Lumbar Disc HerniationNCT05021718
Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
A study testing Strengthening exercises, Pharmacological therapy and Hot compression in people with Lumbar Disc Herniation, run by Chittagong Medical College at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Strengthening exercises, Pharmacological therapy and Hot compression
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 59 years.
- Clinically diagnosed LDH that was confirmed by MRI.
- Duration of the pain: ≥ 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in 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.
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Strengthening exercises, Pharmacological therapy, Hot compression, Activities to daily living instructions
- Keywords
- Low back pain, Disc herniation, Strengthening exercise, ADL instructions
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercisesOther
Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
Pharmacological therapyDrug
Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
Hot compressionOther
Hot moist compression from week 4 to week 6.
Activities to daily living instructionsBehavioural
- Avoid forward bending.
- Avoid heavy weightlifting.
- Avoid prolong standing.
- Avoid prolong sitting.
- Use a plain firm bed.
- Lie down in a supine position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pharmacological therapy; Other: Hot compression; Behavioral: Activities to daily living instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry.
Measured: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jul 2018
- Primary completion15 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD Imam Shahriar, Chittagong Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021718
- Sponsor's protocol ID
- LDH exercise
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05021718
- Acronym / sponsor ID
- LDH exercise
- Conditions
- Lumbar Disc Herniation
- Keywords
- Low back pain, Disc herniation, Strengthening exercise, ADL instructions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Other: Strengthening exercises, Behavioral: Activities to daily living instructionsA 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. |
| Control group (CG) | Active comparator | Drug: Pharmacological therapy, Other: Hot compression, Behavioral: Activities to daily living instructionsThe 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 - 59 years.
- Clinically diagnosed LDH that was confirmed by MRI.
- Duration of the pain: ≥ 3 months
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening exercisesBack and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects. | Other | Intervention group (IG) |
| Pharmacological therapyNaproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks | Drug | Control group (CG) |
| Hot compressionHot moist compression from week 4 to week 6. | Other | Control group (CG) |
| 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. | Behavioural | Control group (CG), Intervention group (IG) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercises, Pharmacological therapy and Hot compression in people with Lumbar Disc Herniation, run by Chittagong Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.