| CTRI Number |
CTRI/2022/08/044938 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of lumbar spine manipulation on sympathetic skin response and disability in chronic low back pain patients |
|
Scientific Title of Study
|
Effectiveness of lumbar spine manipulation on sympathetic skin response and disability in patients with chronic low back pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Kalra |
| Designation |
MPT Student |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM(DU) |
| Address |
MAHARISHI MARKANDESHWAR DEEMED TO BE UNIVERSITY
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION
Ambala
HARYANA
133207
India |
| Phone |
7015426087 |
| Fax |
|
| Email |
sahilkalrask01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manu Goyal |
| Designation |
Professor & Principal |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM(DU) |
| Address |
MAHARISHI MARKANDESHWAR DEEMED TO BE UNIVERSITY
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Manu Goyal |
| Designation |
Professor & Principal |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM(DU) |
| Address |
MAHARISHI MARKANDESHWAR DEEMED TO BE UNIVERSITY
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Physiotherapy Research lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Sahil Kalra |
| Address |
Musculoskeletal Physiotherapy Research lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Manu Goyal |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sahil Kalra |
Musculoskeletal out patient department, Department of Musculoskeletal |
Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207
Ambala
HARYANA |
7015426087
sahilkalrask01@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee |
Approved |
| Communication of Decision of the Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental group |
Experimental Group receives lumbar spine manipulation and conventional physiotherapy for 2 times a week for consecutive 3 weeks.
Sham group receives only conventional physiotherapy for 2 times a week for consecutive 3 weeks. |
| Comparator Agent |
Sham group |
This group receives conventional physiotherapy only. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Both males and females of age 19-40 years
2 chronic mechanical low back pain
from last 3 months
3. Minimum score of 10 on Modified Oswestry
Disability Index |
|
| ExclusionCriteria |
| Details |
1. Neurological condition: Nerve compression and
cauda equina syndrome
2. Osteoporosis and osteopetrosis
3. Aortic aneurysm and haemophillic joints
4. All known mechanical conditions of low back
pain
5. Uncoperative patients
6. Pregnancy
7. Malignancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Galvanic skin response Biofeedback |
baseline and post treatment (immediate) follow up after last session of 3 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Oswestry disability index |
baseline and post treatment (immediate) follow up after last session of 3 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2022 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ETHICAL STATEMENT
Ethical
clearance will be received by the institutional Research Ethical Committee of Maharishi Markandeshwar (Deemed to be University)
Mullana, Ambala, Haryana and will be done in accordance with Helsinki
declaration revised 2013 and National Ethical Guidelines for Biomedical
Research involving Human Participants, 2017.
Recruitment and intervention Mobilization/Manipulation is used
as an effective intervention in the management of patients with chronic low
back pain. Pain
and sympathetic activity have shown to be associated closely and it is of
utmost importance for physiotherapists to consider the impact of intervention
on the sympathetic nervous system. Participants will receive two treatment sessions per week for consecutive 3 weeks. They will be assessed before and after the interventions and follow up after 3 weeks. There will be two treatment groups experimental group and the sham group. experimental group receive lumbar manipulations and conventional physiotherapy. Sham group receives only conventional therapy
|