- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708781
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
November 21, 2023 updated by: Hashim Ahmed, Najran University
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises on Pain, Muscle Strength, Endurance, and Functional Disability in Patients With Chronic Non-specific Low Back Pain. a Randomized Comparative Study
The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be based on a three-arm parallel group randomized control design.
Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India.
Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study.
All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uttar Pardesh
-
Lucknow, Uttar Pardesh, India
- Integral University Hospital
-
-
-
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Najran
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Najrān, Najran, Saudi Arabia, 1988
- Hashim Ahmed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 20-50 years
- chronic low back pain (>3 months),
Exclusion Criteria:
- Participants with low back pain related to cancer,
- infection,
- inflammatory arthropathy,
- high-velocity trauma,
- fracture
- low back pain associated with severe or progressive neurological deficits trauma
- pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CSE Group
in addition to Conventional treatment, core strengthening exercise were given
|
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
|
|
Experimental: IDBE Group
in addition to Conventional treatment, intensive dynamic back exercise were given
|
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
|
|
Active Comparator: Control Group
Conventional Treatment
|
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 6 Weeks
|
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
|
6 Weeks
|
|
functional Limitation
Time Frame: 6 Weeks
|
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
|
6 Weeks
|
|
Muscle Endurance
Time Frame: 6 Weeks
|
Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test.
The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hashim Ahmed, PhD, Najran University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2022
Primary Completion (Actual)
August 17, 2023
Study Completion (Actual)
September 28, 2023
Study Registration Dates
First Submitted
January 20, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (Actual)
February 1, 2023
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IE/IIMS&R/2022/43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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