Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.

NCT06339931 | Completed

• 1 other identifier: REC/RCR &AHS/23/0181
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Keywords

Lumber Radiculopathy; Low Back Pain; Quality of Life; Traction

Outcome Measures

Primary Outcomes (3)

• 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

• Inclinometer

  Bubble inclinometer for measuring joint range of motion

  4 weeks

• Oswestry Disability Index

  Gold standard of low back pain functional outcome tools

  4 weeks

Study Arms (2)

SMWLM combined Spinal traction with belt

EXPERIMENTAL

Group A (Spinal traction with belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Spinal traction with belt for 10 mins.

Other: SMWLM combined Spinal traction with belt

SMWLM combined Spinal traction without belt

ACTIVE COMPARATOR

Group B (Spinal traction without belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Manual spinal traction technique without belt.

Other: SMWLM combined spinal traction without belt

Interventions

SMWLM combined Spinal traction with belt OTHER

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 with belt

SMWLM combined spinal traction without belt OTHER

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.

SMWLM combined Spinal traction without belt

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Atta Jaspal Hospital and ortho trauma center

Bhalwal, Punjab Province, 40410, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shakil Ur Rehman

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: November 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)