Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Radiculopathy, Vertigo

Intervention / Treatment
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* Device: Cervical Traction Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two interventions: Effective Traction (ET) and Sham Traction (ST) Two arms: Arm 1: Effective Traction/Sham Traction (ET than ST) and Arm 2: Sham Traction/Effective Traction (ST than ET) Wash out period = 1 week
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effective Traction/Sham Traction<br>Group of patients treated firstly with Effective Traction then with Sham Traction | Device: Cervical Traction Device<br>* While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest. The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end.<br>|
| Sham Comparator: Sham Traction/Effective Traction<br>Group of patients treated firstly with Sham Traction then with Effective Traction | Device: Cervical Traction Device<br>* While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest. The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in static posturographic parameters: The center of pressure (CoP) movement: sway area | 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) | The CoP sway area assessment is done just before the intervention and 5 minutes after. | 
| Change in static posturographic parameters: The CoP displacement amplitude | 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) | The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after. | 
| Change in static posturographic parameters: The Cop velocity | 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) | The Cop velocity assessment is done just before the intervention and 5 minutes after. | 
| Change in static posturographic parameters: The Romberg quotient | The Romberg quotient correpond to the Ratio between Closed and Open Eyes Values of the previous parameters. | The Romberg quotient assessment is done just before the intervention and 5 minutes after. | 
| Change in static posturographic parameters: CoP position | 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) | The CoP position assessment is done just before the intervention and 5 minutes after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | 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. | The pain assessement is done just before the intervention and 5 minutes after | 
| Change in grip strength (Kg) | The grip strength is measured using Jamar Hydraulic Hand Dynamometer | The measure is done just before the intervention and 5 minutes after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Radiculopathy, Vertigo, Traction, Balance Postural