Non Pain Contingent Spine Rehabilitation Therapy in Chronic Low Back Pain

NCT04619134 | Completed

• 1 other identifier: REC/00673 Fariha Altaf
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to determine effects of non pain contingent spine rehabilitation in chronic low back pain.A Randomized controlled trial will be conducted at Railway general hospital. Sample size will be 32.Participants will be divided in two groups, 16 participants in group A will receive Non pain contingent spine rehabilitation (NCSR) therapy and 16 Group B will receive conventional physical therapy. The study duration will be six months. Purposive non probability sampling technique will be applied.

Conditions

Low Back Pain

Keywords

Low Back Pain; Non Pain Contingent Spine Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  Visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words "no pain" and "worst pain" at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity. Changes from the baseline will be measured and at 4th week and then at 6th week

  6th week

• Functional Disability: Oswestry Disability Index

  The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for the evaluation and treatment of LBP and it is valid, reliable. Changes from the baseline will be measured and at 4th week and then at 6th week

  6th week

Secondary Outcomes (5)

• Lumbar Range of Motion

  6th week

• Shirado test: to assess isometric endurance of trunk flexors

  6th week

• Ito test: to evaluate isometric endurance of trunk extensors

  6th week

• Lifting endurance

  6th week

• Fear Avoidance Belief Questionnaire

  6th week

Study Arms (2)

NCSR Program

EXPERIMENTAL

Non Pain Contingent Spinal Rehabilitation

Other: NCSR Program

Conventional Physical therapy

ACTIVE COMPARATOR

Conventional Physical Therapy

Other: conventional physical therapy

Interventions

NCSR Program OTHER

flexibility exercise,strengthening exercise,dynamic strengthening exercise,endurance training,counselling session

NCSR Program

conventional physical therapy OTHER

hot pack,flexibility training,strengthening exercise.

Conventional Physical therapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with non-specific chronic low back pain(\>3months)

You may not qualify if:

• Spinal surgery
• Compression Fracture
• Disc Herniation
• Cauda equina
• Pregnancy
• Cancer
• Progressive neurological disorder
• Any Psychological disorder

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (13)

• Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.

  PMID: 27417610 BACKGROUND

• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

  PMID: 28192789 BACKGROUND

• Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.

  PMID: 26000680 BACKGROUND

• Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015 Mar;27(3):619-22. doi: 10.1589/jpts.27.619. Epub 2015 Mar 31.

  PMID: 25931693 BACKGROUND

• Bhadauria EA, Gurudut P. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial. J Exerc Rehabil. 2017 Aug 29;13(4):477-485. doi: 10.12965/jer.1734972.486. eCollection 2017 Aug.

  PMID: 29114516 BACKGROUND

• Cho I, Jeon C, Lee S, Lee D, Hwangbo G. Effects of lumbar stabilization exercise on functional disability and lumbar lordosis angle in patients with chronic low back pain. J Phys Ther Sci. 2015 Jun;27(6):1983-5. doi: 10.1589/jpts.27.1983. Epub 2015 Jun 30.

  PMID: 26180363 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

• Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.

  PMID: 23411647 BACKGROUND

• Ito T, Shirado O, Suzuki H, Takahashi M, Kaneda K, Strax TE. Lumbar trunk muscle endurance testing: an inexpensive alternative to a machine for evaluation. Arch Phys Med Rehabil. 1996 Jan;77(1):75-9. doi: 10.1016/s0003-9993(96)90224-5.

  PMID: 8554479 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Saur PM, Ensink FB, Frese K, Seeger D, Hildebrandt J. Lumbar range of motion: reliability and validity of the inclinometer technique in the clinical measurement of trunk flexibility. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1332-8. doi: 10.1097/00007632-199606010-00011.

  PMID: 8725925 BACKGROUND

• Williamson E. Fear Avoidance Beliefs Questionnaire (FABQ). Aust J Physiother. 2006;52(2):149. doi: 10.1016/s0004-9514(06)70052-6. No abstract available.

  PMID: 16805041 BACKGROUND

• Jensen LD, Maribo T, Schiottz-Christensen B, Madsen FH, Gonge B, Christensen M, Frost P. Counselling low-back-pain patients in secondary healthcare: a randomised trial addressing experienced workplace barriers and physical activity. Occup Environ Med. 2012 Jan;69(1):21-8. doi: 10.1136/oem.2010.064055. Epub 2011 May 19.

  PMID: 21597108 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

• Maria Khalid, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: December 1, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)