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

Primary Purpose

Mechanical Low Back Pain, Paraspinal Muscles, Muscle Stretching Exercises

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Muscle endurance training (MET)
Conventional Treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Zohra Shafi Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Muscle endurance training (MET)

Conventional Treatment

Arm Description

Outcomes

Primary Outcome Measures

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)
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2021
Last Updated
April 4, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05052840
Brief Title
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain
Official Title
Effects of Back Muscles Endurance Training on Pain, Disability, Endurance and Lumbar Flexibility in Patients With Chronic Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
February 13, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain, Paraspinal Muscles, Muscle Stretching Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle endurance training (MET)
Arm Type
Experimental
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Muscle endurance training (MET)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
NUMERIC PAIN RATING SCALE
Description
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)
Time Frame
6 weeks
Title
REVISED OSWESTERY DISABILITY INDEX (RODQ)
Description
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.
Time Frame
6 weeks
Title
PRONE DOUBLE STRAIGHT-LEG RAISE TEST
Description
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
Time Frame
6 weeks
Title
MODIFIED SCHOBER'S TEST
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zohra Shafi Free Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29573871
Citation
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.
Results Reference
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PubMed Identifier
30252425
Citation
Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
Results Reference
background
PubMed Identifier
26487293
Citation
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.
Results Reference
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PubMed Identifier
29067082
Citation
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.
Results Reference
background
PubMed Identifier
29573870
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.
Results Reference
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PubMed Identifier
25456443
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.
Results Reference
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PubMed Identifier
27408698
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. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain

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