Lumbar RadiculopathyNCT04427423
Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
A study testing physical therapy treatment in people with Lumbar Radiculopathy, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2020to 25 Jan 2021
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of lumbar radiculopathy
- Age limit 30-50 years
- Both males and females
- Pain history more than 12 weeks but less than one year
- Patient having lumbar disc bulge at maximum two adjacent levels
Who cannot join
- Any type of tumor and infection in the spine
- Spondylolisthesis at L4- L5, L5-S1
- Fracture of the lumbar spine
- Sciatica other than lumbar region (piriformis syndrome)
- Acute cardiopulmonary conditions
- Morbid obesity (BMI \> 30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.
This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.
Read the detailed description
In positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar mechanical traction.
The spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. For further distraction both hips are flexed until movement is noted at the spinal level needing traction.
Further, distraction applied by rotating upper trunk to opposite side of pain.
Stabilization exercises are mainly used for the stability of joints and for improving muscle strength.
The first step of lumbar stabilization exercises are to maintain functional back positions during all activities. The second step is to improve strength and endurance of the core muscles.
- Conditions
- Lumbar Radiculopathy
- Being tested
- physical therapy treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy treatmentOther
the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
| Study group | Role | What they receive |
|---|---|---|
| Positional Distraction plus Stabilization Exercise group | Experimental | The treatment group will receive positional distraction with stabilization exercises Receives: Other: physical therapy treatment |
| Stabilization Exercise group | Active comparator | control group will be treated with stabilization exercises only. Receives: Other: physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Pain intensity at 8 weeks
The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).
Measured: All the subjects were assessed before and after 8 weeks of treatment.
Change from baseline Disability at 8 weeks
The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.
Measured: All the subjects were assessed before and after 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start10 Apr 2020
- Primary completion12 Dec 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IPMR DUHS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427423
- Sponsor's protocol ID
- SKhan
- Status last verified
- Feb 2021
- First submitted
- 27 Apr 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan S, Hasnain F, Soomro RR, Rehmani A. Comparison of positional distraction with stabilisation exercises versus stabilisation exercises alone in the management of lumbar radiculopathy: A randomized controlled-trial. J Pak Med Assoc. 2024 Jan;74(1):5-9. doi: 10.47391/JPMA.6540.
PubMed 38219156
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.
- ClinicalTrials.gov ID
- NCT04427423
- Acronym / sponsor ID
- SKhan
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 11 Jun 2020 (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.
This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.
Detailed description
In positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar mechanical traction.
The spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. For further distraction both hips are flexed until movement is noted at the spinal level needing traction.
Further, distraction applied by rotating upper trunk to opposite side of pain.
Stabilization exercises are mainly used for the stability of joints and for improving muscle strength.
The first step of lumbar stabilization exercises are to maintain functional back positions during all activities. The second step is to improve strength and endurance of the core muscles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
| Arm | Type | Receives |
|---|---|---|
| Positional Distraction plus Stabilization Exercise group | Experimental | Other: physical therapy treatmentThe treatment group will receive positional distraction with stabilization exercises |
| Stabilization Exercise group | Active comparator | Other: physical therapy treatmentcontrol group will be treated with stabilization exercises only. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of lumbar radiculopathy
- Age limit 30-50 years
- Both males and females
- Pain history more than 12 weeks but less than one year
- Patient having lumbar disc bulge at maximum two adjacent levels
Key exclusion criteria (6 listed)
- Any type of tumor and infection in the spine
- Spondylolisthesis at L4- L5, L5-S1
- Fracture of the lumbar spine
- Sciatica other than lumbar region (piriformis syndrome)
- Acute cardiopulmonary conditions
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 |
|---|---|---|
| physical therapy treatmentthe experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only. | Other | Positional Distraction plus Stabilization Exercise group, Stabilization Exercise group |
Primary outcome
Change from baseline Pain intensity at 8 weeks
Time frame: All the subjects were assessed before and after 8 weeks of treatment.
The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).
Change from baseline Disability at 8 weeks
Time frame: All the subjects were assessed before and after 8 weeks of treatment.
The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.
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 23 Feb 2021.
- Derived from this study: PubMed 38219156Khan S, Hasnain F, Soomro RR, Rehmani A. Comparison of positional distraction with stabilisation exercises versus stabilisation exercises alone in the management of lumbar radiculopathy: A randomized controlled-trial. J Pak Med Assoc. 2024 Jan;74(1):5-9. doi: 10.47391/JPMA.6540.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
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.
IPMR DUHS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy treatment in people with Lumbar Radiculopathy, run by Dow University of Health Sciences at 1 site in Pakistan.
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 5 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 23 Feb 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 Pakistan. 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?
Change from baseline Pain intensity at 8 weeks (time frame: All the subjects were assessed before and after 8 weeks of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427423, which also lists 1 linked publication.
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 23 Feb 2021.