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Completed

NCT Number: NCT05021718

Strengthening Exercise and Activities of Daily Living Instructions for 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.

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Key information

Conditions

Lumbar Disc Herniation Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chittagong Medical College Hospital

Chittagong, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Pharmacological therapy

Drug

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

Hot compression

Other

Hot moist compression from week 4 to week 6.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chittagong Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2021
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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