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

NCT05021718 | Completed

• 1 other identifier: LDH exercise
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Low back pain; Disc herniation; Strengthening exercise; ADL instructions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

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; Behavioral: Activities to daily living instructions

Control group (CG)

ACTIVE COMPARATOR

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; Other: Hot compression; Behavioral: Activities to daily living instructions

Interventions

Strengthening exercises OTHER

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

Intervention group (IG)

Pharmacological therapy DRUG

Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks

Control group (CG)

Hot compression OTHER

Hot moist compression from week 4 to week 6.

Control group (CG)

Activities to daily living instructions BEHAVIORAL

* Avoid forward bending. * Avoid heavy weightlifting. * Avoid prolong standing. * Avoid prolong sitting. * Use a plain firm bed. * Lie down in a supine position.

Control group (CG); Intervention group (IG)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 - 59 years.
• Clinically diagnosed LDH that was confirmed by MRI.
• Duration of the pain: ≥ 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS student

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 25, 2021
• Study Start: July 1, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 30, 2019
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)