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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Strengthening exercises
Pharmacological therapy
Hot compression
Activities to daily living instructions
Sponsored by
Chittagong Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Low back pain, Disc herniation, Strengthening exercise, ADL instructions

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chittagong Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group (IG)

Control group (CG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 22, 2021
Last Updated
August 24, 2021
Sponsor
Chittagong Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05021718
Brief Title
Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
Official Title
Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chittagong Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Low back pain, Disc herniation, Strengthening exercise, ADL instructions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (CG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Strengthening exercises
Intervention Description
Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
Intervention Type
Drug
Intervention Name(s)
Pharmacological therapy
Intervention Description
Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
Intervention Type
Other
Intervention Name(s)
Hot compression
Intervention Description
Hot moist compression from week 4 to week 6.
Intervention Type
Behavioral
Intervention Name(s)
Activities to daily living instructions
Intervention Description
Avoid forward bending. Avoid heavy weightlifting. Avoid prolong standing. Avoid prolong sitting. Use a plain firm bed. Lie down in a supine position.
Primary Outcome Measure Information:
Title
Changes in perceived pain intensity
Description
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.
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.
Secondary Outcome Measure Information:
Title
Changes in the range of hip flexion during straight leg raising test
Description
The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chittagong Medical College Hospital
City
Chittagong
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

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

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