HypomotilityNCT04521244
Lumbar Manipulation in Lumbar Hypomobility
A study testing Thrust joint lumbar manipulation and Lumbar mobilization in people with Hypomotility and Lumbar Spine Instability, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the immediate effects of thrust versus non-thrust lumbar manipulation in individuals with lumbar hypo-mobility on lumbar range of motion and springing force tolerance. A randomized control trial was conducted at Max Rehab and Physical Therapy Centre, Islamabad. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomotility, Lumbar Spine Instability
- What is being tested?
- Thrust joint lumbar manipulation and Lumbar mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2019to 9 Nov 2020
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both Genders
- Participants having Lumbar flexion ≤ 30ᴼ
- Participants having lumbar extension ≤15ᴼ
- Participants having lumbar side bending ≤ 15ᴼ.
- Grade 1 \& 2 hypo-mobility (Stanley Paris Grading System)
- Springing force tolerance measured through Pressure Algometry using Digital
- Algometer whose value can be taken in kg or lb.
- Checklist of Red Flags of TJM Lumbar Spine (Tumor, any bacterial or viral infection like Tuberculosis, UTI which is accompanying any neurological impairments i.e loss of sensations in extremities, Severe Rheumatoid Arthritis,Osteomalacia or Osteoporosis, cervical myelopathy, cord compression,cauda equina syndrome, Bowel and bladder changes, motor vehicle accident or fall, Muscle weakness or atrophy, any history of immunosuppression e.g. steroids, HIV, Abnormal Deep tendon reflexes, Headache, confusion, Abnormal and constant changes in pain pattern, Bilateral or Unilateral Sciatica.)
Who cannot join
- Participants having normomobility and hypermobility (according to Beighton Score, a score of 4 or more out of 9 indicates generalized hypermobility of the Joints).
- Participants having fracture and lumbar prolapsed intervertebral disc
- Participants having Spondylolisthesis, Lumbar Trauma, any musculoskeletal or cardiorespiratory disorders that affects lumbar spine mobility like (SI, Hip Joint, Thoracic Spine dysfunction)
- Participants who received any therapy for lumbar region past 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Thrust Versus Non-thrust Lumbar Manipulation on Mobility and Springing Force Tolerance in Lumbar Hypomobility
The purpose of the study is to compare the immediate effects of thrust versus non-thrust lumbar manipulation in individuals with lumbar hypo-mobility on lumbar range of motion and springing force tolerance. A randomized control trial was conducted at Max Rehab and Physical Therapy Centre, Islamabad. The sample size was 18 calculated through open-epi tool but I recruited 60. The participants were divided into two interventional groups each having 30 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 20 to 35 years participants with grade one or two hypo-mobility at lumbar region were included in the study. Tools used in this study are Goniometer, Inclinometers (lumbar Inclinometry using dual inclinometer method),Digital Algometer, Self structured Questionnaire. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 23.
Read the detailed description
A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were lumbar manipulation, hypo-mobility, spinal stiffness, non-thrust manipulation, lumbar mobilizations, segmentalstiffness.The purpose of the literature review is to find out the pre-existing literature regarding the Lumbar mobilizations and TJM interventions for Lumbar Hypomobility.
In 2019 a systematic review conducted by Aoyagi et al on effectiveness of spinal mobilization stated that there is a moderate to high quality evidence on Spinal mobilizations as effective intervention in low back pain as it decreases pain and improve Range of motion In 2019,a systematic review conducted by Hofstetter et al on Instrumented measurement of spinal stiffness stated that mechanical devices revealed excellent reliability tool to measure Spinal stiffness especially in prone position.
In 2019, a systematic review and meta-analysis conducted by a chi Ngai Lo et al on Spinal manipulation stated that HVLAT is highly effective as an treatment protocol then no intervention or sham manipulation because it improves muscle strength in healthy population
- Conditions
- Hypomotility, Lumbar Spine Instability
- Being tested
- Thrust joint lumbar manipulation, Lumbar mobilization
- Keywords
- Lumbar Mobilization, Hypo-mobility, Spinal or segmental stiffness, Lumbar Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust joint lumbar manipulationOther
Moist Hot pack of 14/15' over lumbar region for 15 mins. Hydro collator Temperature according to standardized hot pack is 40-45οC.Bilateral Thrust Manipulation of Lumbar Spine from L1-L5 Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometer for lumbar flexion, extension and goniometer for lumbar side bending.These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.
