Mechanical Low Back PainNCT05052840
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain
A study testing Muscle endurance training (MET) and Conventional Treatment in people with Mechanical Low Back Pain and Paraspinal Muscles, run by Riphah International University at 1 site in Pakistan.
Trial summary
Low back pain is one the leading cause of disability and affecting many individuals. Chronic low back pain is associated with restriction in daily physical activities that ultimately leads to disuse atrophy of muscles. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Mechanical Low Back Pain, Paraspinal Muscles, Muscle Stretching Exercises
- What is being tested?
- Muscle endurance training (MET) and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Sep 2021to 25 Feb 2022
- 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
- The ages between 20-45 years
- Both Males and Females
- The presence of low back pain as a primary complaint
- The onset of pain at least three months back
Who cannot join
- Tumors, infection or inflammatory diseases affecting the spine
- Spinal or lower limb surgery
- Spinal fractures or structural deformities such as spinal stenosis, spondylolisthesis and spondylolysis
- Signs of nerve root compression
- Any contraindications for exercise therapy
- Patient with any spinal surgery, have respiratory or systemic diseases.
- Pregnant women.
- Sacroiliac joint dysfunction (determined by any three positives among distraction test, Gaenslen's test, Thigh thrust test, Sacral thrust test, and compression test)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Back Muscles Endurance Training on Pain, Disability, Endurance and Lumbar Flexibility in Patients With Chronic Mechanical Low Back Pain
Low back pain is one the leading cause of disability and affecting many individuals. Chronic low back pain is associated with restriction in daily physical activities that ultimately leads to disuse atrophy of muscles. The objective of the study is to find out the effects of Back Muscles Endurance Training on pain, disability, endurance and Lumbar flexibility in patients with chronic mechanical low back pain.
Read the detailed description
Low back pain is the leading worldwide cause of years lost to disability and its burden is growing alongside the increasing and ageing population. Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Most patients who experience activity-limiting low back pain go on to have recurrent episodes. Low back pain is a common condition affecting many individuals at some point in their lives. Chronic low back pain prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.
- Being tested
- Muscle endurance training (MET), Conventional Treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle endurance training (MET)Other
Experimental group will be given MET Program, stretching \& strengthening exercises and Hot packs (for 15 minutes). MET program will include warm up, endurance and cool down exercises. The warm up and cool down period will be consisted of 5-minute walking, and 10 repetitions of stretching exercises. Endurance exercises will consist of 4 levels.
Conventional TreatmentOther
Conventional treatment group will be given hot packs (for 15 minutes) and Strengthening \& stretching exercise program including:
STRETCHING EXERCISES (lumbar extensor muscles, iliopsoas muscles, hamstring muscles, gastrocnemius muscles and pectoral muscles).
STRENGTHENING EXERCISES (rectus abdominus crunch, oblique crunch, pelvic elevation, single leg pelvic elevation, lumbal spine extension, on hands and knees position with the raise of one leg, on hands and knees position with the raise of opposite arm and leg). Each exercise will be repeated 10 times.
| Study group | Role | What they receive |
|---|---|---|
| Muscle endurance training (MET) | Experimental | Not described Receives: Other: Muscle endurance training (MET); Other: Conventional Treatment |
| Conventional Treatment | Active comparator | Not described Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERIC PAIN RATING SCALE
NPRS is anchored by terms describing pain severity extremes. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Measured: 6 weeks
REVISED OSWESTERY DISABILITY INDEX (RODQ)
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. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used.
Measured: 6 weeks
PRONE DOUBLE STRAIGHT-LEG RAISE TEST
The prone double straight-leg raise test will be used to assess participants' back muscle endurance. The participant lay on the plinth in prone-lying position, hips extended, with the hands underneath the forehead and the arms perpendicular to the body. Instruct the participant to raise both legs until knee clearance is achieved. The researcher will monitoring knee clearance by sliding one hand under the thighs. The time taken by participant to maintain knee clearance monitored with a stopwatch will be recorded in seconds as back muscle endurance
Measured: 6 weeks
MODIFIED SCHOBER'S TEST
The patient is standing with his back towards the examiner. The examiner determines the location of the lumbosacral junction at the level of the posterior superior iliac spine by pressing the location of the dimples of Venus. The intersection of the top of the dimples of Venus is marked by drawing a horizontal line. This line acts as the landmark. Two other marks will be drawn 10 cm above and 5 cm below the first landmark. The patient will then be asked to bend over and touch his or her toes as long as possible without increasing pain. The examiner will measure the increase in distance between the superior and inferior marks. The length increment, which is the difference between the 15-cm distance (neutral position) and the increased distance (anterior flexion posture), will be calculated to determine the range of motion of the lumbar spine
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start13 Sep 2021
- Primary completion13 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saima Zahid, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052840
- Sponsor's protocol ID
- REC/Lhr/0125 Faraz
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.
PubMed 29573871Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
PubMed 30252425Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
PubMed 26487293Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
PubMed 29067082Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Rigoard P, Blond S, David R, Mertens P. Pathophysiological characterisation of back pain generators in failed back surgery syndrome (part B). Neurochirurgie. 2015 Mar;61 Suppl 1:S35-44. doi: 10.1016/j.neuchi.2014.10.104. Epub 2014 Nov 20.
PubMed 25456443Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
PubMed 27408698Emami F, Yoosefinejad AK, Razeghi M. Correlations between core muscle geometry, pain intensity, functional disability and postural balance in patients with nonspecific mechanical low back pain. Med Eng Phys. 2018 Oct;60:39-46. doi: 10.1016/j.medengphy.2018.07.006. Epub 2018 Aug 1.
PubMed 30077486Shiri R, Coggon D, Falah-Hassani K. Exercise for the Prevention of Low Back Pain: Systematic Review and Meta-Analysis of Controlled Trials. Am J Epidemiol. 2018 May 1;187(5):1093-1101. doi: 10.1093/aje/kwx337.
PubMed 29053873
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Back Muscles Endurance Training on Pain, Disability, Endurance and Lumbar Flexibility in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05052840
- Acronym / sponsor ID
- REC/Lhr/0125 Faraz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 22 Sep 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.
Low back pain is one the leading cause of disability and affecting many individuals. Chronic low back pain is associated with restriction in daily physical activities that ultimately leads to disuse atrophy of muscles. The objective of the study is to find out the effects of Back Muscles Endurance Training on pain, disability, endurance and Lumbar flexibility in patients with chronic mechanical low back pain.
Detailed description
Low back pain is the leading worldwide cause of years lost to disability and its burden is growing alongside the increasing and ageing population. Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Most patients who experience activity-limiting low back pain go on to have recurrent episodes. Low back pain is a common condition affecting many individuals at some point in their lives. Chronic low back pain prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle endurance training (MET) | Experimental | Other: Muscle endurance training (MET), Other: Conventional Treatment |
| Conventional Treatment | Active comparator | Other: Conventional Treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The ages between 20-45 years
- Both Males and Females
- The presence of low back pain as a primary complaint
- The onset of pain at least three months back
Key exclusion criteria (8 listed)
- Tumors, infection or inflammatory diseases affecting the spine
- Spinal or lower limb surgery
- Spinal fractures or structural deformities such as spinal stenosis, spondylolisthesis and spondylolysis
- Signs of nerve root compression
- Any contraindications for exercise therapy
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 |
|---|---|---|
| Muscle endurance training (MET)Experimental group will be given MET Program, stretching \& strengthening exercises and Hot packs (for 15 minutes). MET program will include warm up, endurance and cool down exercises. The warm up and cool down period will be consisted of 5-minute walking, and 10 repetitions of stretching exercises. Endurance exercises will consist of 4 levels. | Other | Muscle endurance training (MET) |
| Conventional TreatmentConventional treatment group will be given hot packs (for 15 minutes) and Strengthening \& stretching exercise program including: STRETCHING EXERCISES (lumbar extensor muscles, iliopsoas muscles, hamstring muscles, gastrocnemius muscles and pectoral muscles). STRENGTHENING EXERCISES (rectus abdominus crunch, oblique crunch, pelvic elevation, single leg pelvic elevation, lumbal spine extension, on hands and knees position with the raise of one leg, on hands and knees position with the raise of opposite arm and leg). Each exercise will be repeated 10 times. | Other | Conventional Treatment, Muscle endurance training (MET) |
Primary outcome
NUMERIC PAIN RATING SCALE
Time frame: 6 weeks
NPRS is anchored by terms describing pain severity extremes. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
REVISED OSWESTERY DISABILITY INDEX (RODQ)
Time frame: 6 weeks
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. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used.
PRONE DOUBLE STRAIGHT-LEG RAISE TEST
Time frame: 6 weeks
The prone double straight-leg raise test will be used to assess participants' back muscle endurance. The participant lay on the plinth in prone-lying position, hips extended, with the hands underneath the forehead and the arms perpendicular to the body. Instruct the participant to raise both legs until knee clearance is achieved. The researcher will monitoring knee clearance by sliding one hand under the thighs. The time taken by participant to maintain knee clearance monitored with a stopwatch will be recorded in seconds as back muscle endurance
MODIFIED SCHOBER'S TEST
Time frame: 6 weeks
The patient is standing with his back towards the examiner. The examiner determines the location of the lumbosacral junction at the level of the posterior superior iliac spine by pressing the location of the dimples of Venus. The intersection of the top of the dimples of Venus is marked by drawing a horizontal line. This line acts as the landmark. Two other marks will be drawn 10 cm above and 5 cm below the first landmark. The patient will then be asked to bend over and touch his or her toes as long as possible without increasing pain. The examiner will measure the increase in distance between the superior and inferior marks. The length increment, which is the difference between the 15-cm distance (neutral position) and the increased distance (anterior flexion posture), will be calculated to determine the range of motion of the lumbar spine
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 Apr 2022.
- Background: PubMed 29573871Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.
- Background: PubMed 30252425Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- Background: PubMed 26487293Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
- Background: PubMed 29067082Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
- Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- Background: PubMed 25456443Rigoard P, Blond S, David R, Mertens P. Pathophysiological characterisation of back pain generators in failed back surgery syndrome (part B). Neurochirurgie. 2015 Mar;61 Suppl 1:S35-44. doi: 10.1016/j.neuchi.2014.10.104. Epub 2014 Nov 20.
- Background: PubMed 27408698Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
- Background: PubMed 30077486Emami F, Yoosefinejad AK, Razeghi M. Correlations between core muscle geometry, pain intensity, functional disability and postural balance in patients with nonspecific mechanical low back pain. Med Eng Phys. 2018 Oct;60:39-46. doi: 10.1016/j.medengphy.2018.07.006. Epub 2018 Aug 1.
- Background: PubMed 29053873Shiri R, Coggon D, Falah-Hassani K. Exercise for the Prevention of Low Back Pain: Systematic Review and Meta-Analysis of Controlled Trials. Am J Epidemiol. 2018 May 1;187(5):1093-1101. doi: 10.1093/aje/kwx337.
- 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.
Saima Zahid, PhD* 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 Muscle endurance training (MET) and Conventional Treatment in people with Mechanical Low Back Pain and Paraspinal Muscles, 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 4 inclusion and 8 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 Apr 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?
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: 6 weeks). 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 NCT05052840, which also lists 9 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 Apr 2022.