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CTRI Number  CTRI/2025/07/090695 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
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   Comparative effect of two treatment methods, Action Observation Therapy and Conventional Therapy on fear of movement, pain and functional disability in patients with tennis elbow. 
Scientific Title of Study   Comparative effect of Action Observation Therapy with Conventional Therapy and Conventional Therapy alone on kinesiophobia, pain and functional disability in patients with lateral epicondylitis: a randomized controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorva Andhare 
Designation  Post-graduate student 
Affiliation  Physiotherapy teaching and treatment center LTMMC Sion Mumbai Maharashtra 
Address  Physiotherapy OPD

Mumbai
MAHARASHTRA
400022
India 
Phone  7758942862  
Fax    
Email  apoorvaandhare81@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Rajashree Naik 
Designation  Head of Department  
Affiliation  Physiotherapy teaching and treatment center LTMMC Sion Mumbai Maharashtra 
Address  Physiotherapy OPD

Mumbai
MAHARASHTRA
400022
India 
Phone  9892728477  
Fax    
Email  rajvinaik@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Rajashree Naik 
Designation  Head of Department  
Affiliation  Physiotherapy teaching and treatment center LTMMC Sion Mumbai Maharashtra 
Address  Physiotherapy OPD

Mumbai
MAHARASHTRA
400022
India 
Phone  9892728477  
Fax    
Email  rajvinaik@rediffmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Apoorva Andhare 
Address  Physiotherapy teaching and treatment center LTMMC Sion Mumbai Maharashtra India 400022  
Type of Sponsor  Other [Self] 
 
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 
Dr Rajashree Naik  Lokmanya Tilak Municipal Medical College and General Hospital Sion  Physiotherapy OPD
Mumbai
MAHARASHTRA 
9892728477

rajvinaik@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Action Observation Therapy  Patients will be made to sit in a quiet room to observe video clips on laptop for 2 minutes and perform the same for 2 minutes. The videos are tailored according to patients activity limitations. The videos to be shown are as follows 1. Wringing a cloth 2) Opening a container lid 3) Lifting a glass filled with water towards the mouth 4) Grasping and moving an object (a sponge ball) in varied planes. Total 12 sessions will be given for 3 times a week for 4 weeks. 
Intervention  Conventional Therapy  Conventional Therapy for lateral epicondylitis includes physiotherapeutic exercises like range of motion exercises, stretching, strengthening and patient education. Total 12 sessions will be given for 3 times a week for 4 weeks. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients clinically diagnosed with lateral epicondylitis of dominant extremity.
2) Patients with lateral epicondylitis having kinesiophobia.
3) Pain intensity on activity – 3 to 7 on NPRS. Pain intensity at rest- 0 on NPRS.
4) Patients who read, understood and responded to the scales translated in Marathi language.
 
 
ExclusionCriteria 
Details  1) History of traumatic injury or surgery to upper quadrant.
2) Any other upper quadrant musculoskeletal disorder.
3) Cognitive impairment

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Scales
1) Tampa Scale of Kinesiophobia (TSK-11)
2) Patient-rated Tennis Elbow Evaluation Scale( PRTEE scale) 
1) Pre- intervention
2) Post-intervention 2nd week
3) Post-intervention 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   Phase 2 
Date of First Enrollment (India)   21/07/2025 
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="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  

The aim of this study is to compare the effect of Action Observation Therapy with Conventional Therapy and Conventional Therapy alone on kinesiophobia, pain and functional disability in patients with lateral epicondylitis. 54 patients clinically diagnosed with lateral epicondylitis between 35 to 50 years of age will be recruited based upon the inclusion criteria and were divided into 2 groups by random allocation, using chit method. Patients in Group A will receive Action Observation Therapy along with Conventional Therapy.  Patients in Group B will receive only Conventional Therapy. Tampa Scale of Kinesiophobia 11 and Patient Rated Tennis Elbow Evaluation Scale will be used as outcome measures to assess kinesiophobia and pain and functional disability respectively. Data will be collected at 3 different timelines that is pre intervention, post intervention at 2nd week and post intervention 4th week.  Collected data will be illustrated in tabular form and analyzed.

Lateral epicondylitis (tennis elbow) describes an overuse injury due to overload of the common extensor tendon origin.  The point of maximal tenderness is usually over the lateral epicondyle. Activity worsens the pain and produces kinesiophobia that is fear of movement, and affect the functional activities of daily living. There are techniques to modulate the pain perception through corticothalamic networks and neural plasticity Action Observation Therapy is one such technique which involves observing purposeful actions with the intention of imitating and then practicing those actions. This approach works through the mirror-neural system of the brain.  Addition of Action Observation to conventional physiotherapy can control kinesiophobia and functional disability associated with lateral epicondylitis. Kinesiophobia can have negative influence on the functional outcome and long term recovery. Action Observation therapy might provoke the cortical activations similar to the actual movement execution and reverse the maladaptive neuroplastic changes associated with pain. The associated functional disability might get lessened and produce a greater rehabilitation outcome. Thus, there is a need to find the effect of Action observation therapy on kinesiophobia, pain and functional disability in patients with lateral epicondylitis.

The objectives of this study is to assess kinesiophobia in patients with lateral epicondylitis using Tampa scale of Kinesiophobia TSK 11,  pain and functional disability using Patient Rated Tennis Elbow Evaluation, the effect of Action Observation Therapy with Conventional Therapy on kinesiophobia, pain and functional disability in patients with lateral epicondylitis  and the effect of Conventional Therapy alone on kinesiophobia, pain and functional disability in patients with lateral epicondylitis. The objectives also include comparing the effect of Action Observation Therapy with Conventional Therapy and Conventional Therapy alone on kinesiophobia, pain and functional disability in patients with lateral epicondylitis.

The materials required will be electronic device to showcase videos for action observation therapy, pen, paper, plinth and chair. The tools required will be Numerical pain rating scale to include patients having pain intensity from 3 to 7, Tampa scale of kinesiophobia to asses kinesiophobia and Patient Rated Tennis Elbow Evaluation scale to asses pain and functional disability.

Thus the study will find out whether adding Action Observation Therapy to Conventional Therapy will make a difference in effect in patients with lateral epicondylitis.

 

 

 

 

 
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