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

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Other: Strengthening exercises; Drug: Pharmacological therapy; Behavioral: Activities to daily living instructions; Other: Hot compression

• Registration Number: NCT05021718
• Lead Sponsor: Chittagong Medical College

Brief Summary

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

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 Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (IG)	Strengthening exercises	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.
Intervention group (IG)	Activities to daily living instructions	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.
Control group (CG)	Pharmacological therapy	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.
Control group (CG)	Hot compression	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.
Control group (CG)	Activities to daily living instructions	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.

Primary Outcome Measures

Name	Time	Method
Changes in perceived pain intensity	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the range of hip flexion during straight leg raising test	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.

Trial Locations

Locations (1)

Chittagong Medical College Hospital; 🇧🇩 Chittagong, Bangladesh