Clinical trial NCT06727747: Effect of Cervical Traction on Balance in Cervical Radiculopathy
Official title: Effect of Cervical Traction on Balance Parameters in Patients with Cervical Radiculopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Balance Disorders
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Stabilometric balance assessment 1
timeFrame: Up to 6 months
measure: Stabilometric balance assessment 2
timeFrame: Up to 6 months
measure: Stabilometric balance assessment 3
timeFrame: Up to 6 months.
measure: Stabilometric balance assessment 4
timeFrame: Up to 6 months
measure: Stabilometric balance assessment 5
timeFrame: Up to 6 months
measure: Clinical balance assessment
timeFrame: Up to 6 months.
Secondary outcomes:
measure: Sociodemographic characteristics 1
timeFrame: Baseline.
measure: Sociodemographic characteristics 2
timeFrame: Baseline.
measure: Sociodemographic characteristics 3
timeFrame: Baseline.
measure: Sociodemographic characteristics 4
timeFrame: Baseline.
measure: Sociodemographic characteristics 5
timeFrame: Baseline.
measure: Sociodemographic characteristics 6
timeFrame: Baseline.
measure: Duration of CR
timeFrame: Baseline.
measure: Side of CR
timeFrame: Baseline.
measure: Intensity of CR
timeFrame: Baseline.
measure: • Body Mass Index
timeFrame: Baseline.
measure: Cervical range of motion (ROM)
timeFrame: Up to 6 months.
measure: Cervical proprioception
timeFrame: Up to 6 months.
measure: Cervical muscles strength
timeFrame: Up to 6 months.
measure: Handgrip strength (HGS)
timeFrame: Up to 6 months.
measure: Neck disability assessment
timeFrame: Up to 6 months.
measure: Psychological status assessment
timeFrame: Up to 6 months.
measure: Quality of life (QoL)
timeFrame: Up to 6 months.
measure: Kinesiophobia assessment
timeFrame: Baseline.
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Faculty of Medicine of Monastir
Study officials:
affiliation: University of Monastir, Faculty of Medicine
name: Anis Jellad, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jellad A, Ben Salah Z, Boudokhane S, Migaou H, Bahri I, Rejeb N. The value of intermittent cervical traction in recent cervical radiculopathy. Ann Phys Rehabil Med. 2009 Nov;52(9):638-52. doi: 10.1016/j.rehab.2009.07.035. Epub 2009 Oct 8. English, French.
citation: Jellad A, Kalai A, Abbes I, Jguirim M, Boudokhane S, Salah Frih ZB, Bedoui MH. The effect of cervical traction on stabilometric parameters in cervical radiculopathy patients: A randomized crossover study. J Back Musculoskelet Rehabil. 2024;37(4):1031-1040. doi: 10.3233/BMR-230270.