Lumbar mobilizationOther
Moist Hot pack of 14/15' from L1 where ribcage ends up to the region of gluteal folds for 15 mins. Non Thrust Manipulation for 30 seconds Using Kaltenborn grade 3 (Stretch rotation mobilization).Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometerfor lumbar flexion, extension and goniometer for lumbar side bending. These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.
| Study group | Role | What they receive |
|---|---|---|
| Thrust joint lumbar manipulation | Experimental | Thrust joint lumbar manipulation (Lumbar rotation manipulation) ,Moist Hot pack Receives: Other: Thrust joint lumbar manipulation |
| Lumbar mobilization | Active comparator | Lumbar mobilization (Stretch rotation mobilization), Moist Hot pack Receives: Other: Lumbar mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire)
It is 0-6 PIVM Grading system for manual grading of Rotatoric Movement.From 0-2 grades considered as Hypo-mobility. Grade 1 is considerable decreased movement and grade 2 is slight decreased movement at the lumbar region.As per my inclusion criteria, participants with grade 1 \& 2 hypo-mobility were included.On the basis of screening questionnaire, lumbar hypo-mobility was diagnosed by Stanley Paris grading system and after taking demographics in self-structured questionnaire, pre and post intervention values were mentioned in the Questionnaire.0 grade is no movement (ankylosis or fused) while 6 grade is complete instability.
Measured: On Day 1
ROM Lumbar spine ( Flexion)
Participants having lumbar flexion ≤ 30° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar flexion was taken with the Help of Inclinometers. Standard normative value for lumbar range for flexion is 40-60°.
Measured: On Day 1
ROM Lumbar spine (Extension)
Participants having lumbar extension ≤ 15° were recruited. Changes from the Baseline ROM (range of Motion) of Lumbar extension was taken with the Help of Inclinometers. Standard normative value for lumbar range of extension is 20-35°.
Measured: On Day 1
ROM Lumbar spine (Side Bending)
Participants having side bending ≤ 15° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar side bending was taken with the Help of Goniometer. Standard normative value for lumbar range of side bending is 15-20°.
Measured: On Day 1
Secondary outcomes (1)
Pressure Pain Threshold (PPT)
Changes from Baseline Pressure Pain Threshold (PPT) were taken with the help of digital algometer.which measures springing force tolerance in kg or lb.
Measured: On Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start5 Nov 2019
- Primary completion30 Sep 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypomotilityStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521244
- Sponsor's protocol ID
- REC/00695 Saba Nawaz
- Status last verified
- Nov 2020
- First submitted
- 18 Aug 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
PubMed 29371112Hurwitz EL, Randhawa K, Torres P, Yu H, Verville L, Hartvigsen J, Cote P, Haldeman S. The Global Spine Care Initiative: a systematic review of individual and community-based burden of spinal disorders in rural populations in low- and middle-income communities. Eur Spine J. 2018 Sep;27(Suppl 6):802-815. doi: 10.1007/s00586-017-5393-z. Epub 2017 Dec 27.
PubMed 29282539Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
PubMed 24665116Olotu JE, Okon M. Prevalence of Low Back Pain in a Southern Nigerian Population.
Yang K. Outpatient rehabilitation for a patient with chronic low back stiffness. 2019.
Petersson M, Abbott A. Lumbar interspinous pressure pain threshold values for healthy young men and women and the effect of prolonged fully flexed lumbar sitting posture: An observational study. World J Orthop. 2020 Mar 18;11(3):158-166. doi: 10.5312/wjo.v11.i3.158. eCollection 2020 Mar 18.
PubMed 32280605Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
PubMed 30658622Aoyagi K, Heller D, Hazlewood D, Sharma N, Dos Santos M. Is spinal mobilization effective for low back pain?: A systematic review. Complement Ther Clin Pract. 2019 Feb;34:51-63. doi: 10.1016/j.ctcp.2018.11.003. Epub 2018 Nov 5. No abstract available.
PubMed 30712746Hofstetter L, Hausler M, Wirth B, Swanenburg J. Instrumented Measurement of Spinal Stiffness: A Systematic Literature Review of Reliability. J Manipulative Physiol Ther. 2018 Oct;41(8):704-711. doi: 10.1016/j.jmpt.2018.03.002. Epub 2019 Jan 3.
