Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

NCT04598113 | Completed

• 1 other identifier: CTB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Radiculopathy; Vertigo

Keywords

Cervical Radiculopathy; Vertigo; Traction; Balance Postural

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in pain intensity

  The pain assessement is done just before the intervention and 5 minutes after

• Change in grip strength (Kg)

  The measure is done just before the intervention and 5 minutes after

Other Outcomes (4)

• The Brief Best test

  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)

  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

  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.

Study Arms (2)

Effective Traction/Sham Traction

ACTIVE COMPARATOR

Group of patients treated firstly with Effective Traction then with Sham Traction

Device: Cervical Traction Device

Sham Traction/Effective Traction

SHAM COMPARATOR

Group of patients treated firstly with Sham Traction then with Effective Traction

Device: Cervical Traction Device

Interventions

Cervical Traction Device 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.

Effective Traction/Sham Traction; Sham Traction/Effective Traction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral cervical radiculopathy of greater than three months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Physical Medicine and rehabilitation Department

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Radiculopathy; Vertigo

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant is treated with the same traction devise in the two interventions with just a traction intensity difference. The care provider who manipulate the traction device can't be blinded to allocation The investigator (performing balance tests) is blinded to the intervention type The outcome assessor is blinded to allocation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 22, 2020
• Study Start: November 7, 2020
• Primary Completion: March 13, 2021
• Study Completion: March 20, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

TU (1)