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

NCT ID: NCT05021718

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group (IG)

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.

Group Type EXPERIMENTAL

Strengthening exercises

Intervention Type OTHER

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

Activities to daily living instructions

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Pharmacological therapy

Intervention Type DRUG

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

Hot compression

Intervention Type OTHER

Hot moist compression from week 4 to week 6.

Activities to daily living instructions

Intervention Type BEHAVIORAL

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

Interventions

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Strengthening exercises

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

Intervention Type OTHER

Pharmacological therapy

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

Intervention Type DRUG

Hot compression

Hot moist compression from week 4 to week 6.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chittagong Medical College

OTHER

Sponsor Role lead

Responsible Party

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MD Imam Shahriar

FCPS student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chittagong Medical College Hospital

Chittagong, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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LDH exercise

Identifier Type: -

Identifier Source: org_study_id

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