PubMed 30612717Lo CN, Ng J, Au CK, Lim ECW. The Effectiveness of Spinal Manipulation in Increasing Muscle Strength in Healthy Individuals: A Systematic Review and Meta-Analysis. J Manipulative Physiol Ther. 2019 Feb;42(2):148-158. doi: 10.1016/j.jmpt.2018.10.003.
PubMed 31126523
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Thrust Versus Non-thrust Lumbar Manipulation on Mobility and Springing Force Tolerance in Lumbar Hypomobility
- ClinicalTrials.gov ID
- NCT04521244
- Acronym / sponsor ID
- REC/00695 Saba Nawaz
- Conditions
- Hypomotility, Lumbar Spine Instability
- Keywords
- Lumbar Mobilization, Hypo-mobility, Spinal or segmental stiffness, Lumbar Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 20 Aug 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.
The purpose of the study is to compare the immediate effects of thrust versus non-thrust lumbar manipulation in individuals with lumbar hypo-mobility on lumbar range of motion and springing force tolerance. A randomized control trial was conducted at Max Rehab and Physical Therapy Centre, Islamabad. The sample size was 18 calculated through open-epi tool but I recruited 60. The participants were divided into two interventional groups each having 30 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 20 to 35 years participants with grade one or two hypo-mobility at lumbar region were included in the study. Tools used in this study are Goniometer, Inclinometers (lumbar Inclinometry using dual inclinometer method),Digital Algometer, Self structured Questionnaire. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 23.
Detailed description
A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were lumbar manipulation, hypo-mobility, spinal stiffness, non-thrust manipulation, lumbar mobilizations, segmentalstiffness.The purpose of the literature review is to find out the pre-existing literature regarding the Lumbar mobilizations and TJM interventions for Lumbar Hypomobility.
In 2019 a systematic review conducted by Aoyagi et al on effectiveness of spinal mobilization stated that there is a moderate to high quality evidence on Spinal mobilizations as effective intervention in low back pain as it decreases pain and improve Range of motion In 2019,a systematic review conducted by Hofstetter et al on Instrumented measurement of spinal stiffness stated that mechanical devices revealed excellent reliability tool to measure Spinal stiffness especially in prone position.
In 2019, a systematic review and meta-analysis conducted by a chi Ngai Lo et al on Spinal manipulation stated that HVLAT is highly effective as an treatment protocol then no intervention or sham manipulation because it improves muscle strength in healthy population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust joint lumbar manipulation | Experimental | Other: Thrust joint lumbar manipulationThrust joint lumbar manipulation (Lumbar rotation manipulation) ,Moist Hot pack |
| Lumbar mobilization | Active comparator | Other: Lumbar mobilizationLumbar mobilization (Stretch rotation mobilization), Moist Hot pack |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Both Genders
- Participants having Lumbar flexion ≤ 30ᴼ
- Participants having lumbar extension ≤15ᴼ
- Participants having lumbar side bending ≤ 15ᴼ.
- Grade 1 \& 2 hypo-mobility (Stanley Paris Grading System)
Key exclusion criteria (4 listed)
- Participants having normomobility and hypermobility (according to Beighton Score, a score of 4 or more out of 9 indicates generalized hypermobility of the Joints).
- Participants having fracture and lumbar prolapsed intervertebral disc
- Participants having Spondylolisthesis, Lumbar Trauma, any musculoskeletal or cardiorespiratory disorders that affects lumbar spine mobility like (SI, Hip Joint, Thoracic Spine dysfunction)
- Participants who received any therapy for lumbar region past 3 days
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 |
|---|---|---|
| Thrust joint lumbar manipulationMoist Hot pack of 14/15' over lumbar region for 15 mins. Hydro collator Temperature according to standardized hot pack is 40-45οC.Bilateral Thrust Manipulation of Lumbar Spine from L1-L5 Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometer for lumbar flexion, extension and goniometer for lumbar side bending.These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay. | Other | Thrust joint lumbar manipulation |
| Lumbar mobilizationMoist Hot pack of 14/15' from L1 where ribcage ends up to the region of gluteal folds for 15 mins. Non Thrust Manipulation for 30 seconds Using Kaltenborn grade 3 (Stretch rotation mobilization).Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometerfor lumbar flexion, extension and goniometer for lumbar side bending. These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay. | Other | Lumbar mobilization |
Primary outcome
Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire)
Time frame: On Day 1
It is 0-6 PIVM Grading system for manual grading of Rotatoric Movement.From 0-2 grades considered as Hypo-mobility. Grade 1 is considerable decreased movement and grade 2 is slight decreased movement at the lumbar region.As per my inclusion criteria, participants with grade 1 \& 2 hypo-mobility were included.On the basis of screening questionnaire, lumbar hypo-mobility was diagnosed by Stanley Paris grading system and after taking demographics in self-structured questionnaire, pre and post intervention values were mentioned in the Questionnaire.0 grade is no movement (ankylosis or fused) while 6 grade is complete instability.
