Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598113
• Other study ID #: CTB
• Status: Completed
• Phase: N/A
• Start date: November 7, 2020
• Est. completion date: March 20, 2021

Study information

• Verified date: July 2021
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 20, 2021
• Est. primary completion date: March 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy
• Vertigo

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Physical Medicine and rehabilitation Department	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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