| 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 |
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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 |
|
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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 |
|
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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
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB_SIOR/Agenda 054 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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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. |