Lumbar RadiculopathyNCT05356689
Patient Specific 3-Dimensional And 2-Dimensional Lumbar Traction In Patients With Lumbar Radiculopathy
A study testing mechanical traction in people with Lumbar Radiculopathy and Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study will be comparative effectiveness of the 2d and 3d lumbar traction on pain and functional disability in lumbar radiculopathy. This study will be useful for the physiotherapists to know which traction equipment will be more effective for the treatment of the lumbar radiculopathy Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy, Radiculopathy
- What is being tested?
- mechanical traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Mar 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both male \& female participants
- Age group between 30 to 65 yrs.
- Participants having chronic radiating pain in one or both legs will be included.
- Patients having history of low back ache for 30 days in last six months.
- Minimum of 25 score out of 100, on low back pain index
- Participants suffering from intervertebral disc prolapse diagnosed by Orthopedic Surgeon or Experienced Physiotherapist
Who cannot join
- Participants having contraindication to spinal manipulative therapy. 18
- Participants having disorders of autoimmune nature,
- Participants having neurodegenerative diseases,
- Participants having organic referred pain,
- Participants having pregnancy,
- participant with history of back surgery
Show all 10Show fewer
- History of cancer /metastasis
- participant having medications periodically
- participant suffering from psychological conditions
- participants with history of inflammatory joint disease arthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Life Line Hospital
Lahore, Punjab Province, 38000
saba Rafique, 03034045433, saba.rafique@riphah.edu
Hassan Mehmood, MSPT-OM
About this study
Official title: Comparative Effects Of Patient Specific 3-Dimensional And 2-Dimensional Lumbar Traction On Pain And Functional Disability In Patients With Lumbar Radiculopathy
The aim of study will be comparative effectiveness of the 2d and 3d lumbar traction on pain and functional disability in lumbar radiculopathy. This study will be useful for the physiotherapists to know which traction equipment will be more effective for the treatment of the lumbar radiculopathy
Read the detailed description
In one studied the effect of patient-specific three-dimensional lumbar traction on pain and functional disability in individuals with lumbar intervertebral disc prolapse. Twenty-five participants (age range: 34-67 years) diagnosed with lumbar intervertebral disc prolapse were included in this study. Patient-specific three-dimensional lumbar traction was given as three sessions per week for the duration of one month. All participants completed a 10-cm visual analog pain scale and pain pressure threshold to assess pain and the Oswestry disability index to assess the functional disability. Twelve sessions of patient-specific three-dimensional lumbar traction promoted a reduction in pain and improvement in functional disability among subjects with lumbar intervertebral disc prolapse.Another studied to evaluate the effectiveness of traction in improving low back pain, functional outcome, and disk morphology in patients with herniated intervertebral disks. They included randomized control trials which involved adult patients with low back pain associated with herniated disk confirmed by magnetic resonance imaging or computed tomography, compared lumbar traction to sham or no traction, and provided quantitative measurements of pain and function before and after intervention. Methodological quality was assessed using the physiotherapy evidence database (Pedro) scale and Cochrane risk of bias assessment. Compared with sham or no traction, lumbar traction exhibited significantly more pain reduction and functional improvements in the short term, but not in the long term.
In Pakistan most of the physiotherapists used the two-dimensional traction bed for lumbar traction. There is insufficient study on Three-dimensional Traction unit. And there is no literature review is available on comparison of the 2d and 3d traction. To the best of researcher's knowledge, it can be concluded that insufficient literature is available on th
- Conditions
- Lumbar Radiculopathy, Radiculopathy
- Being tested
- mechanical traction
- Keywords
- radiculopathy, lumber
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical tractionOther
Also called core strengthening
Group A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction.
| Study group | Role | What they receive |
|---|---|---|
| traditional physiotherapy | Experimental | Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction. Receives: Other: mechanical traction |
| 3- 2dimensional lumbar traction | Experimental | Group A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. Receives: Other: mechanical traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain". NPRS have shown high test-retest reliability (r = 0.96 and 0.95, respectively)
Measured: 10 months
Oswestry Disability Index (ODI)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools The final score/index ranges from 0-100.
