| CTRI Number |
CTRI/2024/06/069282 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Conservative management of low back pain using spine biofeedback device |
|
Scientific Title of Study
|
To assess the clinical and functional outcomes following conservative management of mechanical low back pain with active structured rehabilitation program using spine biofeedback device |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amir Khan |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of sports medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
8411072219 |
| Fax |
|
| Email |
amirkhanafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Bansal |
| Designation |
Associate professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of sports medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
8411072219 |
| Fax |
|
| Email |
surajbansal.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amir Khan |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of sports medicine
Pune
MAHARASHTRA
411040
India |
| Phone |
8411072219 |
| Fax |
|
| Email |
amirkhanafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Devices are Provided by Govt Medical College using public fund at Armed Forces Medical College. Rehabilitation for patient is free of cost. |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Dept of sports medicine AFMC Pune, Maharashtra |
| Type of Sponsor |
Government medical college |
|
|
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 Amir Khan |
Armed Forces Medical College |
Department of Sports Medicine
Pune
MAHARASHTRA |
8411072219
amirkhanafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICALCOMMITTEEARMEDFORCESMEDICALCOLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Study is a quasi experimental study, hence there is no comparator agent |
| Intervention |
Spine biofeedback device |
Spine rehabilitation in sub-acute and chronic mechanical low back pain using spine biofeedback device for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subacute and chronic mechanical low back pain |
|
| ExclusionCriteria |
| Details |
Pregnancy, Vertebral compression fracture, severe progressive neurologic deficit including cauda equina syndrome, spinal infection, spinal neoplasm, inflammatory spondyloarthritis, previous spine surgery and unwillingness due to any reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain severity as per VAS score
Disability as per ODI
Trunk range of motion and strength |
At baseline and 12 weeks post rehabilitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Isolated trunk ROM & strength in patients with mechanical low back pain on first visit & comparison with normal ROM & strength in normal adults |
Baseline at first visit |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="8"
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
- 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
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - contact through mail- amirkhanafmc@gmail.com
- For how long will this data be available start date provided 08-05-2024 and end date provided 08-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A quasi experimental study to assess the clinical and functional outcomes in forms of pain, disability, ROM and strength of trunk muscle, before and after spine rehabilitation using spine biofeedback device with an aim to check the efficacy of device in sub-acute and chronic low back patient |