Disc DiseaseNCT06548334
The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial
A study testing Advanced Physiotherapy and Conventional Physiotherapy Techniques in people with Disc Disease, run by Superior University at 1 site in Pakistan.
Trial summary
Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disc Disease
- What is being tested?
- Advanced Physiotherapy and Conventional Physiotherapy Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a diagnosis of Disc bulge confirmed by MRI.
- Between 18 and 65 years of age.
- Chronic low back pain from the last 3 months
- A stable treatment environment that allows intervention.
- Ability to understand and follow course directions.
- Willingness to give informed consent
Who cannot join
- Spondylolisthesis
- Spondylosis
- Vertebral fracture
- Lack of ava
- Further research interventions.
- Unstable medical condition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nemat Hospital & Heart Center, Manga Mandi
Lahore, Punjab Province
About this study
Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.
Read the detailed description
this study was proposed to evaluate its efficacy in improving accessary lower limb flexibility and reducing functional disability and pain management. To provide evidence about its effectiveness and help with clinical practice, this study aimed to improve patient outcomes in subjects having lumbar disc bulges.
- Conditions
- Disc Disease
- Being tested
- Advanced Physiotherapy, Conventional Physiotherapy Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced PhysiotherapyCombination product
The physiotherapist used the regression techniques for 1 hour of session 2 times for 8 weeks. The caudal component involved the spinous process of the treated segment touching the therapist's hand and not applying force as though mobilising the segment at grade 2. These were applied if there is a suspected case of a posterolateral disc prolapse where the aim is to increase the diameter of the foramen and decrease the tension exerted on the nerve root. Applied posteroanterior was used to distract the anterior intervertebral end plate and to approximate the posterior end plates so as to pull back the protruded nuclear material by creating a negative pressure.
Conventional Physiotherapy TechniquesOther
In traditional physiotherapy, the patient underwent two sessions per week for eight weeks. Each session lasted one hour and included 20minutes of TENS treatment. The flexibility exercises consisted of hamstring stretches and single and double knee-to-chest stretches. The strengthening exercises were partial sit-ups, quadruped lifts, and double leg hold; pelvic tilts were performed with 10-15 repetitions, each held for 20-30 seconds and repeated three times.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Physiotherapy | Experimental | Not described Receives: Combination Product: Advanced Physiotherapy |
| Conventional Physiotherapytechniques | Active comparator | Not described Receives: Other: Conventional Physiotherapy Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris disability questionnaire
The Roland-Morris low back pain and disability questionnaire (RMD) was utilised to evaluate the quality of life prior to and following the completion of the treatment. This questionnaire has demonstrated strong validity and reliability. The score is measured on a scale of 0 to 24, and percentage scores were calculated for each participant. Greater scores indicate a greater level of disabilities. Its sensitivity is 95%, and its specificity is 69%.
Measured: 12 Months
Straight Leg Raise
The normal angle for an SLR is from 0-35 degrees, which signifies the least amount of strain. Stretched from 35-70 degrees, sciatic nerve root stretching is achieved, and possible problems such as herniated disc or radiculopathy may be evidenced. 70- 90 degrees reflect highest normal flexibility: it may be related to hip joint pathology or some other conditions which are not a result of nerve injury. During both the first evaluation and the final therapy, the SLR was assessed using a digital inclinometer (clinometer) installed on a Techno Camon 20 Android phone. The digital inclinometer has been found to exhibit high levels of reliability and validity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548334
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/736
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06548334
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/736
- Conditions
- Disc Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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 bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.
Detailed description
this study was proposed to evaluate its efficacy in improving accessary lower limb flexibility and reducing functional disability and pain management. To provide evidence about its effectiveness and help with clinical practice, this study aimed to improve patient outcomes in subjects having lumbar disc bulges.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Physiotherapy | Experimental | Combination Product: Advanced Physiotherapy |
| Conventional Physiotherapytechniques | Active comparator | Other: Conventional Physiotherapy Techniques |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with a diagnosis of Disc bulge confirmed by MRI.
- Between 18 and 65 years of age.
- Chronic low back pain from the last 3 months
- A stable treatment environment that allows intervention.
- Ability to understand and follow course directions.
Key exclusion criteria (6 listed)
- Spondylolisthesis
- Spondylosis
- Vertebral fracture
- Lack of ava
- Further research interventions.
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 |
|---|---|---|
| Advanced PhysiotherapyThe physiotherapist used the regression techniques for 1 hour of session 2 times for 8 weeks. The caudal component involved the spinous process of the treated segment touching the therapist's hand and not applying force as though mobilising the segment at grade 2. These were applied if there is a suspected case of a posterolateral disc prolapse where the aim is to increase the diameter of the foramen and decrease the tension exerted on the nerve root. Applied posteroanterior was used to distract the anterior intervertebral end plate and to approximate the posterior end plates so as to pull back the protruded nuclear material by creating a negative pressure. | Combination product | Advanced Physiotherapy |
| Conventional Physiotherapy TechniquesIn traditional physiotherapy, the patient underwent two sessions per week for eight weeks. Each session lasted one hour and included 20minutes of TENS treatment. The flexibility exercises consisted of hamstring stretches and single and double knee-to-chest stretches. The strengthening exercises were partial sit-ups, quadruped lifts, and double leg hold; pelvic tilts were performed with 10-15 repetitions, each held for 20-30 seconds and repeated three times. | Other | Conventional Physiotherapytechniques |
Primary outcome
Roland Morris disability questionnaire
Time frame: 12 Months
The Roland-Morris low back pain and disability questionnaire (RMD) was utilised to evaluate the quality of life prior to and following the completion of the treatment. This questionnaire has demonstrated strong validity and reliability. The score is measured on a scale of 0 to 24, and percentage scores were calculated for each participant. Greater scores indicate a greater level of disabilities. Its sensitivity is 95%, and its specificity is 69%.
Straight Leg Raise
Time frame: 12 months
The normal angle for an SLR is from 0-35 degrees, which signifies the least amount of strain. Stretched from 35-70 degrees, sciatic nerve root stretching is achieved, and possible problems such as herniated disc or radiculopathy may be evidenced. 70- 90 degrees reflect highest normal flexibility: it may be related to hip joint pathology or some other conditions which are not a result of nerve injury. During both the first evaluation and the final therapy, the SLR was assessed using a digital inclinometer (clinometer) installed on a Techno Camon 20 Android phone. The digital inclinometer has been found to exhibit high levels of reliability and validity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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 Advanced Physiotherapy and Conventional Physiotherapy Techniques in people with Disc Disease, run by Superior University 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 6 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
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?
Roland Morris disability questionnaire (time frame: 12 Months). 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?
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 12 Aug 2024.