Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.

Lumbar Radiculopathy Clinical Trial

Official title:

Effects of Lumber Spine Mobilization, Leg Movement, and Spinal Traction With and Without Belt in Patients With Lumber Radiculopathy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339931
• Other study ID #: REC/RCR &AHS/23/0181
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Shakil Ur Rehman, PhD
• Phone: 03207866611
• Email: shakil.urrehman[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Other:
• SMWLM combined Spinal traction with belt
Group A, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Wrap the traction belt around both your hips and the proximal aspect of the patient's thighs.Apply traction by leaning backward and shifting your body weight onto your posterior leg.
• SMWLM combined spinal traction without belt
Group B, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Manual traction is applied by placing the patient over a rolled pillow while lying sideways. The roll should be 6-8 inches in diameter and should be placed at the level of the spine where the traction or separation is to occur. Pull the patient's legs toward you as you lean your body backward to apply a traction force.

Locations

Country	Name	City	State
Pakistan	Atta Jaspal Hospital and ortho trauma center	Bhalwal	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric pain rating scale	The NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain ("no pain") to '10' for the most extreme levels of pain ("pain as severe as you can imagine")	4 weeks
Primary	Inclinometer	Bubble inclinometer for measuring joint range of motion	4 weeks
Primary	Oswestry Disability Index	Gold standard of low back pain functional outcome tools	4 weeks