A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Mar 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- saba Rafique, ppdpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356689
- Sponsor's protocol ID
- REC/Lhr/22/0126 Hassan
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
PubMed 17445735Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
PubMed 22543563Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
PubMed 31788391Cheng YH, Hsu CY, Lin YN. The effect of mechanical traction on low back pain in patients with herniated intervertebral disks: a systemic review and meta-analysis. Clin Rehabil. 2020 Jan;34(1):13-22. doi: 10.1177/0269215519872528. Epub 2019 Aug 28.
PubMed 31456418
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Patient Specific 3-Dimensional And 2-Dimensional Lumbar Traction On Pain And Functional Disability In Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05356689
- Acronym / sponsor ID
- REC/Lhr/22/0126 Hassan
- Conditions
- Lumbar Radiculopathy, Radiculopathy
- Keywords
- radiculopathy, lumber
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 2 May 2022 (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.
The aim of study will be comparative effectiveness of the 2d and 3d lumbar traction on pain and functional disability in lumbar radiculopathy. This study will be useful for the physiotherapists to know which traction equipment will be more effective for the treatment of the lumbar radiculopathy
Detailed description
In one studied the effect of patient-specific three-dimensional lumbar traction on pain and functional disability in individuals with lumbar intervertebral disc prolapse. Twenty-five participants (age range: 34-67 years) diagnosed with lumbar intervertebral disc prolapse were included in this study. Patient-specific three-dimensional lumbar traction was given as three sessions per week for the duration of one month. All participants completed a 10-cm visual analog pain scale and pain pressure threshold to assess pain and the Oswestry disability index to assess the functional disability. Twelve sessions of patient-specific three-dimensional lumbar traction promoted a reduction in pain and improvement in functional disability among subjects with lumbar intervertebral disc prolapse.Another studied to evaluate the effectiveness of traction in improving low back pain, functional outcome, and disk morphology in patients with herniated intervertebral disks. They included randomized control trials which involved adult patients with low back pain associated with herniated disk confirmed by magnetic resonance imaging or computed tomography, compared lumbar traction to sham or no traction, and provided quantitative measurements of pain and function before and after intervention. Methodological quality was assessed using the physiotherapy evidence database (Pedro) scale and Cochrane risk of bias assessment. Compared with sham or no traction, lumbar traction exhibited significantly more pain reduction and functional improvements in the short term, but not in the long term.
In Pakistan most of the physiotherapists used the two-dimensional traction bed for lumbar traction. There is insufficient study on Three-dimensional Traction unit. And there is no literature review is available on comparison of the 2d and 3d traction. To the best of researcher's knowledge, it can be concluded that insufficient literature is available on th
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional physiotherapy | Experimental | Other: mechanical tractionCommon Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction. |
| 3- 2dimensional lumbar traction | Experimental | Other: mechanical tractionGroup A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both male \& female participants
Key exclusion criteria (10 listed)
- Participants having contraindication to spinal manipulative therapy. 18
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 |
|---|---|---|
| mechanical tractionAlso: core strengtheningGroup A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction. | Other | 3- 2dimensional lumbar traction, traditional physiotherapy |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 10 months
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain". NPRS have shown high test-retest reliability (r = 0.96 and 0.95, respectively)
Oswestry Disability Index (ODI)
Time frame: 10 months
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 17445735Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
- Background: PubMed 22543563Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
- Background: PubMed 31788391Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
- Background: PubMed 31456418Cheng YH, Hsu CY, Lin YN. The effect of mechanical traction on low back pain in patients with herniated intervertebral disks: a systemic review and meta-analysis. Clin Rehabil. 2020 Jan;34(1):13-22. doi: 10.1177/0269215519872528. Epub 2019 Aug 28.
- 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.
saba Rafique, ppdpt principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical traction in people with Lumbar Radiculopathy and Radiculopathy, run by Riphah International 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 10 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 2 May 2022. 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?
Contact imran Amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (time frame: 10 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?
On the ClinicalTrials.gov record for NCT05356689, which also lists 4 linked publications.
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 2 May 2022.