Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

Not Applicable

Completed

• Conditions: Cervical Radiculopathy; Vertigo
• Interventions: Device: Cervical Traction Device

• Registration Number: NCT04598113
• Lead Sponsor: University of Monastir

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.

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2020-11-07
• Primary Completion: 2021-03-13
• Study Completion: 2021-03-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-17
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Traction/Effective Traction	Cervical Traction Device	Group of patients treated firstly with Sham Traction then with Effective Traction
Effective Traction/Sham Traction	Cervical Traction Device	Group of patients treated firstly with Effective Traction then with Sham Traction

Primary Outcome Measures

Name	Time	Method
Change in static posturographic parameters: The center of pressure (CoP) movement: sway area	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change in grip strength (Kg)	The measure is done just before the intervention and 5 minutes after	The grip strength is measured using Jamar Hydraulic Hand Dynamometer
Change in pain intensity	The pain assessement is done just before the intervention and 5 minutes after	The pain is assessed using a visual analog scale(VAS) /100 mm (minimum 0 mm and maximum 100 mm). The higher the score the worse the patient's pain.

Trial Locations

Locations (1)

Physical Medicine and rehabilitation Department; 🇹🇳 Monastir, Tunisia