Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

NCT ID: NCT04598113

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-07
• Study Completion Date: 2021-03-20

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.

Conditions

Cervical Radiculopathy; Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Effective Traction/Sham Traction

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

Group Type: ACTIVE_COMPARATOR

Cervical Traction Device

Intervention Type: 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 Traction/Effective Traction

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

Group Type: SHAM_COMPARATOR

Cervical Traction Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Anis Jellad

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Physical Medicine and rehabilitation Department

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

CTB

Identifier Type: -

Identifier Source: org_study_id