Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation
Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain (LBP) associated with radiating leg pain. Conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of LDH.
This randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (ADLIs) to reduce pain intensity in patients with LDH.
Study Overview
Status
Conditions
Detailed Description
A total of 70 patients with LDH were randomly allocated to either the intervention group (IG) or the control group (CG). Patients in IG received different back and hip strengthening exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. In addition, the patients in both groups were instructed to follow the ADLIs during the intervention and at least 3 months after the intervention.
The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chittagong, Bangladesh
- Chittagong medical College hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18 - 59 years.
- Clinically diagnosed LDH that was confirmed by MRI.
- Duration of the pain: ≥ 3 months
Exclusion Criteria:
- Painful spinal deformity
- Cauda equina syndrome
- Progressive neurological signs and/or muscle-wasting
- History of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours.
- Treated with epidural injections.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (IG)
A total of 35 patients in IG received different back and hip strengthening exercises five times a week for six weeks.
They were also instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
|
Back and hip strengthening exercises.
The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
|
|
Active Comparator: Control group (CG)
The remaining 35 patients were allocated to CG.
The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks.
Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
|
Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
Hot moist compression from week 4 to week 6.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perceived pain intensity
Time Frame: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
|
Visual analog scale (VAS) score: Patients were asked to rate their perceived pain on a 0-to-10-point scale, where 0 indicated no pain at all and 10 indicated the most severe imaginable pain.
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Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the range of hip flexion during straight leg raising test
Time Frame: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
|
The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry.
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Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LDH exercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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