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CTRI Number  CTRI/2024/11/076311 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Structural Diagnosis and Management Approach and Myofascial Release for Heel Pain in Diabetic Patients.  
Scientific Title of Study   Comparison of Structural Diagnosis and Management Approach and Myofascial Release for Plantar Heel Pain in Diabetic Patients.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paroshmoni Biswas Mim 
Designation  Undergratuate student 
Affiliation  Jashore University of Science and Technology,  
Address  Bachelor of Physiotherapy Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology Jashore-7408



7408
Other 
Phone  8801312039527  
Fax    
Email  mimb20162@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Lecturer Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology Jashore-7408 Bangladesh.



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Lecturer Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology Jashore-7408 Bangladesh.



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
MSK Lab - Room No: 308, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
 
Primary Sponsor  
Name  Paroshmoni Biswas Mim 
Address  Bachelor of Physiotherapy (BPT), Department of Physiotherapy & Rehabilitation Jashore University of Science & Technology (JUST),Jashore, Bangladesh. 
Type of Sponsor  Other [self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain Clinical Consultant PTR Dept JUST  Dept of Physiotherapy and Rehabilitation, JUST, Jashore-7408, BD.  Department of Physiotherapy and Rehabilitation, JUST, Medical center room no-301 Jashore-7408, Bangladesh.

 		 01778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Department of Physiotherapy and Rehabilitation, JUST   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Myofascial Release (MFR)  Deep stripping on the plantar fascia surface toward the calcaneus with the dosages of (5-7) repetitions with (15-30) seconds hold ewith 1 set. Deep stripping to the triceps surae (gastrocnemius, soleus and plantaris) part of posterosuperficial compartment of the calf with the dosage of (5-7) repetitions with (15-30) seconds hold with 1 set. Deep stripping to lateral compartment of the calf with the dosages of (5-7) repetitions with (15-30) seconds hold with 1 set. 3 sessions per week, Total 12 sessions, 4 weeks.  
Intervention  Structural Diagnosis and Management (SDM) Approach  Calf muscle release in prone position, in the direction of (superior to inferior, inferior to superior, lateral to medial, medial to lateral). That will complete in the three stage (stage-1: apply gental pressure; stage-2: apply firm pressure; stage-3: deep pressure). This pressure depends on the patient’s tolerance with the dosages of 6 repetition of each direction each duration 5 minutes with 2sets. Calf muscle release in rolling technique in supine position with the dosages of 10 rolls of the affected foot with 2 sets. Gastrocnemii and soleus muscles stretch (following the grade-1, 2, and 3). That will complete in three stage (stage-1:dorsiflexion in first one-third; stage-2:dorsiflexion up to middle one-third range; stage-3: dorsiflexion to the full range)with the dosages of 5 to 7 repetitions with 60 seconds hold with 2 sets. Myo-neural stretching in supine lying with 60 seconds hold with 2 set. 3 sessions per week, Total 12 sessions, 4 weeks.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Planter heel pain in diabetic patients
2. Patients who willing to participate
3. Age between (30 to 70 years)
4. Both gender (male and female)
5. Patients with a diagnosis of unilateral or bilateral plantar heel pain, plantar fasciitis, and heel spur.
6. Planter heel pain is associated with plantar fasciitis and calcaneal spur, during the morning
it’s very painful when taking place the foot is on the floor among diabetic patients, and pain
during a long time of standing, after walking and walking on the floor with barefoot.
7. Plantar heel pain with calf muscle tightness and stress on perifascial structure.
8. Any traumatic history (not fracture of the foot)
9. Limited ankle dorsiflexion and activity limitation. 
 
ExclusionCriteria 
Details  1. Patients with active foot ulceration or infection, severe peripheral vascular disease.
2. Patient with contraindications to manual therapy or exercise interventions.
3. Diagnosis of severe osteoporosis, infection, tumor, gangrene, cyanotic symptom.
4. Patient who have any surgery of the foot. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
As primary outcome, Pain, Disability, Activity limitation.  12 Sessions,4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
As secondary outcome, Muscle strength & Range of Motion (ROM)  12 Sessions,4 Weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Planter heel pain is the most common musculoskeletal condition of the lower extremities characterized by plantar fascia pain, perfascial structure pain, in the morning placing the first step on the floor then feel pain most in the foot, during prolonged time standing or walking feel pain, it can be caused for associated risk factors such as (type-1 or type-2 diabetes, obesity, most time stay in weight-bearing position which is more tend to occur heel pain, calcaneal spur). Both the SDM approach and MFR are effective for plantar heel pain but in the previous study where the results showed that the SDM approach is effective for improving heel pain compared with MFR. This study protocol will determine the comparison of the Structural Diagnosis and Management (SDM) Approach and MyoFascial Release (MFR) for plantar heel pain in diabetic patients.
 
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