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

NCT04600843 | Completed

• 1 other identifier: REC/RCRS/20/1003 Mubashra
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Disorder

Keywords

Back Pain Exercise Therapy; Patient Education Manual

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  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

  6th Week

Secondary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  6th Week

Other Outcomes (1)

• GONIOMETER

  6th Week

Study Arms (2)

Physical therapy with Patient education

EXPERIMENTAL

Treated with proper physical therapy treatment protocol according to patient presenting condition and patient education manual

Other: Physical therapy with Patient education

Physical Therapy without patient Education

EXPERIMENTAL

Treated with proper physical therapy treatment protocol according to patient presenting condition

Other: Physical Therapy without patient Education

Interventions

Physical therapy with Patient education OTHER

patient manual was translated and validated in Urdu which was provided to patients so that they can follow it at home

Also known as: patient education manual

Physical therapy with Patient education

Physical Therapy without patient Education OTHER

Group B was only treated with proper physical therapy treatment protocol according to patient presenting condition

Physical Therapy without patient Education

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• months chronic,
• localized low back pain

You may not qualify if:

• Patients with radicular low back pain
• Ankylosing spondylitis
• spinal stenosis
• Fibromyalgia
• steoprosis
• Cognitive impairment
• Traumatic injury

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Salamat Hospital,Satellite Town

Gujranwala, Punjab Province, Pakistan

Location

Related Publications (15)

• Sahin N, Karahan AY, Albayrak I. Effectiveness of physical therapy and exercise on pain and functional status in patients with chronic low back pain: a randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Aug 9;64(1):52-58. doi: 10.5606/tftrd.2018.1238. eCollection 2018 Mar.

  PMID: 31453489 BACKGROUND

• Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.

  PMID: 28631003 BACKGROUND

• Traeger AC, Lee H, Hubscher M, Skinner IW, Moseley GL, Nicholas MK, Henschke N, Refshauge KM, Blyth FM, Main CJ, Hush JM, Lo S, McAuley JH. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.

  PMID: 30398542 BACKGROUND

• Pieber K, Herceg M, Quittan M, Csapo R, Muller R, Wiesinger GF. Long-term effects of an outpatient rehabilitation program in patients with chronic recurrent low back pain. Eur Spine J. 2014 Apr;23(4):779-85. doi: 10.1007/s00586-013-3156-z. Epub 2014 Jan 11.

  PMID: 24413743 BACKGROUND

• Hanney WJ, Masaracchio M, Liu X, Kolber MJ. The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature. PLoS One. 2016 Jun 10;11(6):e0156799. doi: 10.1371/journal.pone.0156799. eCollection 2016.

  PMID: 27285608 BACKGROUND

• Medeiros FC, Costa LOP, Added MAN, Salomao EC, Costa LDCM. Longitudinal Monitoring of Patients With Chronic Low Back Pain During Physical Therapy Treatment Using the STarT Back Screening Tool. J Orthop Sports Phys Ther. 2017 May;47(5):314-323. doi: 10.2519/jospt.2017.7199. Epub 2017 Mar 29.

  PMID: 28355979 BACKGROUND

• Barbari V, Storari L, Ciuro A, Testa M. Effectiveness of communicative and educative strategies in chronic low back pain patients: A systematic review. Patient Educ Couns. 2020 May;103(5):908-929. doi: 10.1016/j.pec.2019.11.031. Epub 2019 Dec 4.

  PMID: 31839351 BACKGROUND

• Beattie PF, Silfies SP, Jordon M. The evolving role of physical therapists in the long-term management of chronic low back pain: longitudinal care using assisted self-management strategies. Braz J Phys Ther. 2016 Nov-Dec;20(6):580-591. doi: 10.1590/bjpt-rbf.2014.0180. Epub 2016 Jun 30.

  PMID: 28001268 BACKGROUND

• Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.

  PMID: 30217693 BACKGROUND

• Cherkin DC, Deyo RA, Street JH, Hunt M, Barlow W. Pitfalls of patient education. Limited success of a program for back pain in primary care. Spine (Phila Pa 1976). 1996 Feb 1;21(3):345-55. doi: 10.1097/00007632-199602010-00019.

  PMID: 8742212 BACKGROUND

• Davin S, Lapin B, Mijatovic D, Fox R, Benzel E, Stilphen M, Machado A, Katzan IL. Comparative Effectiveness of an Interdisciplinary Pain Program for Chronic Low Back Pain, Compared to Physical Therapy Alone. Spine (Phila Pa 1976). 2019 Dec 15;44(24):1715-1722. doi: 10.1097/BRS.0000000000003161.

  PMID: 31794508 BACKGROUND

• de Souza FS, Ladeira CE, Costa LOP. Adherence to Back Pain Clinical Practice Guidelines by Brazilian Physical Therapists: A Cross-sectional Study. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1251-E1258. doi: 10.1097/BRS.0000000000002190.

  PMID: 28399548 BACKGROUND

• Deutscher D, Werneke MW, Hayes D, Mioduski JE, Cook KF, Fritz JM, Woodhouse LJ, Stratford PW. Impact of Risk Adjustment on Provider Ranking for Patients With Low Back Pain Receiving Physical Therapy. J Orthop Sports Phys Ther. 2018 Aug;48(8):637-648. doi: 10.2519/jospt.2018.7981. Epub 2018 May 22.

  PMID: 29787696 BACKGROUND

• Du S, Hu L, Dong J, Xu G, Chen X, Jin S, Zhang H, Yin H. Self-management program for chronic low back pain: A systematic review and meta-analysis. Patient Educ Couns. 2017 Jan;100(1):37-49. doi: 10.1016/j.pec.2016.07.029. Epub 2016 Jul 25.

  PMID: 27554077 BACKGROUND

• Fritz JM, Kim M, Magel JS, Asche CV. Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 Mar;42(5):285-290. doi: 10.1097/BRS.0000000000001729.

  PMID: 27270641 BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities; Patient Education as Topic

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Syed Shakil Ur-Rehman, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 30, 2019
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)