ROM Lumbar spine ( Flexion)
Time frame: On Day 1
Participants having lumbar flexion ≤ 30° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar flexion was taken with the Help of Inclinometers. Standard normative value for lumbar range for flexion is 40-60°.
ROM Lumbar spine (Extension)
Time frame: On Day 1
Participants having lumbar extension ≤ 15° were recruited. Changes from the Baseline ROM (range of Motion) of Lumbar extension was taken with the Help of Inclinometers. Standard normative value for lumbar range of extension is 20-35°.
ROM Lumbar spine (Side Bending)
Time frame: On Day 1
Participants having side bending ≤ 15° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar side bending was taken with the Help of Goniometer. Standard normative value for lumbar range of side bending is 15-20°.
1 secondary outcome
Pressure Pain Threshold (PPT)
Time frame: On Day 1
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 13 Nov 2020.
- Background: PubMed 29371112Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
- Background: PubMed 29282539Hurwitz EL, Randhawa K, Torres P, Yu H, Verville L, Hartvigsen J, Cote P, Haldeman S. The Global Spine Care Initiative: a systematic review of individual and community-based burden of spinal disorders in rural populations in low- and middle-income communities. Eur Spine J. 2018 Sep;27(Suppl 6):802-815. doi: 10.1007/s00586-017-5393-z. Epub 2017 Dec 27.
- Background: PubMed 24665116Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
- BackgroundOlotu JE, Okon M. Prevalence of Low Back Pain in a Southern Nigerian Population.
- BackgroundYang K. Outpatient rehabilitation for a patient with chronic low back stiffness. 2019.
- Background: PubMed 32280605Petersson M, Abbott A. Lumbar interspinous pressure pain threshold values for healthy young men and women and the effect of prolonged fully flexed lumbar sitting posture: An observational study. World J Orthop. 2020 Mar 18;11(3):158-166. doi: 10.5312/wjo.v11.i3.158. eCollection 2020 Mar 18.
- Background: PubMed 30658622Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
- Background: PubMed 30712746Aoyagi K, Heller D, Hazlewood D, Sharma N, Dos Santos M. Is spinal mobilization effective for low back pain?: A systematic review. Complement Ther Clin Pract. 2019 Feb;34:51-63. doi: 10.1016/j.ctcp.2018.11.003. Epub 2018 Nov 5. No abstract available.
- Background: PubMed 30612717Hofstetter L, Hausler M, Wirth B, Swanenburg J. Instrumented Measurement of Spinal Stiffness: A Systematic Literature Review of Reliability. J Manipulative Physiol Ther. 2018 Oct;41(8):704-711. doi: 10.1016/j.jmpt.2018.03.002. Epub 2019 Jan 3.
- Background: PubMed 31126523Lo CN, Ng J, Au CK, Lim ECW. The Effectiveness of Spinal Manipulation in Increasing Muscle Strength in Healthy Individuals: A Systematic Review and Meta-Analysis. J Manipulative Physiol Ther. 2019 Feb;42(2):148-158. doi: 10.1016/j.jmpt.2018.10.003.
- Individual participant dataSharing planned: No
Related trials for Hypomotility
RecruitingPhase 3
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Slow Transit Constipation, Pharmacotherapy
Active, not recruiting
STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Slow Transit Constipation, Surgery
Not yet recruitingObservational study
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Constipation, Slow Transit Constipation
Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Chronic Constipation, Slow Transit Constipation
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.
Lal Gul Khan, MScPT 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 Thrust joint lumbar manipulation and Lumbar mobilization in people with Hypomotility and Lumbar Spine Instability, 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 8 inclusion and 4 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 13 Nov 2020. 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?
Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire) (time frame: On Day 1). The study lists 4 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 NCT04521244, which also lists 10 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 13 Nov 2020.