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CTRI Number  CTRI/2019/06/019700 [Registered on: 17/06/2019] Trial Registered Prospectively
Last Modified On: 13/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The Efficacy Of Instrumental-Aided Soft Tissue Mobilization (IASTM)Versus Manual Stretching In Treatment Of Myofascial Pain In Subjects With Osteoarthritis Knee  
Scientific Title of Study   The Efficacy of Instrumental- aided soft tissue mobilization (IASTM)versus manual stretching in treatment of myofascial pain in subjects with Osteoarthritis knee-A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Bhaskar Chate 
Designation  PG student  
Affiliation  sancheti institute college of physiotherapy 
Address  Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Pune
MAHARASHTRA
411005
India 
Phone  8275268644  
Fax    
Email  chateswati555@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sona Kolke 
Designation  Musculoskeletal Physiotherapy 
Affiliation  sancheti institute college of physiotherapy 
Address  Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Pune
MAHARASHTRA
411005
India 
Phone  9371004121  
Fax    
Email  sona.sarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swati Bhaskar Chate 
Designation  PG student  
Affiliation  sancheti institute college of physiotherapy 
Address  Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Sancheti healthcare academy , Sancheti institute college of physiotherapy , 11/12 thube park , shivajinagar
Pune
MAHARASHTRA
411005
India 
Phone  08975970588  
Fax    
Email  chateswati555@gmail.com  
 
Source of Monetary or Material Support  
Sancheti institute college of physiothaerpy shivaji nagar pune,thube park 11/12 Sancheti institute college of physiothaerpy shivaji nagar pune,thube park 11/12  
 
Primary Sponsor  
Name  Sancheti institute college of physiothaerpy 
Address  Sancheti institute college of physiothaerpy shivaji nagar pune,thube park 11/12  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
swati bhaskar chate  Sancheti Institute College of Physiotherapy  Sancheti healthcare academy,sancheti institute college of physiotherapy, 11/12 Thube park,shivajinagar,pune
Pune
MAHARASHTRA 
8275268644

Chateswati555@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB_SIOR/Agenda 054  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instrument-aided soft tissue mobilization  one week two seesion 
Comparator Agent  Manual stretching  1.Hot pack 10 min 2. Manual stretching of involved muscle. Each stretch held for 20 sec/2 reps. 3.post-treatments Ice pack for 10 min. 4.Home program. 2 session/ per ones week  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Age groups 40 to 55 years both male and female
GRADE 1 TO GRADE 4 with pain >3 and <8 pain on VAS
Presence of myofascial pain or soft tissue restrications.
 
 
ExclusionCriteria 
Details  1.Any recent trauma.
2.Any resent surgical /medical history.
3.Patients with hypersensitive skin or with any skin conditions like Dermatitis.
4.Patients with any neuromuscualr conditions with reduced sensation.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
pain-Quadruple pain rating scale.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
this scale used in pre treatments intervention and post treatment intervention.
 
30 min 
 
Secondary Outcome  
Outcome  TimePoints 
TUG(Time UP and Go test)
Pressure algometry for trigger points. this scale used in pre treatments intervention and post treatment intervention.
 
30 min 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The Efficacy of Instrument-aided soft tissue mobilization
(IASTM) versus manual stretching in treatment of myofascial
pain in subjects with Osteoarthritis knee – A Randomized
Control Trial.

 Introduction :-
Knee osteoarthritis (OA) is degenerative and chronic disease of knee joint resulting from damage to
hyaline cartilage and is most common type of arthritis affecting mainly older population.[1]It has a prevalence of 12.5% in population aged 45 year and above and is a multifactorial etiology which includes acute and / or chronic insults from normal wear and tear, age, obesity, and joint injury. [1],[2]
The pain and stiffness, motion limitations, motor and sensory dysfunction and functional impairments, can be severe in advanced stages which might interfere with day to between patients reports of pain and their radiographic findings with a plausible explanation of the pain originating from the myofascial trigger points (MTrPs) in the surrounding muscles[myofascial pain] which cannot be visualized by imaging. [4][5][6] Myofascial hyperirritable spots found in the skeletal muscle are associated with sensitive palpable nodule located in a taut bands, which are painful on compression and may produce characteristic referred pain, referred tenderness, motor dysfunction ,and autonomic phenomena. Two different types of MTrPs have been

[Page : 2] described: 1) active MTrPs which are associated with spontaneous pain; 2) latent MTrPs which elicit pain only on palpation and do not cause pain spontaneously. It has been speculated that these latent MTrPs are responsible for altered motor recruitment pattern and restriction in ranges. [7][8]
The most common sites of MTrPs is include Vastus lateralis, Vastus medialis, Biceps femoris, Semitendinosus, Gastrocnemius. With a better understanding of the myofascial component of OA knees,
treatments focusing on it is effective in reducing pain and improving function in patients with knee OA. [9]
Conventionally the soft tissue restrictions have been treated with superficial heat/cold along with manual stretching.With advent of soft tissue mobilization, various manual MFR (Myofascial release) techniques have gained popularity. MFR techniques focus directly on these restricted myofascial elements, thus releasing the resulting restrictions and pain. Instrument assisted soft tissue mobilization (IASTM) is emerging as a popular treatment for myofascial restriction. The rationale of treatment is based on the concept of James Cyriax, but instead of using digital cross-friction, specially designed instruments are used to give the myofascial mobilization.[10]These tools give the therapist an added advantage of more deeper penetration
and reduced the stress on the hands. The tools also increase the perception of vibrations when moved over altered tissues[eg adhesions/restrictions] and help direct specific treatment towards it. [11][12][13]
The IASTM treatment is hypothesized to stimulate the remodeling of connective tissues through resorption of excessive fibrosis along with inducing repair and regeneration of collagen. This will result in the release and breakdown of scar tissue, adhesions, and fascial restrictions. In laboratory studies using a rat model,
these changes have been documented and similar studie [Page : 3] also found significant short-term (4 weeks) increase in ligament strength and stiffness. Although these changes are not confirmed in human trials. 14][15][16]  There are various IASTM tools used in practice today. The Edge tool has been ergonomically designed to offer several different hand holds and eliminate operator fatigue. The
protocol usually involves treating each restriction for 30-60 seconds with post treatment icing. This is followed by appropriate exercises to the myofascia and the general principle of IASTM is to enhance myofascial mobility with limited adverse effects such as discomfort during or bruising (eg. petechiae) after treatment. [17-26] Even though the treatment method is gaining popularity amongst therapists, there are limited good quality studies documenting the efficacy of IASTM.
 
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