| CTRI Number |
CTRI/2026/02/104497 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Jacobsons Relaxation Training on Fear of movement or reinjury following Anterior Cruciate Ligament Reconstruction surgery in Goa |
|
Scientific Title of Study
|
Effectiveness of Jacobsons Progressive Muscle Relaxation Training on Kinesiophobia in individuals following Anterior Cruciate Ligament Reconstruction surgery in a tertiary health centre in Goa A Quasiexperimental 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 |
Everly Fernandes |
| Designation |
Post graduation student |
| Affiliation |
Goa Medical College and Hospital Bambolim Goa |
| Address |
Allied health science
Department of Orthopaedics
Goa Medical College and Hospital Bambolim
NH17 Tiswadi
North Goa
North Goa
GOA
403202
India |
| Phone |
8805088501 |
| Fax |
|
| Email |
fernandeseverly61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alisha Gracias |
| Designation |
Assistant professor |
| Affiliation |
Goa Medical College and Hospital Bambolim Goa |
| Address |
Allied health science
Department of Orthopaedics
Goa Medical College and Hospital Bambolim
NH17 Tiswadi
North Goa
North Goa
GOA
403202
India |
| Phone |
98818 87175 |
| Fax |
|
| Email |
alisha.gracias@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Everly Fernandes |
| Designation |
Post graduation student |
| Affiliation |
Goa Medical College and Hospital Bambolim Goa |
| Address |
Allied health science
Department of Orthopaedics
Goa Medical College and Hospital Bambolim
NH17 Tiswadi
North Goa
North Goa
GOA
403202
India |
| Phone |
8805088501 |
| Fax |
|
| Email |
fernandeseverly61@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Everly Fernandes |
| Address |
Allied health science
Department of Orthopaedics
Goa Medical College and Hospital
Bambolim
NH17 Tiswadi North Goa
403202 |
| 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 |
| Everly Fernandes |
Goa Medical College and Hospital |
Ward 103 and 105
Department of Orthopaedics Goa Medical College and Hospital Bambolim
NH 17 Tiswadi North Goa
North Goa
GOA |
8805088501
fernandeseverly61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy |
participants will receive conventional physiotherapy including cryotherapy, range of motion exercises, strengthening exercises and functional training as per the protocol
10 repitition per session two times per day for 6 days per week |
| Intervention |
Jacobsons Progressive Muscle Relaxation Training |
Participants will receive Jacobsons Progressive Muscle Relaxation Training along with conventional physiotherapy. JPMRT will be administered for 20 to 30 minutes per session, 3 sessions for 3 days under supervision. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals undergoing primary ACL reconstruction with hamstring graft
Baseline score of 37 or above on TSK 17 scale indicating clinical kinesiophobia
Able to read and write in English and Konkani
Follow up in Goa Medical College and Hospital
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinesiophobia using Tampa scale 17 |
Pre intervention baseline
Post intervention day 3 and post op day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain using VAS |
Baseline pre intervention
Post intervention day 3 & day 14 post op |
| Functional status with timed up and go test |
Post intervention day 3 and day 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/03/2026 |
| 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="11"
Days="30" |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [fernandeseverly61@gmail.com].
- For how long will this data be available start date provided 20-06-2027 and end date provided 20-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A quasiexperimental study to determine the effect of Jacobson’s Progressive Muscle Relaxation Training on Kinesiophobia as primary outcome, pain and functional status as secondary outcome in individuals following Anterior Cruciate Ligament Reconstruction surgery. Participants will receive intervention at post operation day 1,2,3 along with conventional physiotherapy. Each session will be for 20 to 30 minutes. Pre intervention measurements will be taken at post op day 1 followed by post intervention outcome measuring will take place at day 3 of after the session. At 14 post op day measurements will be taken to check for short term effects. |