Non-specific Low Back PainNCT06812338
Effects of Different Positions on Mechanical Traction Outcome
A study testing mechanical traction in people with Non-specific Low Back Pain and Lumbar Traction, run by Prince Sattam Bin Abdulaziz University.
Trial summary
Our primary purpose for this study is to investigate the effect of different positions during traction on pain, function, and range of motion in adults with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-specific Low Back Pain, Lumbar Traction
- What is being tested?
- mechanical traction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult 18-65 years of age
- Non specific LBP persisted for more than 12 weeks
- At least 4/10 on NPRS
Who cannot join
- Vertebral fractures
- Axial spondylarthritis
- Aauda equina syndrome
- Radicular pain
- Radiculopathy
- Spinal stenosis
Show all 10Show fewer
- Spinal surgeries
- Malignancy
- Pregnancy
- Inflammatory or infectious cases of LBP
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Different Positions During Traction on Pain, Function, and Range of Motion in Adults with Non-specific Low Back Pain
Our primary purpose for this study is to investigate the effect of different positions during traction on pain, function, and range of motion in adults with non-specific low back pain.
- Conditions
- Non-specific Low Back Pain, Lumbar Traction
- Being tested
- mechanical traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical tractionDevice
Participants will receive traction therapy as follows: force will start at 25% of Body weight, gradually increasing until the tolerance for pulling is reached with maximum of 50% of body weight. The session will be 15 minutes long (1min for acceleration, 13 min application, 1min deceleration); it will be intermittent with ratio of 30 s on and 10s off
| Study group | Role | What they receive |
|---|---|---|
| Supine Participants | Active comparator | Participants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90° Receives: Device: mechanical traction |
| Prone Participants | Active comparator | will lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis Receives: Device: mechanical traction |
| Side-lying Participants | Active comparator | will lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between their knees Receives: Device: mechanical traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) Arabic version
assesses the impact of back pain on daily life across 10 sections. Each section covers different activities and aspects of daily living. The responses are scored from 0 (no impact) to 5 (maximum impact), with higher scores indicating greater disability
Measured: from baseline to the end of the 6th week
Secondary outcomes (3)
International Physical Activity Questionnaire (IPAQ) arabic version
the questionnaire includes questions about various domains of activity, such as job-related activity, transportation, housework, and leisure-time physical activity
Measured: from baseline to the end of the 6th week
Numerical pain rating scale (NPRS)
An 11-point scale that start at 0 (no pain) to 10 (worst imaginable pain)
Measured: from baseline to the end of the 6th week
Finger-to-floor test (FFT)
Participants will be asked to bend forward as much as possible, the distance between the tip of the middle finger and the platform is measured in Cm using a measurement tape.
Measured: from baseline to the end of the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies 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
- Model description
- It will be a triple-armed Randomized control trial, 30 subject will be recruited and randomly allocated into the three groups (supine, prone, and side-lying) using sealed envelope method, same treatment will be delivered with difference in positioning only, Supine Participants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90°, Prone Participants will lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis. Side-lying Participants will lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between his knees.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mshari Saleh Alghadier, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812338
- Sponsor's protocol ID
- RHPT/024/020
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon request through the principal investigator's email.
Publications
Beattie PF, Nelson RM, Michener LA, Cammarata J, Donley J. Outcomes after a prone lumbar traction protocol for patients with activity-limiting low back pain: a prospective case series study. Arch Phys Med Rehabil. 2008 Feb;89(2):269-74. doi: 10.1016/j.apmr.2007.06.778.
PubMed 18226650Tanovic E, Celik D, Omerovic D, Zovko Omeragic V, Jaganjac A, Konjo H, Rovcanin E, Omerovic H. Intermittent traction therapy in the treatment of chronic low back pain. Med Glas (Zenica). 2021 Feb 1;18(1):158-163. doi: 10.17392/1252-21.
PubMed 33269579Yorkin M, Spaccarotella K, Martin-Biggers J, Quick V, Byrd-Bredbenner C. Accuracy and consistency of weights provided by home bathroom scales. BMC Public Health. 2013 Dec 17;13:1194. doi: 10.1186/1471-2458-13-1194.
