Clinical trial NCT05794347: Traction in Vertical Sitting Position Versus Supine Lying Position in Patients of Chronic Radicular Low Back Pain
Official title: Effects of Vertical Sitting Versus Supine Lying Traction on Pain, Range of Motion and Function in Patients With Chronic Radicular Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
Chronic pain
Traction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: follow up at 12th week
measure: Numeric Pain Rating Scale
timeFrame: follow up at 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Gojra
country: Pakistan
facility: Al-Barkat Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: uneeb ur Rehman, MS*
role: PRINCIPAL_INVESTIGATOR
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