| CTRI Number |
CTRI/2025/02/080470 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of muscle release among Knee Osteoarthritis Subjects. |
|
Scientific Title of Study
|
Effect Of Spiral Line Soft Tissue Release On Clinical Outcomes Among Subjects With Degenerative Disease Of Knee: A Quasi Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Batul Patanwala |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute Of higher Education And Research (Deemed to be university) |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty Of Physiotherapy, SRIHER(Deemed to be university) INDIA.
Ramachandra Medical College, Trunk Road,Sri Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
08015299382 |
| Fax |
|
| Email |
batulmp2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soundararajan K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of higher Education And Research (Deemed to be university) |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty Of Physiotherapy, SRIHER (Deemed to be university) INDIA.
Ramachandra Medical College, Trunk Road,Sri Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
09551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Soundararajan K |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of higher Education And Research (Deemed to be university) |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty Of Physiotherapy, SRIHER (Deemed to be university) INDIA.
Ramachandra Medical College, Trunk Road,Sri Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
09551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research, Sri Ramachandra Nagar, Porur, Chennai 600 116 |
|
|
Primary Sponsor
|
| Name |
Ms Batul |
| Address |
Physical Rehabilitation Department, Ground Floor, New Block, Faculty Of Physiotherapy, SRIHER(Deemed to be university) INDIA.
Ramachandra Medical College, Trunk Road,Sri Ramachandra Nagar, Porur, Chennai 600 116 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Batul Patanwala |
Sri Ramachandra Institute Of Higher Education And Research |
Ground floor, Physical Rehabilitation, New Block OPD
Sri Ramachandra Institute of Higher Education And Research, Trunk Road, Sri Ramachandra Nagar, Porur, Chennai 600 116, Tamilnadu
Chennai
TAMIL NADU |
8015299382
batulmp2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Student Project,SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine gold standard physiotherapy Treatment for Knee Osteoarthritis |
Including both electrotherapy and manual therapy protocol along with home exercise program. DURATION 45 to 60 minutes.
At the Baseline, at end of the 2nd week, 4th week, 8th week and 12th week |
| Intervention |
Spiral Line Soft Tissue Release |
Along with the standard physiotherapy protocol of knee osteoarthritis, patients will additionally receive spiral line soft tissue release.
The Myofascial release will be given according to the principles and method of Thomas J Myer.
The muscles under the spiral line are:
- Splenius Capitus
- Rhomboids
- Serratus anterior
- Erector spinae
- Sacrotuberous ligament
- Iliotibial Band
- Biceps femoris
- Tibialis anterior
Duration 45 to 60 Minutes
At the Baseline, at end of the 2nd week, 4th week, 8th week and 12th week.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with knee osteoarthritis.
2. Pain score of more than 4 on visual analogue scale (VAS).
3. Sit to reach test restriction (1-15cm for men and 5-16cm for women).
4. Ability to ambulate independently without any assistive devices.
5. Willingness to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Severe Comorbidities affecting mobility (eg. Severe cardiovascular disease, neurological disorders)
2. Recent knee surgery or trauma
3. Contraindications to manual therapy (eg severe Osteoporosis, active infections, recent fracture, open wounds, hypermobility, rheumatoid arthritis, malignancy)
4. Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Knee Range of Motion
2. Visual Analogue Scale
3. Knee Injury And Osteoarthritis Outcome Score (KOOS)
4. Sit to reach test
5. Pain pressure Algometer |
Baseline, at the end of 4th week, 6th week, 8th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical Performance Test, Muscle Strength |
Baseline, at the end of 4th week, 6th week, 8th week, 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
INTRODUCTION: Knee osteoarthritis is identified among the common causes of disability worldwide. Therapist are more focused on strengthening the muscles around the knee rather than stretching it. An increased number of empirical studies
are being conducted on myofascial release in knee OA patients, and they state
the equal importance of myofascial release.
Anatomical spiral line release is a type of effective hands on interactive method that provides stretching, compression and sustained pressure into the restricted areas of the fascia The anatomic line release is based on
the tensegrity principle, and hence, the entire line of fascia
needs to be released instead
of the single muscle to bring about complete and long-lasting relief of
symptoms.
AIM: To Evaluate the effects of spiral line release on knee osteoarthritis subjects.
METHADOLOGY:
STUDY DESIGN: A Quasi experimental study STUDY DURATION: 4 weeks RANDOMISATION: Block randomization. Method of generating random sequence: computer generated randomization. Method of concealment: Sequentially numbered, sealed, opaque envelopes Method of block randomization: block size is 4 and total blocks needed is 15. |