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Clinical Trials/NCT04598113
NCT04598113
Completed
N/A

The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)

University of Monastir1 site in 1 country20 target enrollmentNovember 7, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Radiculopathy
Sponsor
University of Monastir
Enrollment
20
Locations
1
Primary Endpoint
Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction.

Main outcome measures are balance parameters (force platform).

Detailed Description

A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.

Registry
clinicaltrials.gov
Start Date
November 7, 2020
End Date
March 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anis Jellad

Professor

University of Monastir

Eligibility Criteria

Inclusion Criteria

  • Unilateral cervical radiculopathy of greater than three months

Exclusion Criteria

  • History of surgery or bone-ligament damage to the cervical spine
  • Neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance
  • Inner ear and vestibular pathology
  • Worsening of pain or intolerance in the manual cervical traction test

Outcomes

Primary Outcomes

Change in static posturographic parameters: The center of pressure (CoP) movement: sway area

Time Frame: The CoP sway area assessment is done just before the intervention and 5 minutes after.

The CoP sway area (cm2) correspond to the the area which encloses the data points of the trajectory in relation with the body movement. The CoP sway area is assessed in two conditions (with open then closed eyes)

Change in static posturographic parameters: The Romberg quotient

Time Frame: The Romberg quotient assessment is done just before the intervention and 5 minutes after.

The Romberg quotient correpond to the Ratio between Closed and Open Eyes Values of the previous parameters.

Change in static posturographic parameters: CoP position

Time Frame: The CoP position assessment is done just before the intervention and 5 minutes after.

The CoP position correspond to the location side in the frontal plan (left or right) and in the sagittal plan (anterior or posterior). The CoP position is assessed in two conditions (with open then closed eyes)

Change in static posturographic parameters: The CoP displacement amplitude

Time Frame: The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after.

The CoP displacement amplitude (cm) in the anterior-posterior and medial-lateral trajectory correspond to the amount of body movement during a certain time interval in both trajectories. The CoP displacement amplitude is assessed in two conditions (with open then closed eyes)

Change in static posturographic parameters: The Cop velocity

Time Frame: The Cop velocity assessment is done just before the intervention and 5 minutes after.

The Cop velocity (cm/s) correspond to the velocity of movement of the body. The CoP velocity is assessed in two conditions (with open then closed eyes)

Secondary Outcomes

  • Change in grip strength (Kg)(The measure is done just before the intervention and 5 minutes after)
  • Change in pain intensity(The pain assessement is done just before the intervention and 5 minutes after)

Study Sites (1)

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