| CTRI Number |
CTRI/2025/09/094817 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| 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
|
The Effectiveness Of Mulligan Bent Leg Raise and Muscle Energy Technique in Non-specific Low Back Pain. |
|
Scientific Title of Study
|
Effectiveness Of Mulligan Bent Leg Raise Technique Versus Muscle Energy Technique On Patients with Hamstring Tightness, Pain and Functional Disability in Acute Non-Specific Low Back Pain- A Randomized Clinical 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 |
Pranjali Somnath Ghode |
| Designation |
Postgraduate student |
| Affiliation |
Dr. G.D. Pol Foundation YMT College of Physiotherapy. |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9004834854 |
| Fax |
|
| Email |
gpranjali999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amit Ambulkar |
| Designation |
Professor |
| Affiliation |
Professor at Dr. G.D. Pol Foundation YMT College of Physiotherapy. |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9730831186 |
| Fax |
|
| Email |
ambulkaramit444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranjali Somnath Ghode |
| Designation |
Postgraduate student |
| Affiliation |
Dr. G.D. Pol Foundation YMT College of Physiotherapy. |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9004834854 |
| Fax |
|
| Email |
gpranjali999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pranjali Somnath Ghode |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210 |
| Type of Sponsor |
Private 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 |
| Pranjali Ghode |
YMT COLLEGE OF PHYSIOTHERAPY, KHARGHAR, NAVI MUMBAI |
Room no.305, Musculoskeletal OPD,Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA |
9004834854
gpranjali999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT COP Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan bent leg raise |
4 weeks of Mulligan bent leg raise in non specific low back pain |
| Comparator Agent |
Muscle energy technique group |
4 weeks of muscle energy technique group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Active Knee extension test [AKET] (greater than 20 of knee extension lag) (Unilateral)
2.LBP less than 6 weeks
3.Participants willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Participants with LBP with trauma
2. LBP with specific pathology
3. Previous surgeries of lumbar spine
4. Any neurological symptoms involving prolapsed intervertebral disc
5. Tumor of the spine
6. Spondylolisthesis, Ankylosing spondylitis
7. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 11- point Numerical Pain Rating scale (NPRS-11) for pain
2. Universal Goniometer for range of motion
3. Active Knee Extension Test (AKET) for hamstring flexibility
4. Quebec Back pain Disability Scale (QBPDS) to assess functional impairment |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/09/2025 |
| 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="1"
Months="0"
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
|
The introduction highlights that low back pain (LBP) is one of the most common global health issues, affecting up to 80% of people and causing disability, high healthcare costs, and reduced quality of life. Most cases (about 85%) are non-specific low back pain (NSLBP), meaning no clear underlying cause can be identified. Among the contributing factors, hamstring tightness and trunk muscle fatigue play an important role. The introduction then discusses two physiotherapy interventions: Mulligan Bent Leg Raise Technique (BLR): a manual therapy performed in a pain-free range, aiming to restore mobility, reduce pain, and improve hamstring flexibility. Muscle Energy Technique (MET): a patient-active method involving controlled muscle contractions against resistance, often used for lumbopelvic dysfunctions. Since evidence on the effectiveness of these approaches in NSLBP is limited, the study seeks to compare Mulligan BLR and MET in reducing hamstring tightness, pain, and functional disability in patients with acute NSLBP |