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Effects of Patient Education Manual in Patient With Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04600843
Recruitment Status : Completed
First Posted : October 23, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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Brief Summary:
It was a randomized clinical trial conducted to determine the effects of patient education manual on pain, range of motion and function in patient with chronic low back pain at Salamat hospital Satellite Town Gujranwala in patients with 6-month chronic low back pain who were willing to follow patient education manual. Patients were assessed for pain, disability due to backpain and lumbar ranges, at baseline, 2nd, 4th and 6th week of intervention. The SPSS 20.0 version was used to analyse data. Tests of normality were executed that whether data was normative or non-parametric, based on which outcomes were compared either using independent samples t test or Mann-Whitney test.

Condition or disease Intervention/treatment Phase
Back Disorder Other: Physical therapy with Patient education Other: Physical Therapy without patient Education Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Patient Education Manual on Pain, Range of Motion and Function in Patient With Chronic Low Back Pain Neck Pain
Actual Study Start Date : December 30, 2019
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical therapy with Patient education
Treated with proper physical therapy treatment protocol according to patient presenting condition and patient education manual
 Other: Physical therapy with Patient education
patient manual was translated and validated in Urdu which was provided to patients so that they can follow it at home
Other Name: patient education manual
Experimental: Physical Therapy without patient Education
Treated with proper physical therapy treatment protocol according to patient presenting condition
 Other: Physical Therapy without patient Education
Group B was only treated with proper physical therapy treatment protocol according to patient presenting condition


Outcome Measures
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Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 6th Week ]
    The Oswestry Disability Index (ODI) (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 tool. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: 6th Week ]
    NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").


Other Outcome Measures:
  1. GONIOMETER [ Time Frame: 6th Week ]
    A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body. We will use this to measure range of motions ROM on spine, Flexion, Extension, Rotation, Sideflexion R & L


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months chronic,
  • localized low back pain

Exclusion Criteria:

  • Patients with radicular low back pain
  • Ankylosing spondylitis
  • spinal stenosis
  • Fibromyalgia
  • 0steoprosis
  • Cognitive impairment
  • Traumatic injury
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600843


Locations
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Pakistan
Salamat Hospital,Satellite Town
Gujrānwāla, Punjab, Pakistan
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Syed Shakil Ur-Rehman, PhD Riphah International University
More Information
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Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04600843    
Other Study ID Numbers: REC/RCRS/20/1003 Mubashra
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Back Pain Exercise Therapy
Patient Education Manual
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations