Clinical trial NCT04598113: Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients
Official title: The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Vertigo
Keywords: Cervical Radiculopathy
Vertigo
Traction
Balance Postural
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
timeFrame: The CoP sway area assessment is done just before the intervention and 5 minutes after.
measure: Change in static posturographic parameters: The CoP displacement amplitude
timeFrame: The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after.
measure: Change in static posturographic parameters: The Cop velocity
timeFrame: The Cop velocity assessment is done just before the intervention and 5 minutes after.
measure: Change in static posturographic parameters: The Romberg quotient
timeFrame: The Romberg quotient assessment is done just before the intervention and 5 minutes after.
measure: Change in static posturographic parameters: CoP position
timeFrame: The CoP position assessment is done just before the intervention and 5 minutes after.
Secondary outcomes:
measure: Change in pain intensity
timeFrame: The pain assessement is done just before the intervention and 5 minutes after
measure: Change in grip strength (Kg)
timeFrame: The measure is done just before the intervention and 5 minutes after
Other outcomes:
measure: The Brief Best test
timeFrame: 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.
measure: Neck Disability Index (NDI)
timeFrame: 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.
measure: Hospital Anxiety and Depression scale
timeFrame: 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.
measure: The short form (36) health survey: SF-36
timeFrame: 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.
Locations:
city: Monastir
country: Tunisia
facility: Physical Medicine and rehabilitation Department
Study officials:
References: