- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052840
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain
Effects of Back Muscles Endurance Training on Pain, Disability, Endurance and Lumbar Flexibility in Patients With Chronic Mechanical Low Back Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Zohra Shafi Free Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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. |
|
Active Comparator: Conventional Treatment
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 weeks
|
|
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.
|
6 weeks
|
|
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
|
6 weeks
|
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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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Meucci 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.
- Akhtar 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.
- Allegri 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.
- Hartvigsen 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.
- Emami 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.
- 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.
- Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- Rigoard 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.
- Shiri 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/0125 Faraz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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