Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05021718
Other study ID # LDH exercise
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05277818 - Post-marketing Clinical Follow-up of the Medical Device DIVA®
Recruiting NCT05467072 - PMCFU of an Annular Closure System
Withdrawn NCT03252691 - Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Withdrawn NCT01622413 - Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy N/A
Completed NCT04329598 - Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia N/A
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Completed NCT04073095 - Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery N/A
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Active, not recruiting NCT05613179 - Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Recruiting NCT05663437 - Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT05999253 - Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
Recruiting NCT03002207 - Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation N/A
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Completed NCT05003726 - Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation N/A
Completed NCT05556538 - The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
Not yet recruiting NCT04083703 - Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse N/A
Completed NCT03832036 - The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation N/A
Not yet recruiting NCT05584774 - Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty N/A