PubMed 24341761Perret C, Poiraudeau S, Fermanian J, Colau MM, Benhamou MA, Revel M. Validity, reliability, and responsiveness of the fingertip-to-floor test. Arch Phys Med Rehabil. 2001 Nov;82(11):1566-70. doi: 10.1053/apmr.2001.26064.
PubMed 11689977Helou K, El Helou N, Mahfouz M, Mahfouz Y, Salameh P, Harmouche-Karaki M. Validity and reliability of an adapted arabic version of the long international physical activity questionnaire. BMC Public Health. 2017 Jul 24;18(1):49. doi: 10.1186/s12889-017-4599-7.
PubMed 28738790Kim Y, Park I, Kang M. Convergent validity of the international physical activity questionnaire (IPAQ): meta-analysis. Public Health Nutr. 2013 Mar;16(3):440-52. doi: 10.1017/S1368980012002996. Epub 2012 Jul 2.
PubMed 22874087Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
PubMed 25262247Amundsen PA, Evans DW, Rajendran D, Bright P, Bjorkli T, Eldridge S, Buchbinder R, Underwood M, Froud R. Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord. 2018 Apr 12;19(1):113. doi: 10.1186/s12891-018-2034-6.
PubMed 29650015Naguib PR, Elsayaad MM, Mohamed HH, Lasheen YR. Efficacy of side lying traction versus supine lying traction in treatment of lumbar disc herniation: A randomized controlled trial
Kumari A, Quddus N, Meena PR, Alghadir AH, Khan M. Effects of One-Fifth, One-Third, and One-Half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients: A Randomized Controlled Trial. Biomed Res Int. 2021 Sep 16;2021:2561502. doi: 10.1155/2021/2561502. eCollection 2021.
PubMed 34568490Kılıç Ç, Öz B, Ölmez N, Günay Uçurum S, Memiş A. Clinical and Functional Effects of Traction for Lumbar Disk Hernia Patients. Acta Med Nicomedia. February 2021;4(1):4-10.
Khan RR, Riaz S, Rashid S, Sulman M. Effectiveness of mechanical traction in supine versus prone lying position for lumbosacral radiculopathy. Pak J Med Sci. 2021 Sep-Oct;37(5):1451-1455. doi: 10.12669/pjms.37.5.4200.
PubMed 34475929Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
PubMed 26813755Vanti C, Panizzolo A, Turone L, Guccione AA, Violante FS, Pillastrini P, Bertozzi L. Effectiveness of Mechanical Traction for Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Phys Ther. 2021 Mar 3;101(3):pzaa231. doi: 10.1093/ptj/pzaa231.
PubMed 33382419
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Positions During Traction on Pain, Function, and Range of Motion in Adults with Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06812338
- Acronym / sponsor ID
- RHPT/024/020
- Conditions
- Non-specific Low Back Pain, Lumbar Traction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Feb 2025 (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.
Our primary purpose for this study is to investigate the effect of different positions during traction on pain, function, and range of motion in adults with non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- It will be a triple-armed Randomized control trial, 30 subject will be recruited and randomly allocated into the three groups (supine, prone, and side-lying) using sealed envelope method, same treatment will be delivered with difference in positioning only, Supine Participants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90°, Prone Participants will lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis. Side-lying Participants will lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between his knees.
