Chronic Nonspecific Low Back PainNCT04801212
The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain.
A study testing core stability exercises with teeth clenching and core stability exercises in people with Chronic Nonspecific Low Back Pain and Core Stability, run by University of Lahore at 1 site in Pakistan.
Trial summary
Core stability strength \& coordination is necessary to perform smooth \& coordinated upper \& lower extremity movements \& function. Altered core stability muscle strength, coordination \& poor motor control can cause low back pain (LBP). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain, Core Stability, Jaw Movements
- What is being tested?
- core stability exercises with teeth clenching and core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 30 Apr 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- · Participants having chronic low back pain lasting more than 12 weeks.
- Age 20-45 years
- Participants having nonspecific chronic low back pain with or without referred leg pain.
- Both male and female patients.
- Currently seeking care for low back pain.
- No known TMJ pathology.
- Had Magnetic Resonance Image (MRI) to exclude serious pathology and been diagnosed by the consultant and non-specific low back pain.
Who cannot join
- · Participants with known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome/widespread neurological disorder, lumbar spondylosis, stenosis, spondylolisthesis).
- Compromised nerve root
- Previous spinal surgery or scheduled for major surgery during the treatment.
- Co-morbid health conditions that would prevent active participation in the exercise programs such as asthma.
- Low back pain having less than 12 weeks history.
- Known Temporomandibular joint pathology or jaw pain.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Physical Medicine & Rehabilitation
Karachi, Sindh, 75400
About this study
Core stability strength \& coordination is necessary to perform smooth \& coordinated upper \& lower extremity movements \& function. Altered core stability muscle strength, coordination \& poor motor control can cause low back pain (LBP). Physical therapists especially those working with children having neurodevelopmental problems or adults with neurological disorders such as stroke are aware of the concepts of global movements. In this concept, alterations in one body segment may bring changes in other body segments. In neurological rehabilitation, the concept of Neuro-Developmental Technique (NDT) introduced by Bobath got worldwide recognition. This concept states that there are specific key points in the neck, \& shoulders that can facilitate normal movements by enhancing the activity of core musculature in functional movements for instance, sit to stand \& walking. This concept was further explored by Burnstein and suggested that biomechanically body joints and motor control works together as functional unit and not as single limb movement. Bobath and proprioceptive neuromuscular facilitation (PNF) concepts further explained that movements of the eye, head and neck facilitate trunk movements. Electromyography studies have shown that both single and rhythmical jaw opening and closing movements not only produced well-coordinated jaw and head-neck movements but also produced atlanto-occipital and cervical spine joints movements. The author further concluded that mouth opening and closing in fetal yawning is associated with head extension-flexion movements indicating that functional connections between the jaw and head-neck is innate. A human jaw or masticatory system is connected to the motor system through cranial nerves unlike central motor system which is connected to the body through spinal motor system. Brainstem central pattern generator (CPG) control masticatory system through descending pathways and are involved in voluntary movements of the jaw such as mouth opening and closing. The higher brain centers cortical masticatory area and primary motor cortex control these movements. In the current back pain literature core stability exercises have been used in the management of chronic low back pain. The jaw is connected to the head-neck and neck is connected to the trunk. Therefore there is to study the effects of core stability exercises performed with and without jaw movements in the management of chronic low back pain.
Read the detailed description
A randomized experimental controlled trial will be carried out to compare the effectiveness of core stabilization exercises performed with and without jaw movements in the management of nonspecific chronic low back pain. A total of 80 male and female volunteers having subjects with chronic nonspecific low back pain will be recruited in this study. All subjects will be assessed for transverse abdominal muscle strength contraction, pain and disability using Pressure Biofeedback Unit (BPU), Numeric Pain Rating Scale (NPRS 0-10cm) and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. The scores on the mentioned scales will be documented as per guidelines. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform core stability exercises alone; Group 2 will perform core stability exercises with teeth clenching This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM\&R). The computer-generated random sampling technique will be used to allocate the participants into the study groups. Data will be analyzed using SPSS 22 and one-way repeated measure ANOVA will be applied to see the mean difference in the 2 groups. For pair-wise comparison, the Tukey test will be applied. For pain and disability scales Friedman's test will be applied to see the two scales' median differences.
- Being tested
- core stability exercises with teeth clenching, core stability exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability exercises with teeth clenchingOther
The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.
core stability exercisesOther
The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.
| Study group | Role | What they receive |
|---|---|---|
| core stability exercises with teeth clenching | Experimental | The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week. Receives: Other: core stability exercises with teeth clenching; Other: core stability exercises |
| core stability exercises alone | Active comparator | The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week. Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Measured: At baseline
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Measured: At 6th weeks
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Measured: At 12th weeks
Roland Morris Questionnaire (RMQ):
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Measured: At baseline
Roland Morris Questionnaire (RMQ):
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Measured: At 6th weeks
Roland Morris Questionnaire (RMQ):
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Measured: At 12th weeks
Pressure Biofeedback unit (PBU):
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Measured: At baseline
Pressure Biofeedback unit (PBU):
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Measured: A 6th weeks
Pressure Biofeedback unit (PBU):
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Measured: At 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Khan, University of Lahore
- Investigators
- Muhammad Khan, MSAPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801212
- Sponsor's protocol ID
- 00001
- Status last verified
- May 2023
- First submitted
- 3 Feb 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004.
