| CTRI Number |
CTRI/2026/02/103266 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of tele-rehabilitation on fear of movement and daily activities after lumbar endoscopic discectomy surgery |
|
Scientific Title of Study
|
Tele-rehabilitation for post-operative lumbar endoscopic discectomy
patients: A randomized controlled trial evaluating the impact on
Kinesiophobia and disability. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana Palkhade PT |
| Designation |
Professor |
| Affiliation |
B.K.L. Walawalkar college of physiotherapy, Sawarde, Chiplun |
| Address |
Second floor Musculoskeletal Physiotherapy Department S.V.J.C.T.s B.K.L. Walawalkar College of physiotherapy, Kasarwadi, Sawarde, Chiplun
Ratnagiri MAHARASHTRA 415606 India |
| Phone |
8999098176 |
| Fax |
|
| Email |
drmeghanapt@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tejashri S Sawant |
| Designation |
PG student |
| Affiliation |
B.K.L. Walawalkar college of physiotherapy, Sawarde, Chiplun |
| Address |
Second floor Musculoskeletal Physiotherapy Department S.V.J.C.T.s B.K.L. Walawalkar college of physiotherapy, Kasarwadi, Sawarde, Chiplun
Ratnagiri MAHARASHTRA 415 606 India |
| Phone |
8928482319 |
| Fax |
|
| Email |
tejashrisawant06@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Tejashri S Sawant |
| Designation |
PG student |
| Affiliation |
B.K.L. Walawalkar college of physiotherapy, Sawarde, Chiplun |
| Address |
Second floor Musculoskeletal Physiotherapy Department S.V.J.C.T.s B.K.L. Walawalkar college of physiotherapy, Kasarwadi, Sawarde, Chiplun
Ratnagiri MAHARASHTRA 415 606 India |
| Phone |
8928482319 |
| Fax |
|
| Email |
tejashrisawant06@gmail.com |
|
|
Source of Monetary or Material Support
|
| B K L Walawalkar rural hospital and college of physiotherapy, Sawarde Chiplun |
|
|
Primary Sponsor
|
| Name |
Tejashri S Sawant |
| Address |
Second floor Musculoskeletal Physiotherapy Department B K L Walawalkar college of physiotherapy, Sawarde Chiplun
415 606 |
| 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 Tejashri S Sawant PT |
B K L Walawalkar rural hospital |
Second floor Musculoskeletal Physiotherapy Department B K L Walawalkar College of physiotherapy Sawarde Chiplun 415 606 Ratnagiri MAHARASHTRA |
8928482319
tejashrisawant06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B K L Walawalkar rural hospital, diagnostic and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home exercise program |
Group B participants will continue with home exercise |
| Intervention |
Telerehabilitation |
Group A and Group
B. Both groups will receive early-phase spine rehabilitation exercises
in the Inpatient Department from postoperative day 1 until
discharge. Group A participants will continue to receive spine rehabilitation
exercises through telerehabilitation until the next follow-up. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have undergone lumbar endoscopic discectomy
and are willing to participate in the study.
2. Patients with access to smartphone technology. |
|
| ExclusionCriteria |
| Details |
1. Presence of pre-existing neurological conditions (e.g., Stroke, Multiple sclerosis)
2. Patients who have undergone previous spinal or any limb surgery
3. Patients with significant cognitive impairment that may affect their ability to understand and follow instructions
4. Patients with psychological disorders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinesiophobia (TSK-11) |
POD 1 and after 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index & Numerical Rating Scale |
POD 1 & after 6 week |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| Date of Study Completion (India) |
31/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tejashrisawant06@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
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
|
This randomized controlled trial aims to evaluate the effectiveness of telerehabilitation in reducing kinesiophobia and functional disability in patients after lumbar endoscopic discectomy. Although LED is a minimally invasive procedure, many patients experience fear of movement and delayed recovery due to limited access to postoperative rehabilitation. Telerehabilitation offers a remote, accessible alternative to conventional rehabilitation. The study will assess whether telerehabilitation is more effective than home-based exercise programs in improving postoperative outcomes, particularly fear of movement and disability. |