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Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel

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ClinicalTrials.gov Identifier: NCT03851848
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Afnan Alabdulaaly, Imam Abdulrahman Bin Faisal University

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE February 22, 2019
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE March 3, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03851848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Functional level will be measured using Lower extremity functional scale (LEFS) [ Time Frame: after 2 weeks of treatment . ]
    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) [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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) [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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 [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Lower extremity functional scale (LEFS) [ Time Frame: after 2 weeks of treatment . ]
    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).
  • One leg stance test (OLS) [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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 up and go test (TUG) [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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
  • Platform Pedography system [ Time Frame: the change after 5 minutes of treatment and the change after 2 weeks of treatment . ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
Official Title  ICMJE Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot
  • Plantar Fasciitis
Intervention  ICMJE
  • Other: 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: 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.
Study Arms  ICMJE
  • Experimental: Joint mobilization (JM) group
    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: Other: Joint mobilization (JM)
  • Experimental: Myofascial release (MFR) group
    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: Other: Myofascial release (MFR)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2019)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deanship of Graduate Studies +9661333 32562 ext 32562 gs@iau.edu.sa
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03851848
Other Study ID Numbers  ICMJE plantar heel pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Afnan Alabdulaaly, Imam Abdulrahman Bin Faisal University
Study Sponsor  ICMJE Imam Abdulrahman Bin Faisal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Imam Abdulrahman Bin Faisal University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP