- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07786402
Clinical Outcomes of Prone and Supine Lumbar Traction Matched to Mechanical Bias in Flexion and Extension Subgroups With Lumbosacral Radiculopathy
Clinical Outcomes of Prone and Supine Lumbar Traction Matched to Mechanical Bias in Flexion and Extension Subgroups With Lumbosacral Radiculopathy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Atef abdulalim nadier, Assistant professor
- Phone Number: +201003867064
- Email: a.nadier@ammanu.edu.jo
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Acute and subacute lumbosacral disc herniation with radiculopathy.
- Positive Straight leg raising test or Slump test.
Exclusion Criteria:
- Spondylolisthesis, prior spinal surgery, "Red Flags" (Cauda Equina, malignancy), or a non-mechanical response to repeated movements and patients with LBP without radiculopathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A) Extension bias, prone traction
Mechanical intermittent traction will done for 15 minutes with patient in prone position, after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Prone on elbow press up exercise . Infrared radiation on back before traction |
Press up on elbow exercise traction from prone.
|
|
Experimental: B) Extension bias, supine traction
Mechanical intermittent traction will done for 15 minutes with patient in supine position, after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on back before the traction. Press up on elbow exercise . |
Press up on elbow exercise.
traction from supine
|
|
Experimental: C) Flexion bias, supine traction
Mechanical intermittent traction will done for 15 minutes with patient in supine position(matches flexion bias), after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on the back before the traction for 10 minutes. Knee to chest exercise for 2 minutes before the session . |
Traction from supine with flexion bias exercise knee to chest exercise for 2 minutes
|
|
Experimental: D) Flexion bias, prone traction
Mechanical intermittent traction will done for 15 minutes with patient in prone position(mismatches flexion bias), after release the patient let wrest for 2 minutes then asked to walking for 1 minutes without immediate sitting post traction period. Infrared on the back before the traction for 10 minutes. Knee to chest exercise for 2 minutes before the session . |
Traction from prone with flexion bias exercise knee to chest exercise for 2 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical pain scale (NPRS)
Time Frame: Pain intensity was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Pain (lower limb radiating pain)
|
Pain intensity was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
|
Oswestry back scale (ODI)
Time Frame: Patients completed the ODI questionnaire at baseline during their initial clinical evaluation. A subsequent assessment was conducted upon completion of the 12-session intervention protocol (representing the one-month follow-up)
|
Functional questionnaire for back disability
|
Patients completed the ODI questionnaire at baseline during their initial clinical evaluation. A subsequent assessment was conducted upon completion of the 12-session intervention protocol (representing the one-month follow-up)
|
|
Hip flexion Angle
Time Frame: Hip flexion Angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Hip flexion Angle during SLR test is also used to measure neural tension improvements for extension bias groups (by digital inclinometer)
|
Hip flexion Angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
|
Knee extension angle
Time Frame: Knee extension angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Knee extension angle with active knee extension during slump test was used for flexion bias groups (to measure how many degrees the knee is away from full extension when the leg pain starts).
|
Knee extension angle was assessed at baseline (during the initial assessment) and again after completion of the 12th treatment session (one-month follow-up)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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