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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021718
• Other study ID #: LDH exercise
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2021
• Source: Chittagong Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 30, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Other:
• Strengthening exercises
Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.

Drug:
• Pharmacological therapy
Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks

Other:
• Hot compression
Hot moist compression from week 4 to week 6.

Behavioral:
• Activities to daily living instructions
Avoid forward bending. Avoid heavy weightlifting. Avoid prolong standing. Avoid prolong sitting. Use a plain firm bed. Lie down in a supine position.

Locations

Country	Name	City	State
Bangladesh	Chittagong Medical College Hospital	Chittagong

Sponsors (1)

Lead Sponsor	Collaborator
Chittagong Medical College

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.