| CTRI Number |
CTRI/2025/07/091124 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| 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
|
Effectiveness of Nerve-Based Physical Therapy for Chronic Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of Function Induced Neural Stretching and Distalo-Proximal Release Technique for the Management of Chronic Low Back Pain with Referred Symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umma Maliha Nitu |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801909464480 |
| Fax |
|
| Email |
mmalihachowdhury@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
sh.jahan@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Room no 301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Dr MR Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room no 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Musculoskeletal Lab, Dr MR Khan Medical Center, Department of Physiotherapy and Rehabilitation |
Room no 301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Dr MR Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Khulna division, Bangladesh
|
8801778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology |
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 |
| Comparator Agent |
Conventional physiotherapy |
Control Group:
Conventional physiotherapy
Warm-Up (5–7 minutes)
Moist Heat Pack to Lumbosacral Area – 5 mins
Pelvic Tilts & Bridges – 2 sets × 10 reps
Main Treatment (20–25 minutes)
Electrotherapy (10–15 mins)
TENS (High-Frequency): 100 Hz, 100 µs, 15 mins
OR
Ultrasound Therapy (as appropriate): 1 MHz, 1.5 W/cm², 8 mins
Exercise Therapy (10–15 mins)
Core Stabilization
Abdominal drawing-in – 2 sets × 10 reps
Bridging – 2 sets × 10 reps
Stretching Exercises
Hamstring stretch – 30 sec × 3
Hip flexor stretch – 30 sec × 3
Functional Strength
Sit-to-stand – 10 reps
Step-ups – 10 reps
Cool Down (5 minutes)
Supine breathing + lumbar rolling (gentle)
Forward bend to tolerance × 3 reps |
| Intervention |
Function Induced Neural Stretching and Distalo-Proximal Release Technique |
Experimental Group:
Function Induced Neural Stretching and Distalo-Proximal Release Technique
Warm-Up (5–7 minutes)
Dynamic Pelvic Tilts – 2 sets × 10 reps
Cat-Cow Stretch – 2 sets × 10 reps
Stationary cycling or treadmill walking (3 mins)
Main Treatment (20–25 minutes)
Function Induced Neural Stretching (10–12 mins)
Sciatic Nerve Gliding: Supine SLR with DF/cervical flexion
3 sets × 10 reps; hold 3 seconds
Femoral Nerve Stretch: Prone knee bend + cervical extension
3 sets × 10 reps; hold 3 seconds
Slump Stretch with Functional Reaching
3 sets × 10 reps
Distalo-Proximal Release Technique (10–12 mins)
Manual release from foot to lumbar region:
Plantar fascia & Achilles tendon release – 2 mins
Calf & hamstrings deep tissue release – 3 mins
Gluteal fascia & piriformis release – 3 mins
Lumbar paraspinals MFR – 3 mins
Cool Down (5 minutes)
Supine Diaphragmatic Breathing – 2 mins
Knee-to-chest stretch – 3 reps × 30 sec
Lumbar rotation stretch – 10 reps |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Men and women aged 18 to 60 years.
Clinically and radiologically diagnosed Chronic Low Back Pain with Referred Symptoms.
Symptoms present for more than 4 weeks.
Positive straight leg raise.
Ability to give informed consent.
|
|
| ExclusionCriteria |
| Details |
History of spinal surgery.
Systemic neurological conditions.
Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain by Visual Analog Scale Score,
Pressure Pain Threshold
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of Motion (ROM) by using Digital Goniometer, Functional Disability by Oswestry Disability Index (ODI), Neural Mobility by Straight Leg Raise and Patient-Specific Functional Scale (PSFS)
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sh.jahan@just.edu.bd].
- For how long will this data be available start date provided 28-03-2026 and end date provided 09-04-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to determine whether Function Induced Neural Stretching and Distalo Proximal Release Technique can produce superior outcomes in pain reduction and functional improvement compared to standard physiotherapy, thereby supporting a potentially more effective therapeutic approach for Chronic Low Back Pain with Referred Symptoms. The findings of this study will contribute to the evidence base for Neural Stretching and Distalo Proximal Release Technique in the conservative management of Chronic Low Back Pain with Referred Symptoms. |