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

NCT ID: NCT05794347

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2023-08-25

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.

Detailed Description

CRLBP of the lumbosacral region is a disorder that is closely linked with socioeconomic consequences. The incidence of lower back pain among workers is approximately 13%. Out of which, CRLBP is responsible for 11%. In the lumbosacral region, radicular pain has an occurrence rate of 10 % to 25%. Key interventions by physical therapists involve pain relieving modalities, stretching, muscle conditioning, lumbar traction, and awareness about correct postures that lead to useful exercises. As the reason behind the radicular low back pain is the spinal nerve compression due to the spinal canal impingement, the lumbar traction lightens the pain through vertebral separation producing decompression on the pressed nerve. Radicular low back pain shows diverse symptoms, it can be self-limiting, staying only for a short interval with no aftereffects, or can be a key concern behind long-term disability and work loss.

The narrative on the effectiveness of vertical traction as a component of physical therapy modalities is contradictory. Despite the fact that lumbar traction has been preferred over other methods for the treatment of lumbar disk disorders, it is usually not advised in the treatment of acute low back pain because of the efficiency of more active treatment options.

The aim 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 radicular low back pain. This study may help physiotherapists to have an estimate of the best possible position for applying traction in patients with radicular low back pain. The conclusion of this study might provide therapists with an optimum traction treatment protocol for CRLBP.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group-A (Vertical sitting traction)

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

Group Type: EXPERIMENTAL

Traction

Intervention Type: OTHER

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

Group-B (supine lying traction)

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.

Group Type: ACTIVE_COMPARATOR

Traction

Intervention Type: OTHER

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

Interventions

Traction

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

uneeb ur Rehman, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Al-Barkat Hospital

Gojra, Punjab Province, Pakistan

Countries

Pakistan

References

Balague F, Nordin M, Sheikhzadeh A, Echegoyen AC, Brisby H, Hoogewoud HM, Fredman P, Skovron ML. Recovery of severe sciatica. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2516-24. doi: 10.1097/00007632-199912010-00014.

Reference Type: BACKGROUND

PMID: 10626315 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7500752 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29309314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19255792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19282797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18188660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20433733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20421859 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8434332 (View on PubMed)

Other Identifiers

REC/RCR & AHS/23/0116

Identifier Type: -

Identifier Source: org_study_id