| CTRI Number |
CTRI/2021/08/035687 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
14/08/2021 |
| 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
|
Use of traction in low back pain |
|
Scientific Title of Study
|
Clinical effectiveness and MRI changes after continuous lumbar traction in patients with low back pain due to lumbar disc herniation at a tertiary care hospital: a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrutha Viswanath |
| Designation |
Postgraduate Student |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Physical Medicine and Rehabilitation
AIIMS Bhubaneswar Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9400032396 |
| Fax |
|
| Email |
amruthaviswanath22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagannatha Sahoo |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Physical Medicine and Rehabilitation
AIIMS Bhubaneswar Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9437081814 |
| Fax |
|
| Email |
pmr_jagannath@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Amrutha Viswanath |
| Designation |
Postgraduate Student |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Physical Medicine and Rehabilitation
AIIMS Bhubaneswar Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9400032396 |
| Fax |
|
| Email |
amruthaviswanath22@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All India Institute of Medical Sciences
Sijua Patrapada
Bhubaneswar Khordha
Odisha 751019 |
| 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 |
| AMRUTHA VISWANATH |
Department of Physical Medicine and Rehabilitation Room number 4 |
AIIMS, Bhubaneswar
Khordha
ODISHA
Khordha
ORISSA |
9400032396
amruthaviswanath22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous lumbar traction with conventional treatment |
Continuous lumbar traction with 1/6 th body weight of the patient for 4 weeks along with coventional treatment which include oral medications and physiotherapy |
| Comparator Agent |
Conventional treatment |
Conventional treatment which include oral medications and physiotherapy for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with low back pain
1)Age 25-55 years
2)Less than 1 year of duration
3)MRI proved herniation of one or more lumbar discs
4)VAS score more than or equal to 5 out of 10 |
|
| ExclusionCriteria |
| Details |
1) Patients with neurological deficits
2) Malignancy,infection
3) Severe osteoporosis
4) Any contraindications to MR imaging (cardiac pacemakers, intracranial clips or implants)
5) Refuse to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinically:
Straight leg raising test
Modified schober’s test
Lateral lumbar flexion test
VAS score
The Roland-Morris low back pain and Disability Questionnaire (RMQ)
Modified Oswestry Low Back Pain Disability Questionnaire
MRI changes:
Spinal canal diameter
Lumbar vertebral column length
Disc reduction ratio
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient Satisfaction
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/08/2021 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low back pain (LBP) is one of the leading causes of work absence and activity limitation throughout the world, and it cause enormous economic burden to society. One common reason for low back pain is herniation of the intervertebral disc. Among several non operative treatments for LBP, lumbar traction is used in clinical practice to treat patients with disc herniation.However, there is only limited evidence to support the effect of traction. This study evaluates the clinical effectiveness and MRI changes after continuous lumbar traction in lumbar disc herniation.This study also compare the effectiveness of continuous lumbar traction with that of conventional treatment in patients with low back pain due to lumbar disc herniation. |