FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [m_sukumar@yahoo.com].

  6. 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.

  7. 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.

 


 
Close