| CTRI Number |
CTRI/2025/07/090107 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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
|
TO COMPARE THE EFFETIVENESS OF TRIGGER RELEASE ON PESANSERINUS OVER CONVENTIONAL PHYSIOTHERAPY IN OSTEOARTHRITIS KNEE INDIVIDUALS |
|
Scientific Title of Study
|
THE STUDY TO COMPARE THE EFFICACY OF TRIGGER RELEASE ON PESANSERINUS OVER CONVENTIONAL THERAPY ON PAIN, RANGE OF MOTION AND FUNTIONAL ACTIVITY IN OA KNEE PATIENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M SUKUMAR |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
DR. MGR Educational and Research institute |
| Address |
Faculty of physiotherapy, Poonamalee high road,
Velappanchavadi,
Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9884350707 |
| Fax |
|
| Email |
m_sukumar@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
MOHAN KUMAR. G |
| Designation |
PROFFESSOR |
| Affiliation |
DR. MGR Educational and Research institute |
| Address |
Faculty of Physiotherapy,
Poonamalee high road,
Velappanchavadi
Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9791072249 |
| Fax |
|
| Email |
mohankumar.physio@drmgrdu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
M SUKUMAR |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
DR. MGR Educational and Research institute |
| Address |
Faculty of Physiotherepy,
Poonamalee high road,
Velappanchavadi
Chennai
Chennai TAMIL NADU 600077 India |
| Phone |
9884350707 |
| Fax |
|
| Email |
m_sukumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NIL |
| Physiotherapy Out patient department, ACS Medical college Hospital |
|
|
Primary Sponsor
|
| Name |
Dr MGR Educaional and research Institute |
| Address |
Physiotherapy OPD, ACS medical college Hospital,
poonamalee high road,
velappanchavadi
chennai 77 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| M S Physiotherapy Clinic |
122, KOVILPADAGAI MAIN ROAD,
KOVILPADAGAI, AVADI, CHENNAI 600062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M SUKUMAR |
ACS medical college Hospital |
Physiotherapy OPD,
poonamalee high road, velappanchavadi,
chennai 600077 Chennai TAMIL NADU |
09884350707
m_sukumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics committee, ACS Medical college hospital |
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 |
CONVENTIONAL THERAPY |
TRANCUTANEOUS ELECTICAL NERVE STIMULATION WITH KNEE EXERCISE IN OA KNEE PATIENTS |
| Intervention |
TRIGGER RELEASE |
TRIGGER RELEASE TECHNIQUE ON PES ANSERINE MUSCLE ALONG WITH KNEE EXERCISE IN OA KNEE PATIENTS |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with grade 2 or 3 OA of the knee radiologically, according to the Kellgren-Lawrence scale (12).
2. Patients diagnosed with OA knee by clinical examination., as defined by American college of Rheumatology
3. Able to ambulate
4. Pain rating greater than 3 in NPRS grading
|
|
| ExclusionCriteria |
| Details |
1. Patients with bilateral OA knee
2. Patients with deformities & contractures
3. Uncontrolled diabetes and hypertension
4. Dementia
5. Neurological disorder
6. Patients who have anesthetic skin
7. Case of open wounds
8. Traumatic O.A. knee
9. Any other surgeries in and around knee
10. Intra articular injection in last 4 weeks
11. Infective arthritis,
12. Inflammatory joint disorders
13. Other Rheumatoid disorders
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the effectiveness of Trigger release on pesanserinus muscle with exercise in reducing the pain in Osteoarthritis knee. |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the effectiveness of Trigger release on pesanserinus muscle with exercise in improving Range of Motion in Osteoarthritis knee. |
4 weeks |
| To find the effectiveness of Trigger release on pesanserinus muscle with exercise in improving the functional activities in Osteoarthritis knee. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
15/07/2025 |
| 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="1" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [m_sukumar@yahoo.com].
- For how long will this data be available start date provided 07-02-2027 and end date provided 13-01-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoarthritis (OA)
is a debilitating, degenerative disease affecting the articular cartilage of
aging joints, it is a leading cause of pain and disability among adults over
the age of 45. Pain is the primary symptom of this disease, which often leads
to disability. As life expectancy increases, so does the number of
people suffering from degenerative joint disease and especially from
OA.
Heat or
electrical nerve stimulation in the form of TENS commonly used for
pain relief and quadriceps exercise has been the main stay for the
treatment of OA Knee. But the results achieved are not always satisfactory.
Other forms of treatment technique has been used time and again with varying
results. There is always room for different treatment technique which are
simple, cost effective and patient acceptance.
Pesanserinus is
combination of tendinous insertions of sartorius, gracilis and
semitendinosus muscles There is an association
between pesanserine syndrome and OA knee, with 20 to 46
percent of patients with symptomatic knee arthritis also having pes anserine
syndrome. Pes anserinus tendinitis/bursitis is a frequent cause of knee pain in
patients with knee OA which should be considered in patients with localized
periarticular symptoms or signs. Valgus deformity increases the possibility of
this condition by 5.2 times and collateral instability increases the
development of tendinitis or bursitis by 6 times .
Trigger point is a
hyper irritable spot, a palpable nodule in the taut band of the skeletal muscle
fascia. Jump sign is the characteristic response to the pressure on the trigger
point. Trigger point therapy is a neuromuscular therapy designed to speedup
recovery from injury, correct muscular imbalance and relieve pain. The
physiotherapist will stretch the muscle and apply pressure to the area of
muscle tightness or Knots. This helps to relieve muscle spasm and promote
healing
This study aims to find
the efficacy of trigger release on pesanserine muscle in relieving pain,
improving range of motion of knee join and improving functional activity in
osteoarthritis knee patients.
|