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

NCT05052840 | Completed DMC

• 1 other identifier: REC/Lhr/0125 Faraz
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Low Back Pain; Paraspinal Muscles; Muscle Stretching Exercises

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Muscle endurance training (MET)

EXPERIMENTAL

Other: Muscle endurance training (MET); Other: Conventional Treatment

Conventional Treatment

ACTIVE COMPARATOR

Other: Conventional Treatment

Interventions

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.

Muscle endurance training (MET)

Conventional Treatment OTHER

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.

Conventional Treatment; Muscle endurance training (MET)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Zohra Shafi Free Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 29573871 BACKGROUND

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

  PMID: 30252425 BACKGROUND

• 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.

  PMID: 26487293 BACKGROUND

• 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.

  PMID: 29067082 BACKGROUND

• 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.

  PMID: 29573870 BACKGROUND

• 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.

  PMID: 25456443 BACKGROUND

• 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.

  PMID: 27408698 BACKGROUND

• 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.

  PMID: 30077486 BACKGROUND

• 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.

  PMID: 29053873 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saima Zahid, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: September 13, 2021
• Primary Completion: February 13, 2022
• Study Completion: February 25, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)