| CTRI Number |
CTRI/2025/07/089927 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Test Whether Core Strengthening and Stretching Exercises Help People with Spondylolisthesis |
|
Scientific Title of Study
|
Effectiveness of Abdominal Hollowing and Piriformis Stretching Exercises in Spondylolisthesis Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganesh Dey |
| Designation |
Lecturer,Department of Physiotherapy,Bangladesh Health Professions Institute |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Department of Physiotherapy,Bangladesh Health Professions Institute
1343
Other |
| Phone |
01942764390 |
| Fax |
|
| Email |
physioganesh27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mohammad Anwar Hossain |
| Designation |
Professor, Dept. of Physiotherapy |
| Affiliation |
Bangladesh Health Professions Institute (BHPI), CRP |
| Address |
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka.
1343
Other |
| Phone |
01753559949 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mohammad Anwar Hossain |
| Designation |
Professor, Dept. of Physiotherapy |
| Affiliation |
Bangladesh Health Professions Institute (BHPI), CRP |
| Address |
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka.
1343
Other |
| Phone |
01753559949 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,Bangladesh Health Professions Institute, Savar, Dhaka – 1343, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Ganesh Dey |
| Address |
Department of Physiotherapy,Bangladesh Health Professions Institute, Savar, Dhaka – 1343, Bangladesh |
| Type of Sponsor |
Other [Self-Funded] |
|
|
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 Ganesh Dey |
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka |
Room no: 201, Dept of Physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343
|
01942764390
physioganesh27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of BHPI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abdominal Hollowing Exercise and Piriformis Stretching Exercise |
The intervention involves abdominal hollowing and piriformis stretching exercises for patients with spondylolisthesis. The abdominal hollowing exercise aims to strengthen the deep abdominal muscles, particularly the transversus abdominis, which plays a key role in spinal stabilization. This exercise is performed in two positions: crook lying and standing, with the participant drawing the belly button inward without tilting the pelvis, holding for 5-10 seconds, and repeating 10 times. The piriformis stretching exercise targets the piriformis muscle to alleviate tightness and improve flexibility. It is performed by crossing one leg over the other and gently pulling the knee toward the opposite shoulder, holding for 10 seconds, and repeating 10 times. The exercises are done once a day, 3-4 times a week for six weeks. |
| Comparator Agent |
Standard Physiotherapy Treatment |
The control group receives standard physiotherapy treatment, including general exercises for stretching, strengthening, and lumbar flexion. The treatment focuses on improving flexibility, reducing muscle tension, and strengthening core and lower back muscles to improve spinal stability. The control group also receives postural education, providing guidance on proper posture during sitting, standing, and walking to prevent further strain. The treatment is administered 3-4 times a week for six weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants eligible for the study must meet the following criteria:
Both male and female patients, regardless of age, diagnosed with spondylolisthesis through radiological examination of the lumbar spine (L1 to L5 segment).
Patients experiencing low back pain with or without leg pain, regardless of whether the condition is acute or chronic.
Patients with reduced functional capacity due to spondylolisthesis, as assessed by standard disability questionnaires.
Participants willing to provide informed consent and participate in the full course of the study. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they meet any of the following criteria:
History of spinal surgery, especially those with spinal fixation, as they may not respond to physiotherapy.
Any prior exercise therapy for back pain in the last 2 months, as this may affect the response to the interventions.
Presence of any neurological disorders that could interfere with participation or the treatment outcomes.
Patients with conditions other than spondylolisthesis causing back pain.
Pregnant women, as certain exercises may be contraindicated during pregnancy.
Diagnosed with spinal tumors, tuberculosis, or other systemic diseases contraindicated for physiotherapy.
Severe psychological disorders that may hinder the patient’s ability to comply with the exercise regimen.
Lack of cooperation, motivation, or dissatisfaction with the treatment protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Intensity: Measured using the Dallas Pain Questionnaire (DPQ) at baseline and post-intervention (6 weeks).
Functional Disability: Assessed with the Oswestry Disability Index (ODI) at baseline and post-intervention (6 weeks).
Kinesiophobia (Fear of Movement): Measured using the Tampa Scale for Kinesiophobia (TSK) at baseline and post-intervention (6 weeks). |
6 weeks of treatment (18 sessions). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Spinal Mobility: Measured by range of motion tests (not detailed in the thesis, but typically assessed during the intervention period).
Quality of Life: Measured through general health and well-being questionnaires, if applicable (not explicitly mentioned, but often included in such trials). |
6 weeks of treatment (18 sessions). |
|
|
Target Sample Size
|
Total Sample Size="60"
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) |
01/07/2025 |
| 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 - NO
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of abdominal hollowing and piriformis stretching exercises in managing symptoms of spondylolisthesis. The randomized controlled trial will involve 60 participants, who will be randomly assigned to either an experimental group receiving the exercises or a control group receiving standard physiotherapy treatment. The primary outcomes of the study include pain intensity, functional disability, and kinesiophobia. Data will be collected at baseline and after 6 weeks of intervention. The goal is to assess whether these exercises can significantly reduce pain, improve mobility, and decrease fear of movement in patients with spondylolisthesis. |