PubMed 20434958Sung PS. Disability and back muscle fatigability changes following two therapeutic exercise interventions in participants with recurrent low back pain. Med Sci Monit. 2013 Jan 14;19:40-8. doi: 10.12659/msm.883735.
PubMed 23314589Raine S, Meadows L, Lynch-Ellerington M. Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. Wiley-Blackwell. 2009. 4- Bernstein, N. The Coordination and Regulation of Movement. Pergamon Press, Oxford. Bishop, B. 1967.
Adler SS, Beckers D, Buck M. PNF in Practice: An Illustrated Guide. New York, NY: Springer. 2007.
Voss DE, Ionta MK, Myers BJ. Proprioceptive Neuromuscular Facilitation. Patterns and Techniques. Philadelphia, PA: Harper & Row Publishers. 1985.
HUMPHREY T. The spinal tract of the trigeminal nerve in human embryos between 7 1/2 and 8 1/2 weeks of menstrual age and its relation to early fetal behavior. J Comp Neurol. 1952 May;97(1):143-209. doi: 10.1002/cne.900970109. No abstract available.
PubMed 12981197Zafar H, Eriksson PO, Nordh E, Haggman-Henrikson B. Wireless optoelectronic recordings of mandibular and associated head-neck movements in man: a methodological study. J Oral Rehabil. 2000 Mar;27(3):227-38. doi: 10.1046/j.1365-2842.2000.00505.x.
PubMed 10784335Zafar H, Nordh E, Eriksson PO. Temporal coordination between mandibular and head-neck movements during jaw opening-closing tasks in man. Arch Oral Biol. 2000 Aug;45(8):675-82. doi: 10.1016/s0003-9969(00)00032-7.
PubMed 10869479Barry J. Sessle ,LimorAvivi-Arber, and Gregory M. Murray. Motor Control of Masticatory Muscles. Craniofacial Muscles: A New Framework for Understanding the Effector Side of Craniofacial Muscle Control. L.K. McLoon and F.H. Andrade (eds.) Toronto. 2013.
Khan M, Zafar H, Gilani SA, Farooqui WA, Ahmad A. The effects of lumbar stabilization exercises with and without jaw movements in non-specific low back pain (A randomized controlled trial). Pak J Med Sci. 2024 Jul;40(6):1116-1121. doi: 10.12669/pjms.40.6.9208.
PubMed 38952498
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT04801212
- Acronym / sponsor ID
- 00001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Mar 2021 (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.
Core stability strength \& coordination is necessary to perform smooth \& coordinated upper \& lower extremity movements \& function. Altered core stability muscle strength, coordination \& poor motor control can cause low back pain (LBP). Physical therapists especially those working with children having neurodevelopmental problems or adults with neurological disorders such as stroke are aware of the concepts of global movements. In this concept, alterations in one body segment may bring changes in other body segments. In neurological rehabilitation, the concept of Neuro-Developmental Technique (NDT) introduced by Bobath got worldwide recognition. This concept states that there are specific key points in the neck, \& shoulders that can facilitate normal movements by enhancing the activity of core musculature in functional movements for instance, sit to stand \& walking. This concept was further explored by Burnstein and suggested that biomechanically body joints and motor control works together as functional unit and not as single limb movement. Bobath and proprioceptive neuromuscular facilitation (PNF) concepts further explained that movements of the eye, head and neck facilitate trunk movements. Electromyography studies have shown that both single and rhythmical jaw opening and closing movements not only produced well-coordinated jaw and head-neck movements but also produced atlanto-occipital and cervical spine joints movements. The author further concluded that mouth opening and closing in fetal yawning is associated with head extension-flexion movements indicating that functional connections between the jaw and head-neck is innate. A human jaw or masticatory system is connected to the motor system through cranial nerves unlike central motor system which is connected to the body through spinal motor system. Brainstem central pattern generator (CPG) control masticatory system through descending pathways and are involved in voluntary movements of the jaw such as mouth opening and closing. The higher brain centers cortical masticatory area and primary motor cortex control these movements. In the current back pain literature core stability exercises have been used in the management of chronic low back pain. The jaw is connected to the head-neck and neck is connected to the trunk. Therefore there is to study the effects of core stability exercises performed with and without jaw movements in the management of chronic low back pain.
