Diabetic FootNCT03851848
Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
A study testing Joint mobilization (JM) and Myofascial release (MFR) in people with Diabetic Foot and Plantar Fasciitis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Foot, Plantar Fasciitis
- What is being tested?
- Joint mobilization (JM) and Myofascial release (MFR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Mar 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ).
Who cannot join
- 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) .
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Security Forces hospital
Riyadh
Afnan A Alabdulaaly, M.Sc, +996576487789, PT.afnan@gmail.com
About this study
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.
Read the 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.
- Conditions
- Diabetic Foot, Plantar Fasciitis
- Being tested
- Joint mobilization (JM), Myofascial release (MFR)
- Keywords
- Myofascial release, Ankle and foot mobilization, Diabetic patients, plantar heel pain
- Medical subject headings
- Diabetic Foot, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Other: Myofascial release (MFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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).
Measured: after 2 weeks of treatment .
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)
Measured: 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 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
Measured: 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
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.
Measured: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start3 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Alabdulaaly, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851848
- Sponsor's protocol ID
- plantar heel pain
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26400901Ajimsha 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.
PubMed 24703512Grieve 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.
PubMed 24139003Renan-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.
PubMed 21285525
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
- ClinicalTrials.gov ID
- NCT03851848
- Acronym / sponsor ID
- plantar heel pain
- Conditions
- Diabetic Foot, Plantar Fasciitis
- Keywords
- Myofascial release, Ankle and foot mobilization, Diabetic patients, plantar heel pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint mobilization (JM) group | Experimental | Other: Joint mobilization (JM)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. |
| Myofascial release (MFR) group | Experimental | Other: Myofascial release (MFR)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 . |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 ).
Key exclusion criteria (4 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint mobilization (JM)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. | Other | Joint mobilization (JM) group |
| Myofascial release (MFR)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. | Other | Myofascial release (MFR) group |
Primary outcome
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.
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.
4 secondary outcomes
Functional level will be measured using Lower extremity functional scale (LEFS)
Time frame: after 2 weeks of treatment .
Static balance will be measured using One leg stance test (OLS)
Time frame: 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)
Time frame: 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
Time frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Background: PubMed 26400901Celik 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.
- Background: PubMed 24703512Ajimsha 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.
- Background: PubMed 24139003Grieve 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.
- Background: PubMed 21285525Renan-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint mobilization (JM) and Myofascial release (MFR) in people with Diabetic Foot and Plantar Fasciitis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deanship of Graduate Studies (+9661333 32562 ext. 32562, gs@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851848, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.