| CTRI Number |
CTRI/2025/07/091799 [Registered on: 27/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patients with derangement syndrome of low back pain will be assessed for pain and functional status and will be given the directional preference exercise to centralize and reduce the symptoms. |
|
Scientific Title of Study
|
Effectiveness of the Mckenzie Approach in managing Lumbar Derangement Syndrome in Jamnagar District |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoraniya Rutvika Jayantibhai |
| Designation |
PG Physiotherapy student |
| Affiliation |
Government Physiotherapy College, Jamnagar |
| Address |
Exercise Therapy Department OPD, Government Physiotherapy College, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
6354980778 |
| Fax |
|
| Email |
rutvikabhoraniya8704@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dineshkumar Sorani |
| Designation |
InCharge Principal and Senior Lecture of Government Physiotherapy college ,Jamnagar |
| Affiliation |
Government Physiotherapy College, jamnagar |
| Address |
Government Physiotherapy College, Old T.B. Hospital, near dental college, Rameshwar Nagar, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426786167 |
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhoraniya Rutvika Jayantibhai |
| Designation |
PG Physiotherapy Student |
| Affiliation |
Government Physiotherapy College, Jamnagar |
| Address |
Exercise Therapy Department OPD, Government Physiotherapy College, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
6354980778 |
| Fax |
|
| Email |
rutvikabhoraniya8704@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Physiotherapy College, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College Jamnagar |
| Address |
Government Physiotherapy College, near dental college, Rameswar Nagar, Jamnagar |
| 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 |
| Rutvika Bhoraniya |
Government Physiotherapy College, Jamnagar |
Exercise Therapy
OPD, Government
Physiotherapy
College, near dental College, Rameshwar Nagar, Jamnagar
Jamnagar
GUJARAT |
6354980778
rutvikabhoraniya8704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee shree m.p.shah govt. medical college and g.g.govt. hospital, jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mckenzie Approach in Lumbar Derangement Syndrome |
Mckenzie Derangement Protocol (based on bias principle) + Intermittent Lumbar Traction + Interferential Therapy within 2 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 18–65 years diagnosed with low back pain associated with derangement syndromes
patients willing to provide informed consent for participation
|
|
| ExclusionCriteria |
| Details |
patients with Cognitive and Language deficits
patients with red flag conditions (e.g., fractures, infections, malignancies).
patients with non-derangement syndromes.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index
NPRS (Numerical Pain Rating Scale)
|
Baseline (on 1st day) and within 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
Baseline (on 1st day) & within 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
11/08/2025 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
we will collect the data of patients coming to government physiotherapy college- opd, jamnagar. patients who fit selection criteria will be selected. consent will be taken from patients and patients with derangement syndrome of low back pain will be assessed for pain and functional status. treatment will be given as per mckenzie protocol for 2 weeks and post intervention assessment will be taken at 2 weeks. data will be collected over a period of 8 months. |