Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Vertigo; Cervical Radiculopathy
• Intervention / Treatment: Device: Cervical Traction Device

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Physical Medicine and Rehabilitation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Effective Traction/Sham Traction; Group of patients treated firstly with Effective Traction then with Sham Traction	Device: Cervical Traction Device; 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.
SHAM_COMPARATOR: Sham Traction/Effective Traction; Group of patients treated firstly with Sham Traction then with Effective Traction	Device: Cervical Traction Device; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Brief Best test	Clinical test to assess the balance capacity during standing and walking.	The test is performed only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.
Neck Disability Index (NDI)	A self-administered questionnaire used to assess the self-rated disability. It contains 10 sections scored from 0 to 5 each. The total score range from 0 to 50. The higher the score the higher the patient's level of disability.	The questionnaire is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.
Hospital Anxiety and Depression scale	A scale used to determine the level of anxiety and depression in patients. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each response to a question is scored from 0 to 3. The total score for anxiety and depression separately range from 0 to 21. The higher the score the more sever the patient's anxiety and depression status.	The scale is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.
The short form (36) health survey: SF-36	A questionnaire used to assess patient's health status (Quality of life). It yields an 8-scale profile of functional health and well-being scores: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), mental health (MH), and one single item scale on health transition. Score ranges from 0 to 100, with higher score indicating higher level of function and/or better health and lower score indicating lower level of function and/or bad health.	The questionnaire is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2020
• Primary Completion (ACTUAL): March 13, 2021
• Study Completion (ACTUAL): March 20, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Traction; Vertigo; Cervical Radiculopathy; Balance Postural
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Otorhinolaryngologic Diseases; Peripheral Nervous System Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Vertigo; Radiculopathy
• Other Study ID Numbers: CTB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No