| CTRI Number |
CTRI/2024/10/075629 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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
|
Comparing the Effectiveness of Manipulation Techniques on Pain, Range of Motion, and Disability in Mechanical Low Back Pain: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative efficacy of contact manipulation v/s adjuster techniques on pain, ROM, disability with mechanical low back pain: A Randomised Controlled Trial |
| 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 Sharath Hullumani V |
| Designation |
Assistant professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ground floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964066927 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghuveer Raghumahanti |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ground floor, Department of Neuro Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharath Hullumani V |
| Designation |
Assistant professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ground floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964066927 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
partment of Physiotherapy, Acharya Vinoba Bhave Rural Hospital,Sawangi Meghe ,Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sharath Hullumani |
Acharya Vinoba Bhave Rural Hospital |
Room No.19, Department of Paediatric Physiotherapy, Datta Meghe Institute of Higher Education and Research (DU),Sawangi Meghe
Wardha
MAHARASHTRA |
9964066927
sharathhullumani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Deemed to be University Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Contact Manipulation |
High-Velocity, Low-Amplitude (HVLA) Thrust This is the most common form of manual adjustment used in chiropractic care. It involves a quick and precise force applied to a spinal joint. To restore normal joint motion, reduce pain, and improve function. The Physiotherapist positions the patient in a specific manner, and then a rapid, controlled thrust is delivered to the target joint. This often produces an audible "crack" or "pop."
Spinal Mobilization A gentler form of manual therapy that involves slow and rhythmic movements of the joints. To improve joint function, increase range of motion, and reduce pain. The Physiotherapist uses their hands to apply a steady pressure and gently move the joints through their range of motion without rapid thrusts.
Flexion-Distraction Technique This technique involves a specialized table that moves while the chiropractor performs manual adjustments. To decompress the spine, alleviate pressure on the discs and nerves, and improve overall spinal function. The patient lies face down on a flexion-distraction table, and the chiropractor applies manual pressure while the table moves to gently stretch and decompress the spine.
Manual Traction
A technique where the chiropractor applies a gentle pulling force to stretch the spine. To relieve pressure on the spinal discs and nerves, reduce pain, and improve alignment. The Physiotherapist uses their hands to apply a controlled traction force to the patient’s spine, often while the patient lies on their back or stomach.
for 4 weeks
|
| Comparator Agent |
Standard Treatment |
IFT for 20 minutes
ICE pack for 10 minutes for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with MLBP by a healthcare professional.
No previous spinal surgery or contraindications to spinal adjustments
|
|
| ExclusionCriteria |
| Details |
Non-mechanical causes of low back pain.
Severe comorbidities affecting mobility.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS |
Baseline, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
Baseline, 4th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- 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 [sharathhullumani@gmail.com].
- For how long will this data be available start date provided 18-10-2024 and end date provided 03-10-2027?
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
|
Given the high prevalence of MLBP and the variety of treatment modalities available, it is crucial to determine the most effective intervention for pain relief and functional improvement. This study will provide evidence-based guidance for clinicians in choosing between contact manipulation and adjuster techniques, potentially improving patient outcomes and reducing the socioeconomic burden of MLBP. |