| CTRI Number |
CTRI/2025/04/084533 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can the manual therapy technique relieve chronic lower back pain by improving trunk flexibility, lumbar curvature, lumbar range of motion and sleep ? |
|
Scientific Title of Study
|
Effectiveness of Primal reflex release technique on lumbar lordosis, lumbar range of motion, trunk flexibility, sleep and wake behaviuor in patients with chronic low back pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mugdha Kumari |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
6299522928 |
| Fax |
|
| Email |
mugdhakumari829@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
D block, Faculty of physiotherapy, SGT University, Budhera, Gurgaon, Haryana 122505,
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
anushree.rai.21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anushree Rai |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
D block, Faculty of Physiotherapy,SGT University, Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
anushree.rai.21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mugdha Kumari |
| Address |
D block, Faculty of Physiotherapy, SGT University, Budhera, Gurugram, Haryana-122505 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Mugdha Kumari |
SGT Hospital |
Basement floor , room no-13,Physiotherapy OPD, SGT Hospital, Budhera, Gurugram , Haryana- 122505
Gurgaon
HARYANA |
6299522928
mugdhakumari829@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercise |
In group B patients are given conventional exercises. |
| Intervention |
Primal Reflex Release Techniuqe |
In group A primal reflex release technique of four muscles- hamstring, lumbar, piriformis and iliopsoas holding for approximately 12 seconds each |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient age between 18 to 45 years either of the gender
Patient having low back pain for more than 3 months
Pain intensity greater than 3 on 0 to 10 numerical pain rating scale
Patient who is not undergoing any treatment |
|
| ExclusionCriteria |
| Details |
Any neurological deficit, History of surgery, Any diagnosed respiratory conditions, Psychiatric disorders, Pregnancy, Any medication which may affect sleep, Diagnosed with sleep disorders(insomnia),PIVD, Underlying condition (such as cancer, infection or cauda equina syndrome), Spinal stenosis, Radiating pain occurring in the back
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lumbar range of motion, lumbar lordosis, trunk flexibility, sleep and wake behaviour |
At baseline, at the end of 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
18/04/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Chronic back pain is defined as back pain that persists for 12 weeks or longer even after an initialinjury or underlying cause of acute back pain has been treated. IT is a common health issue that can significantly impact quality of life, including physical activity, mental health and overall productivity. Chronic back pain affects about 10-20% of adults globally, depending on the population and study methods. It is one of the most common reasons for disability world wide.The primal reflex release technique is a treatment paradigm theorized to decrease pain and muscle spasm by targetting, resetting reflexes and using reciprocal inhibition to down regulate the autonomic nervous system. This study aims to determine the effectiveness of primal reflex release technique on lumbar lordosis, lumbar range of motion, trunk flexibility and sleep and wake behaviour in patients with chronic low back pain. This study will be a randomized control trial and will be conducted at SGT Hospital in Gurugram. A sample size of 48 patients will be taken in this study using convenient sampling technique. Patients will be randomly assigned into two groups. Group A will be treated by Primal reflex release technique and group B will be treated by conventional exercise. Lumbar lordosis and lumbar range of motion will be measured by inclinometre, trunk flexibility by fingertip to floor test and pittsburg sleep diary to know about the sleep and wake behaviour. The evaluation will be done on day 1 as pretreatment values and at 4 week as post treatment values respectively. |