Clinical trial NCT06339931: Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.
Official title: Effects of Lumber Spine Mobilization, Leg Movement, and Spinal Traction With and Without Belt in Patients With Lumber Radiculopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: Lumber Radiculopathy
Low Back Pain
Quality of Life
Traction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 44
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: Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.

Detailed description: Low back pain (LBP) is one of the primary causes of disability worldwide. Most people-between 50% and 80%-experience LBP at some point in their life. It limits the ability to perform daily activities, such as walking, standing, or lifting objects. It can also lead to decreased mobility, reduced work productivity, and increased healthcare costs. Radiating pain is commonly caused by lumbar intervertebral disk abnormalities, which are linked with nerve root irritation and affect 3% to 10% of people with generalized low back pain. Sciatica, another name for lumbar radiculopathy, is a disorder marked by pain, weakness, numbness, or tingling sensations that radiate down the lower back along a nerve root, frequently into the buttock, thigh, and lower leg. One or more lumbar nerve roots are usually compressed, irritated, or inflamed as a reason.

Eligibility criteria: Inclusion Criteria:

* Age of 16-50 years of both sexes, unilateral radiculopathy in the distribution of specific nerve with positive straight leg raise (SLR).
* Mild to moderate disability and pain on a scale of NPRS \< 7, minimum chronicity of 1 month, and maximum 6 months

Exclusion Criteria:

* Patients with previous spinal surgery'
* Any bony or soft tissue systemic disease.
* Patients with diagnosed case of co morbidities such as malignancies , RA or fractures that causes bilateral leg pain

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 4 weeks
measure: Inclinometer
timeFrame: 4 weeks
measure: Oswestry Disability Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bhalwal
country: Pakistan
facility: Atta Jaspal Hospital and ortho trauma center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Shakil Ur Rehman
role: PRINCIPAL_INVESTIGATOR
References: