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Completed

NCT Number: NCT05794347

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Barkat Hospital

Gojra, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traction

Other

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: follow up at 12th week

    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

  2. Numeric Pain Rating Scale

    Time frame: follow up at 12th week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Vertical Sitting Versus Supine Lying Traction on Pain, Range of Motion and Function in Patients With Chronic Radicular Low Back Pain

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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