| Arm | Type | Receives |
|---|---|---|
| Supine Participants | Active comparator | Device: mechanical tractionParticipants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90° |
| Prone Participants | Active comparator | Device: mechanical tractionwill lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis |
| Side-lying Participants | Active comparator | Device: mechanical tractionwill lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between their knees |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18-65 years of age
- Non specific LBP persisted for more than 12 weeks
- At least 4/10 on NPRS
Key exclusion criteria (10 listed)
- Vertebral fractures
- Axial spondylarthritis
- Aauda equina syndrome
- Radicular pain
- Radiculopathy
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 tractionParticipants will receive traction therapy as follows: force will start at 25% of Body weight, gradually increasing until the tolerance for pulling is reached with maximum of 50% of body weight. The session will be 15 minutes long (1min for acceleration, 13 min application, 1min deceleration); it will be intermittent with ratio of 30 s on and 10s off | Device | Prone Participants, Side-lying Participants, Supine Participants |
Primary outcome
Oswestry Disability Index (ODI) Arabic version
Time frame: from baseline to the end of the 6th week
assesses the impact of back pain on daily life across 10 sections. Each section covers different activities and aspects of daily living. The responses are scored from 0 (no impact) to 5 (maximum impact), with higher scores indicating greater disability
3 secondary outcomes
International Physical Activity Questionnaire (IPAQ) arabic version
Time frame: from baseline to the end of the 6th week
Numerical pain rating scale (NPRS)
Time frame: from baseline to the end of the 6th week
Finger-to-floor test (FFT)
Time frame: from baseline to the end of the 6th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 18226650Beattie PF, Nelson RM, Michener LA, Cammarata J, Donley J. Outcomes after a prone lumbar traction protocol for patients with activity-limiting low back pain: a prospective case series study. Arch Phys Med Rehabil. 2008 Feb;89(2):269-74. doi: 10.1016/j.apmr.2007.06.778.
- Background: PubMed 33269579Tanovic E, Celik D, Omerovic D, Zovko Omeragic V, Jaganjac A, Konjo H, Rovcanin E, Omerovic H. Intermittent traction therapy in the treatment of chronic low back pain. Med Glas (Zenica). 2021 Feb 1;18(1):158-163. doi: 10.17392/1252-21.
- Background: PubMed 24341761Yorkin M, Spaccarotella K, Martin-Biggers J, Quick V, Byrd-Bredbenner C. Accuracy and consistency of weights provided by home bathroom scales. BMC Public Health. 2013 Dec 17;13:1194. doi: 10.1186/1471-2458-13-1194.
- Background: PubMed 11689977Perret C, Poiraudeau S, Fermanian J, Colau MM, Benhamou MA, Revel M. Validity, reliability, and responsiveness of the fingertip-to-floor test. Arch Phys Med Rehabil. 2001 Nov;82(11):1566-70. doi: 10.1053/apmr.2001.26064.
- Background: PubMed 28738790Helou K, El Helou N, Mahfouz M, Mahfouz Y, Salameh P, Harmouche-Karaki M. Validity and reliability of an adapted arabic version of the long international physical activity questionnaire. BMC Public Health. 2017 Jul 24;18(1):49. doi: 10.1186/s12889-017-4599-7.
- Background: PubMed 22874087Kim Y, Park I, Kang M. Convergent validity of the international physical activity questionnaire (IPAQ): meta-analysis. Public Health Nutr. 2013 Mar;16(3):440-52. doi: 10.1017/S1368980012002996. Epub 2012 Jul 2.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Background: PubMed 25262247Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
- Background: PubMed 29650015Amundsen PA, Evans DW, Rajendran D, Bright P, Bjorkli T, Eldridge S, Buchbinder R, Underwood M, Froud R. Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord. 2018 Apr 12;19(1):113. doi: 10.1186/s12891-018-2034-6.
- BackgroundNaguib PR, Elsayaad MM, Mohamed HH, Lasheen YR. Efficacy of side lying traction versus supine lying traction in treatment of lumbar disc herniation: A randomized controlled trial
- Background: PubMed 34568490Kumari A, Quddus N, Meena PR, Alghadir AH, Khan M. Effects of One-Fifth, One-Third, and One-Half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients: A Randomized Controlled Trial. Biomed Res Int. 2021 Sep 16;2021:2561502. doi: 10.1155/2021/2561502. eCollection 2021.
- BackgroundKılıç Ç, Öz B, Ölmez N, Günay Uçurum S, Memiş A. Clinical and Functional Effects of Traction for Lumbar Disk Hernia Patients. Acta Med Nicomedia. February 2021;4(1):4-10.
- Individual participant dataSharing planned: Yes. Data will be provided upon request through the principal investigator's email.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical traction in people with Non-specific Low Back Pain and Lumbar Traction, run by Prince Sattam Bin Abdulaziz University.
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 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: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waleed S.E. Mahmoud, Doctoral in Physical therapy (+966-56-311-4324, w.mahmoud@psau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) Arabic version (time frame: from baseline to the end of the 6th week). 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 NCT06812338, which also lists 37 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 6 Feb 2025.