Detailed description
A randomized experimental controlled trial will be carried out to compare the effectiveness of core stabilization exercises performed with and without jaw movements in the management of nonspecific chronic low back pain. A total of 80 male and female volunteers having subjects with chronic nonspecific low back pain will be recruited in this study. All subjects will be assessed for transverse abdominal muscle strength contraction, pain and disability using Pressure Biofeedback Unit (BPU), Numeric Pain Rating Scale (NPRS 0-10cm) and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. The scores on the mentioned scales will be documented as per guidelines. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform core stability exercises alone; Group 2 will perform core stability exercises with teeth clenching This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM\&R). The computer-generated random sampling technique will be used to allocate the participants into the study groups. Data will be analyzed using SPSS 22 and one-way repeated measure ANOVA will be applied to see the mean difference in the 2 groups. For pair-wise comparison, the Tukey test will be applied. For pain and disability scales Friedman's test will be applied to see the two scales' median differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stability exercises with teeth clenching | Experimental | Other: core stability exercises with teeth clenching, Other: core stability exercisesThe intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week. |
| core stability exercises alone | Active comparator | Other: core stability exercisesThe intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- · Participants having chronic low back pain lasting more than 12 weeks.
Key exclusion criteria (6 listed)
- · Participants with known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome/widespread neurological disorder, lumbar spondylosis, stenosis, spondylolisthesis).
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 |
|---|---|---|
| core stability exercises with teeth clenchingThe intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention. | Other | core stability exercises with teeth clenching |
| core stability exercisesThe intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention. | Other | core stability exercises alone, core stability exercises with teeth clenching |
Primary outcome
Numeric Pain Rating Scale
Time frame: At baseline
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Numeric Pain Rating Scale
Time frame: At 6th weeks
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Numeric Pain Rating Scale
Time frame: At 12th weeks
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Roland Morris Questionnaire (RMQ):
Time frame: At baseline
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Roland Morris Questionnaire (RMQ):
Time frame: At 6th weeks
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Roland Morris Questionnaire (RMQ):
Time frame: At 12th weeks
RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.
Pressure Biofeedback unit (PBU):
Time frame: At baseline
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Pressure Biofeedback unit (PBU):
Time frame: A 6th weeks
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Pressure Biofeedback unit (PBU):
Time frame: At 12th weeks
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
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 6 May 2023.
- Background: PubMed 20434958Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004.
- Background: PubMed 23314589Sung PS. Disability and back muscle fatigability changes following two therapeutic exercise interventions in participants with recurrent low back pain. Med Sci Monit. 2013 Jan 14;19:40-8. doi: 10.12659/msm.883735.
- BackgroundRaine S, Meadows L, Lynch-Ellerington M. Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. Wiley-Blackwell. 2009. 4- Bernstein, N. The Coordination and Regulation of Movement. Pergamon Press, Oxford. Bishop, B. 1967.
- BackgroundAdler SS, Beckers D, Buck M. PNF in Practice: An Illustrated Guide. New York, NY: Springer. 2007.
- BackgroundVoss DE, Ionta MK, Myers BJ. Proprioceptive Neuromuscular Facilitation. Patterns and Techniques. Philadelphia, PA: Harper & Row Publishers. 1985.
- Background: PubMed 12981197HUMPHREY T. The spinal tract of the trigeminal nerve in human embryos between 7 1/2 and 8 1/2 weeks of menstrual age and its relation to early fetal behavior. J Comp Neurol. 1952 May;97(1):143-209. doi: 10.1002/cne.900970109. No abstract available.
- Background: PubMed 10784335Zafar H, Eriksson PO, Nordh E, Haggman-Henrikson B. Wireless optoelectronic recordings of mandibular and associated head-neck movements in man: a methodological study. J Oral Rehabil. 2000 Mar;27(3):227-38. doi: 10.1046/j.1365-2842.2000.00505.x.
- Background: PubMed 10869479Zafar H, Nordh E, Eriksson PO. Temporal coordination between mandibular and head-neck movements during jaw opening-closing tasks in man. Arch Oral Biol. 2000 Aug;45(8):675-82. doi: 10.1016/s0003-9969(00)00032-7.
- BackgroundBarry J. Sessle ,LimorAvivi-Arber, and Gregory M. Murray. Motor Control of Masticatory Muscles. Craniofacial Muscles: A New Framework for Understanding the Effector Side of Craniofacial Muscle Control. L.K. McLoon and F.H. Andrade (eds.) Toronto. 2013.
- Derived from this study: PubMed 38952498Khan M, Zafar H, Gilani SA, Farooqui WA, Ahmad A. The effects of lumbar stabilization exercises with and without jaw movements in non-specific low back pain (A randomized controlled trial). Pak J Med Sci. 2024 Jul;40(6):1116-1121. doi: 10.12669/pjms.40.6.9208.
- 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.
Muhammad Khan, MSAPT principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stability exercises with teeth clenching and core stability exercises in people with Chronic Nonspecific Low Back Pain and Core Stability, run by University of Lahore 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 7 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 6 May 2023. 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?
Numeric Pain Rating Scale (time frame: At baseline). The study lists 9 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 NCT04801212, 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 6 May 2023.