Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain

Mechanical Low Back Pain Clinical Trial

Official title:

Effects of Back Muscles Endurance Training on Pain, Disability, Endurance and Lumbar Flexibility in Patients With Chronic Mechanical Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052840
• Other study ID #: REC/Lhr/0125 Faraz
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 25, 2022
• Est. primary completion date: February 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain
• Muscle Stretching Exercises
• Paraspinal Muscles

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Pakistan	Zohra Shafi Free Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View Citation

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. Version 2. F1000Res. 2016 Jun 28 [revised 2016 Jan 1];5. pii: F1000 Faculty Rev-1530. eCollection 2016. Review. — View Citation

Buchbinder R, van Tulder M, Öberg 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. — View Citation

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. — View Citation

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. Review. — View Citation

Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49. pii: S0034-89102015000100408. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. Review. — View Citation

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. — View Citation

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. — View Citation

Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 weeks
Primary	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.	6 weeks
Primary	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	6 weeks
Primary	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	6 weeks