Traction in Vertical Sitting Position Versus Supine Lying Position in Patients of Chronic Radicular Low Back Pain

NCT05794347 | Completed

• 1 other identifier: REC/RCR & AHS/23/0116
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine the effects of vertical sitting versus supine lying traction on pain, range of motion, and function in patients with chronic radicular low back pain (CRLBP). CRLBP is one of the major types of lower back pain and causes significant disability and reduction in quality of life in the human population. The study will be a randomized controlled trial and the study setting will be Al-Barkat Hospital Gojra . A total of 30 participants will be selected randomly employing a non-probability convenient sampling technique. Two experimental groups will be made. Group A will be given vertical traction in a sitting position and Group B will be given traction in supine lying. Both groups will receive baseline physiotherapy treatment which includes Hot-pack, TENS, and ultrasound. The Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) will be used as outcome-measuring tools for pain intensity and functional disability respectively. An inclinometer will be used to measure ROM. Measures will be taken at (0, 4th, 8th, and 12th week). Data will be analyzed by using parametric/non-parametric tests after assessing the normality. SPSS version 28.

Conditions

Low Back Pain

Keywords

low back pain; Chronic pain; Traction

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index

  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. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures

  follow up at 12th week

• Numeric Pain Rating Scale

  The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.

  follow up at 12th week

Study Arms (2)

Group-A (Vertical sitting traction)

EXPERIMENTAL

This session will be followed by the application of the continuous mechanical traction in the vertical sitting position with a belt around the chest. A total of 30 minutes session per day with 5 sessions per week for 12 weeks will be provided to the participants in this group

Other: Traction

Group-B (supine lying traction)

ACTIVE COMPARATOR

Following the conventional treatment, continuous mechanical traction will be applied in the supine lying position with a traction force equal to 50% of the total body weight. A total of 20 minutes session per day with 5 sessions per week will be provided to the participants in group B.

Other: Traction

Interventions

Traction OTHER

Continuous mechanical traction will be applied to the lumbar area in 2 different positions.

Group-A (Vertical sitting traction); Group-B (supine lying traction)

Eligibility Criteria

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

You may qualify if:

• Both genders have an age range between 20-50 years.
• Chronicity of radicular low back pain for at least 3 months
• Capable of attending physiotherapy sessions regularly (5 times a week for 12 weeks)

You may not qualify if:

• Patients with indications of spinal cord involvement (For instance; Urine or Fecal incontinency, Lack of sensation, or Limb paralysis
• Pregnant females will not be included.
• Patients with a background of spinal trauma
• Patients presenting a history of systemic disease

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Al-Barkat Hospital

Gojra, Punjab Province, 54700, Pakistan

Location

Related Publications (9)

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  PMID: 10626315 BACKGROUND

• Beurskens AJ, de Vet HC, Koke AJ, Lindeman E, Regtop W, van der Heijden GJ, Knipschild PG. Efficacy of traction for non-specific low back pain: a randomised clinical trial. Lancet. 1995 Dec 16;346(8990):1596-600. doi: 10.1016/s0140-6736(95)91930-9.

  PMID: 7500752 BACKGROUND

• Bilgilisoy Filiz M, Kilic Z, Uckun A, Cakir T, Koldas Dogan S, Toraman NF. Mechanical Traction for Lumbar Radicular Pain: Supine or Prone? A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jun;97(6):433-439. doi: 10.1097/PHM.0000000000000892.

  PMID: 29309314 BACKGROUND

• Cai C, Pua YH, Lim KC. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with mechanical lumbar traction. Eur Spine J. 2009 Apr;18(4):554-61. doi: 10.1007/s00586-009-0909-9. Epub 2009 Mar 3.

  PMID: 19255792 BACKGROUND

• Carey TS, Freburger JK, Holmes GM, Castel L, Darter J, Agans R, Kalsbeek W, Jackman A. A long way to go: practice patterns and evidence in chronic low back pain care. Spine (Phila Pa 1976). 2009 Apr 1;34(7):718-24. doi: 10.1097/BRS.0b013e31819792b0.

  PMID: 19282797 BACKGROUND

• Koldas Dogan S, Sonel Tur B, Kurtais Y, Atay MB. Comparison of three different approaches in the treatment of chronic low back pain. Clin Rheumatol. 2008 Jul;27(7):873-81. doi: 10.1007/s10067-007-0815-7. Epub 2008 Jan 11.

  PMID: 18188660 BACKGROUND

• Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.

  PMID: 20433733 BACKGROUND

• Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc herniation with associated radiculopathy: a systematic review. Spine (Phila Pa 1976). 2010 May 15;35(11):E488-504. doi: 10.1097/BRS.0b013e3181cc3f56.

  PMID: 20421859 BACKGROUND

• Hansen FR, Bendix T, Skov P, Jensen CV, Kristensen JH, Krohn L, Schioeler H. Intensive, dynamic back-muscle exercises, conventional physiotherapy, or placebo-control treatment of low-back pain. A randomized, observer-blind trial. Spine (Phila Pa 1976). 1993 Jan;18(1):98-108. doi: 10.1097/00007632-199301000-00015.

  PMID: 8434332 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Traction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• uneeb ur Rehman, MS*

  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: March 15, 2023
• First Posted: April 3, 2023
• Study Start: April 15, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 25, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)