| CTRI Number |
CTRI/2025/07/090632 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Structured exercise program and radial extracorporeal shockwave therapy with McKenzie method on pain intensity, sensitivity and quality in athletes with chronic low back pain |
|
Scientific Title of Study
|
Comparative effectiveness of a structured exercise program and radial extracorporeal shockwave therapy with McKenzie method on pain intensity, sensitivity and quality in athletes with chronic low back pain: a four-arm randomized 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 |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jannatul Ferdous Rikti |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01759196610 |
| Fax |
|
| Email |
jannatrikti192403@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suraiya Yesmin Sharna |
Dr. M R Khan Medical Centre |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
|
01786395080
sharnajust1019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group (McKenize method) |
This control group will perform the McKenzie method exercise alone for 6 weeks/18 sessions. Each session will begin with a five-minute warm-up on a stationary cycle. Then participants will perform exercises following the McKenzie method, including prone trunk extension with elbows supported (20-second hold, 3 sets), prone trunk extension with hands supported and elbows extended (10-second hold, 3 sets), and standing trunk extension (10-second hold, 3 sets) under the supervision of a certified physiotherapist. Finally, the exercise session will conclude with a five-minute breathing exercise and respiratory training as a cool-down. |
| Intervention |
Experimental group 1 (SEP+McKenzie) |
This group will receive a structured exercise programme (SEP) with the McKenzie method for 6 weeks/18 sessions. Each session will begin with a five-minute warm-up on a stationary cycle, followed by a stretching program targeting the hamstrings, iliopsoas, and back extensors using cat-cow and child pose stretches. Each stretch will be performed for 3 repetitions, with a 30-second hold per repetition. Subsequently, participants will perform a progressive core stability exercise, including pelvic backswept, crunches, glute bridges, bird-dogs, bear crawls, and contralateral arm lifting exercise. Then participants will perform exercises following the McKenzie method, including prone trunk extension with elbows supported (20-second hold, 3 sets), prone trunk extension with hands supported and elbows extended (10-second hold, 3 sets), and standing trunk extension (10-second hold, 3 sets). Finally, the exercise session will conclude with a five-minute breathing exercise and respiratory training as a cool-down. |
| Intervention |
Experimental group 2 (rESWT+McKenzie) |
This group will receive radial extracorporeal shockwave therapy (rESWT) with McKenzie method exercises for 6 weeks/18 sessions. Each session will begin with a five-minute warm-up on a stationary cycle. Participants will receive rESWT to the QL, piriformis, and gluteal muscles, using the parameters - 2000 shocks, 4 Hz, 0.1 mJ/mm². Then participants will perform exercises following the McKenzie method, including prone trunk extension with elbows supported (20-second hold, 3 sets), prone trunk extension with hands supported and elbows extended (10-second hold, 3 sets), and standing trunk extension (10-second hold, 3 sets). Finally, the exercise session will conclude with a five-minute breathing exercise and respiratory training as a cool-down. |
| Intervention |
Experimental group 3 (SEP+rESWT+McKenzie) |
Experimental group 3 (SEP+rESWT+McKenzie)
This group will receive a combination of a structured exercise programme (SEP), rESWT, and McKenzie method exercises for 6 weeks/18 sessions. Each session will begin with a five-minute warm-up on a stationary cycle, followed by a stretching program targeting the hamstrings, iliopsoas, and back extensors using cat-cow and child pose stretches. Each stretch will be performed for 3 repetitions, with a 30-second hold per repetition. Subsequently, participants will perform a progressive core stability exercise, including pelvic backswept, crunches, glute bridges, bird-dogs, bear crawls, and contralateral arm lifting. Participants will receive rESWT to the QL, piriformis, and gluteal muscles, using the parameters - 2000 shocks, 4 Hz, 0.1 mJ/mm². Then participants will perform exercises following the McKenzie method, including prone trunk extension with elbows supported (20-second hold, 3 sets), prone trunk extension with hands supported and elbows extended (10-second hold, 3 sets), and standing trunk extension (10-second hold, 3 sets). Finally, the exercise session will conclude with a five-minute breathing exercise and respiratory training as a cool-down. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Athletes with non-specific LBP with pain and symptoms persisting for more than 3 months and (2) visual analog scale of more than 3; (3) Athletes had to participate in level-I (jumping, pivoting, hard cutting like basketball, handball, soccer) or level-II sports (less jumping or hard cutting than level I, like volleyball, racket sports, martial arts, gymnastics) and training or playing five times per week. Athletes must participate in official competitions (state, national or international competitions). (4) athletes aged between 15 and 40 years; (5) pain radiating no further than the buttock (6) X-ray / MRI – normal findings. |
|
| ExclusionCriteria |
| Details |
(1) History of lumbar disc herniation or trauma; (2) Any neurological symptoms and disease; (3) previous back surgery, spinal tumors or infections; (4) Pregnant; (5) Athletes who are using analgesics, dietary supplementation and/or anabolic steroids will also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity (Numeric pain rating scale), Pain sensitivity (Pressure pain threshold), Pain quality (Short version of McGill pain questionnaire) |
At baseline, after week-3, week-6, week-12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability (Oswestry disability index), Quality of life (SF-36), Fear and avoidance (Fear avoidance beliefs questionnaire), Psychological distress (Depression anxiety stress scale-21) |
At baseline, after week-3, week-6, week-12 |
|
|
Target Sample Size
|
Total Sample Size="260"
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) |
25/07/2025 |
| 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) |
|
|
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
|
This study will investigate
the comparative effectiveness of four groups for chronic low back pain (LBP) in
athletes. Overall, include three types of interventions: a structured exercise
program (SEP), rESWT, and the McKenzie method. The study will be a 6-week, four-arm
randomized controlled trial targeting athletes aged 15-40 years, experiencing
non-specific LBP for more than three months. Primary outcomes include pain
intensity, pain sensitivity, and pain quality, measured by the Numeric Pain
Rating Scale, Pressure Pain Threshold, and McGill Pain Questionnaire. Secondary
outcomes include disability, quality of life, fear avoidance beliefs, and
psychological distress. The study aims to evaluate the efficacy of these
interventions in improving pain and functional outcomes, providing insights
into optimal treatment strategies for athletes with chronic LBP. |