Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Other: Strengthening exercises
* Drug: Pharmacological therapy
* Other: Hot compression
* Behavioral: Activities to daily living instructions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (IG)<br>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. | Other: Strengthening exercises<br>* Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.<br>Behavioral: Activities to daily living instructions<br>* Avoid forward bending. Avoid heavy weightlifting. Avoid prolong standing. Avoid prolong sitting. Use a plain firm bed. Lie down in a supine position.<br>|
| Active Comparator: Control group (CG)<br>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. | Drug: Pharmacological therapy<br>* Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks<br>Other: Hot compression<br>* Hot moist compression from week 4 to week 6.<br>Behavioral: Activities to daily living instructions<br>* Avoid forward bending. Avoid heavy weightlifting. Avoid prolong standing. Avoid prolong sitting. Use a plain firm bed. Lie down in a supine position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perceived pain intensity | 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. | 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 | The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry. | Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Disc herniation, Strengthening exercise, ADL instructions