Effect of Cervical Traction on Balance Parameters in Patients with Cervical Radiculopathy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Monastir
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Stabilometric balance assessment 1
Study Overview
Brief Summary
A randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy.
Authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. Three different loads of traction are compared Main outcome measures are balance parameters (clinical and stabilometric). Patients are followed for during six months.
Detailed Description
A randomized clinical trial was designed to assess the effect of cervical intermittent traction on balance parameters 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 three groups (A, B and C). Patients are treated with 2 Kg load intermittent cervical traction (A), 8 kg (B) and 12 kg (C). Patients in the three groups are treated additionnally with 12 rehabilitation sessions. Patients are assessed at baseline, at the end of the treatment (1 month), and at 3 and 6 months. Outcomes are mainly clinical balance assessment and stabilometry, and secondary, epidemiological parameters, pain intensity (VAS), cervical spine ROM and proprioception, grip strength, cervical spinal muscle strength, functional status (NDI), the psychological distress (HAD), and Quality of life All parameters are assessed at the Three follow-up points.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The clinician who screened patients for eligibility
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CR evolving for at least 3 months Well tolerated manual cervical traction test.
Exclusion Criteria
- •Rehabilitation or chiropractic treatment for head or neck pain within the previous 3 months.
- •neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance.
- •Surgery or traumatic damage to the cervical spine.
- •Ear, Nose and Throat pathology and ophthalmological disorders causing a balance disorder.
- •Diabetes at the stage of neurovegetative complications
- •Cardiac arrhythmia
- •Neurological impairments (balance disorders, motor and/or sensory deficits).
- •Severe osteoporosis or long-term treatment with corticosteroids .
Arms & Interventions
Group A
Patients in group A recieved cervical traction with 2 kg load combined with standard rehabilitation program. This group is condidered as sham because the 2 kg load does not have any effect on anatomical structures of the cervical spine.
Intervention: Cervical traction (Other)
Group A
Patients in group A recieved cervical traction with 2 kg load combined with standard rehabilitation program. This group is condidered as sham because the 2 kg load does not have any effect on anatomical structures of the cervical spine.
Intervention: Rehabilitation (Other)
Group B
Patients in group B recieved cervical traction with 8 kg load combined with standard rehabilitation program. The traction load in this group has an effect on muscular structures of the cervical spine without any actual effect on the remaining anatomical structures (intervertabral disks, joints and ligaments).
Intervention: Cervical traction (Other)
Group B
Patients in group B recieved cervical traction with 8 kg load combined with standard rehabilitation program. The traction load in this group has an effect on muscular structures of the cervical spine without any actual effect on the remaining anatomical structures (intervertabral disks, joints and ligaments).
Intervention: Rehabilitation (Other)
Group C
Patients in group C recieved cervical traction with 12 kg load combined with standard rehabilitation program. The traction load in this group has an actual effect on muscles, intervertabral disks, joints, and ligaments of the cervical spine.
Intervention: Cervical traction (Other)
Group C
Patients in group C recieved cervical traction with 12 kg load combined with standard rehabilitation program. The traction load in this group has an actual effect on muscles, intervertabral disks, joints, and ligaments of the cervical spine.
Intervention: Rehabilitation (Other)
Outcomes
Primary Outcomes
Stabilometric balance assessment 1
Time Frame: Up to 6 months
Center of pressure of the foot sway area (Cop/SA) (mm ²)
Stabilometric balance assessment 2
Time Frame: Up to 6 months
The lateral displacement length of the center of pressure of the foot (LD) (mm)
Stabilometric balance assessment 3
Time Frame: Up to 6 months.
The anteroposterior displacement length of the center of pressure of the foot (AD) (mm)
Stabilometric balance assessment 4
Time Frame: Up to 6 months
The lateral displacement velocity (LV) of the center of pressure of the foot (mm/s)
Stabilometric balance assessment 5
Time Frame: Up to 6 months
The anteroposterior velocity (AV) of the dispalcement of the center of pressure of the foot(mm/s)
Clinical balance assessment
Time Frame: Up to 6 months.
For the clinical balance assessment, the Brief-BESTest was used. Six categories included in the test (8 scored): 1. Biomechanical constraints: Hip strength 2. Stability limits/verticality: Reach forward 3. Anticipatory postural responses: Stand on one limb: left and right each scored 4. Postural responses: Compensatory Stepping right and left each scored 5. Sensory orientation: Stance on foam with eyes closed 6. Stability in gait: Get up and Go test Each item is scored: 0 - 3 points (0 representing severe impairment and 3 representing no balance impairment). Total score = 24 points (2 items include both a R/L component)
Secondary Outcomes
- Sociodemographic characteristics 1(Baseline.)
- Sociodemographic characteristics 2(Baseline.)
- Sociodemographic characteristics 3(Baseline.)
- Sociodemographic characteristics 4(Baseline.)
- Sociodemographic characteristics 5(Baseline.)
- Sociodemographic characteristics 6(Baseline.)
- Side of CR(Baseline.)
- Duration of CR(Baseline.)
- Intensity of CR(Baseline.)
- • Body Mass Index(Baseline.)
- Cervical range of motion (ROM)(Up to 6 months.)
- Cervical proprioception(Up to 6 months.)
- Cervical muscles strength(Up to 6 months.)
- Handgrip strength (HGS)(Up to 6 months.)
- Neck disability assessment(Up to 6 months.)
- Psychological status assessment(Up to 6 months.)
- Quality of life (QoL)(Up to 6 months.)
- Kinesiophobia assessment(Baseline.)
Investigators
Anis Jellad
Professor
University of Monastir