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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03621878
Other study ID # IRB-2014-04-321
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2015
Est. completion date March 30, 2018

Study information

Verified date February 2023
Source Imam Abdulrahman Bin Faisal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.


Description:

Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session. Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date March 30, 2018
Est. primary completion date November 28, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with lumbosacral radiculopathy with dominant peripheral sensitization - patients with unilateral leg pain. - patient S-LANSS score > 12, - negative sensory and motor examination. - positive neural tissue provocation tests (straight leg raising test, slump test). - adult. - pain duration of more than 3 months. Exclusion Criteria: - S-LANSS score = 12, - motor or sensory deficits, - history of back or lower extremity surgeries, - bilateral referred pain, - patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neural mobilization exercises -Tensioner technique
Exercise aiming to lengthen the neural structure using more than one joint.
Neural mobilization exercises -Slider technique
Exercise aiming to slide/glide the neural structure using more than one joint.
Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy device aiming to decrease patient's symptoms.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mohammed Al-Ghamdi

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain) The measurements were taken at days "0,1,5,12"
Primary Hip Flexion Range of Motion (Symptomatic Side) Change in Hip flexion range of motion during straight leg raising (symptomatic side) The measurements were taken at days "0,1,5,12"
Primary Knee Flexion Range of Motion (Symptomatic Side) Change in Knee flexion range of motion during slump (symptomatic side) The measurements were taken at days "0,1,5,12"
Primary Hip Flexion Range of Motion (Asymptomatic Side) Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side) The measurements were taken at days "0,1,5,12"
Primary Knee Flexion Range of Motion (Asymptomatic Side) Change in Knee flexion range of motion during slump (Asymptomatic side) The measurements were taken at days "0,1,5,12"
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