Effects of Different Positions on Mechanical Traction Outcome

NCT ID: NCT06812338

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-specific Low Back Pain Lumbar Traction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supine Participants

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

Group Type ACTIVE_COMPARATOR

mechanical traction

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

mechanical traction

Intervention Type 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

Side-lying Participants

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

Group Type ACTIVE_COMPARATOR

mechanical traction

Intervention Type 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

Interventions

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mechanical traction

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Mshari Saleh Alghadier

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Waleed S.E. Mahmoud, Doctoral in Physical therapy

Role: CONTACT

+966-56-311-4324

References

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Other Identifiers

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RHPT/024/020

Identifier Type: -

Identifier Source: org_study_id

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