| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|