofascial release, Ankle and foot mobilization, Diabetic patients, plantar heel pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Joint mobilization (JM) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Myofascial release (MFR) group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Joint mobilization (JM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release (MFR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity level will be measured using visual analog scale (VAS)
Description
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.
Time Frame
the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Title
Talocrural joint dorsiflexion ROM will be measured using a universal goniometer
Description
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.
Time Frame
the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Secondary Outcome Measure Information:
Title
Functional level will be measured using Lower extremity functional scale (LEFS)
Description
The participants' functional level will be measured using the Arabic version of LEFS. The scale is a self-report outcome measure that was established to assess the limitation of functional activity due to lower extremity musculoskeletal disorders. It consists of 20 questions, and each question is scored from zero (maximum difficulty or inability to perform the activity) to four (no difficulty). The maximum score is eighty, which represents the highest functional level. The minimal clinically important difference (MCID) is nine points. It is a valid tool and has excellent test-retest reliability in measuring activity limitation in patients with lower-extremity musculoskeletal disorders (that includes patient with plantar heel pain).
Time Frame
after 2 weeks of treatment .
Title
Static balance will be measured using One leg stance test (OLS)
Description
The OLS test will be administered on the limb of PHP. The participant will stand on the affected side barefoot, both hands on the iliac crest and with both eyes closed. The patient's other leg will be slightly flexed off the ground. Verbal cue will be given to start the test; the participant will be asked to stand on the tested leg for as long as possible. The test will be finished either after completed 30 sec, or in these cases: when the standing foot moved or shifted, or when non-standing foot touch the ground . For the patient's safety, the therapist will be standing close to the patient throughout the test. .The test has a good Inter-rater reliability (ICC=0.75) and Inter-subject reliability (ICC=0.73)
Time Frame
the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Title
Dynamic balance will be measured using Time up and go test (TUG)
Description
The TUG test measures the ability of the participant to stand up from a standard armchair, walk for three meters, turn at a marked object and return back to the chair as fast as possible. The participant will receive a verbal command "go" to start the test. The timing will begin once the command is given and will stop once the patient return to the chair. To ensure the safety and prevent falls, the chair-back will be stabilized against the wall, the walking area will be free from obstacles, and the therapist will be close to the patient.The test has an excellent inter-rater (ICC=0.99) and test-retest (ICC=. 99) reliability
Time Frame
the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Title
Foot plantar pressure distribution (FPP) will be measured using Platform Pedography system
Description
Foot plantar pressure (FPP) will be evaluated using Platform Pedography system (EMED® system) . It consists of a platform that contains calibrated capacitive sensors and connected to the computer software operating system. The platform is inserted in the middle of a foamed walkway. The participant will be asked to stand barefoot on the platform with both arms held relaxed beside their trunk to assess the static foot pressure distribution. Then the patient will walk barefoot on the assessment-walking track with their regular speed and step length to evaluate the dynamic foot pressure distribution. The system is an accurate, valid and reliable tool for measuring static and dynamic foot pressure.
Time Frame
the change after 5 minutes of treatment and the change after 2 weeks of treatment .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deanship of Graduate Studies
Phone
+9661333 32562
Ext
32562
Email
gs@iau.edu.sa
Facility Information:
Facility Name
Security Forces hospital
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afnan A Alabdulaaly, M.Sc
Phone
+996576487789
Email
PT.afnan@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26400901
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.
Results Reference
background
PubMed Identifier
24703512
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.
Results Reference
background
PubMed Identifier
24139003
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.
Results Reference
background
PubMed Identifier
21285525
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.
Results Reference
background

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Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel

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