Effects of Different Positions on Mechanical Traction Outcome

NCT06812338 | Not Yet Recruiting

• 1 other identifier: RHPT/024/020
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our primary purpose for this study is to investigate the effect of different positions during traction on pain, function, and range of motion in adults with non-specific low back pain.

Conditions

Non-specific Low Back Pain; Lumbar Traction

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) Arabic version

  assesses the impact of back pain on daily life across 10 sections. Each section covers different activities and aspects of daily living. The responses are scored from 0 (no impact) to 5 (maximum impact), with higher scores indicating greater disability

  from baseline to the end of the 6th week

Secondary Outcomes (3)

• International Physical Activity Questionnaire (IPAQ) arabic version

  from baseline to the end of the 6th week

• Numerical pain rating scale (NPRS)

  from baseline to the end of the 6th week

• Finger-to-floor test (FFT)

  from baseline to the end of the 6th week

Study Arms (3)

Supine Participants

ACTIVE COMPARATOR

Participants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90°

Device: mechanical traction

Prone Participants

ACTIVE COMPARATOR

will lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis

Device: mechanical traction

Side-lying Participants

ACTIVE COMPARATOR

will lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between their knees

Device: mechanical traction

Interventions

mechanical traction DEVICE

Participants will receive traction therapy as follows: force will start at 25% of Body weight, gradually increasing until the tolerance for pulling is reached with maximum of 50% of body weight. The session will be 15 minutes long (1min for acceleration, 13 min application, 1min deceleration); it will be intermittent with ratio of 30 s on and 10s off

Prone Participants; Side-lying Participants; Supine Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18-65 years of age
• Non specific LBP persisted for more than 12 weeks
• At least 4/10 on NPRS

You may not qualify if:

• Vertebral fractures
• Axial spondylarthritis
• Aauda equina syndrome
• Radicular pain
• Radiculopathy
• Spinal stenosis
• Spinal surgeries
• Malignancy
• Pregnancy
• Inflammatory or infectious cases of LBP

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Related Publications (36)

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Central Study Contacts

Waleed S.E. Mahmoud, Doctoral in Physical therapy

CONTACT

+966-56-311-4324; w.mahmoud@psau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: It will be a triple-armed Randomized control trial, 30 subject will be recruited and randomly allocated into the three groups (supine, prone, and side-lying) using sealed envelope method, same treatment will be delivered with difference in positioning only, Supine Participants will lie in supine position with legs supported on a stool adjusted for hip and knee flexion to be at 90°, Prone Participants will lie in prone position with a pillow underneath their abdomen and a harness attached to the chest, and pelvis. Side-lying Participants will lie on the contralateral side of pain, with his hip flexed at 80°, and a pillow between his knees.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: February 15, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share