Effect of Cervical Traction on Balance in Cervical Radiculopathy

Not Applicable

Completed

• Conditions: Cervical Radiculopathy; Balance Disorders

• Registration Number: NCT06727747
• Lead Sponsor: University of Monastir

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 Timeline

• Study Start: 2023-02-10
• Primary Completion: 2023-06-21
• Study Completion: 2023-12-30
• Study First Submitted: 2024-10-14
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stabilometric balance assessment 1	Up to 6 months	Center of pressure of the foot sway area (Cop/SA) (mm ²)
Stabilometric balance assessment 2	Up to 6 months	The lateral displacement length of the center of pressure of the foot (LD) (mm)
Stabilometric balance assessment 3	Up to 6 months.	The anteroposterior displacement length of the center of pressure of the foot (AD) (mm)
Stabilometric balance assessment 4	Up to 6 months	The lateral displacement velocity (LV) of the center of pressure of the foot (mm/s)
Stabilometric balance assessment 5	Up to 6 months	The anteroposterior velocity (AV) of the dispalcement of the center of pressure of the foot(mm/s)
Clinical balance assessment	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 Outcome Measures

Name	Time	Method
Sociodemographic characteristics 3	Baseline.	Medical History (Hypertension, diabetes, others)
Sociodemographic characteristics 4	Baseline.	Occupation (Employed, unemployed, retired)
Sociodemographic characteristics 1	Baseline.	• Age (years)
Sociodemographic characteristics 2	Baseline.	Sex (Male or Female)
Sociodemographic characteristics 5	Baseline.	Type of Occupation: Shift work (office work, secretary) or manual labor (heavy manual work, carrying loads)
Sociodemographic characteristics 6	Baseline.	Socioeconomic Level: Poor if the salary is below the guaranteed minimum wage (SMIG : around 400 Tunisian Dinars per month) , Average if the salary is between SMIG and three times SMIG, Good if it is more than three times SMIG.
Side of CR	Baseline.	The side of CR: Right, left, or bilateral
Duration of CR	Baseline.	The duration of CR is the length of radicular pain evolution in months.
Intensity of CR	Baseline.	The intensity of radicular pain was assessed using a Visual Analog Scale (VAS) scored out of 100.
• Body Mass Index	Baseline.	• Body Mass Index (BMI) (kg/m²)
Cervical range of motion (ROM)	Up to 6 months.	Cervical ROM was measured using the Cervical Range-of-Motion Instrument (CROM; Performance Attainment Associates, St Paul, MN). With its three inclinometers, the CROM device is a useful clinical instrument for measuring the cervical spine's active mobility in flexion, extension, rotation, and lateral flexion.
Cervical proprioception	Up to 6 months.	Cervical proprioception was assessed using the CROM device. Patient wearing a CROM device is instructed to maintain a neutral head position while sitting (reference position). Patient is asked to close his eyes and move his head passively before returning it to the reference position by the examiner. The angle inaccuracy is measured in degrees by the examiner. The flexion and extension tests are run .
Cervical muscles strength	Up to 6 months.	Cervical muscles strength was measured using a handheld isometric dynamometer (MicroFET2; Hoggan Health Industries). Measurements were reported in Newton. To assess the strength of the flexor muscles, the dynamometer is placed on the forehead, while for the extensor muscles, it is placed at the back of the head
Handgrip strength (HGS)	Up to 6 months.	HGS was measured using the Jamar hydraulic handheld dynamometer (Lafayette Instrument Company, USA) and was reported in kilograms.
Neck disability assessment	Up to 6 months.	The Neck disability index (NDI), a reliable instrument used in clinical practice, was used to assess patients' activities of daily living . It includes 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation) each scored from 0 (no disability) to 5 (total disability). The total score is 50 , a higher score indicates a higher disability. The NDI is expressed by percentage. The Arabic version of NDI was delivered to patients.
Psychological status assessment	Up to 6 months.	The anxiety and depression profiles were assessed using the Hospital Anxiety and Depression scale (HAD). A validated Arabic version of the scale was used. The HAD includes 14 items (7 for anxiety and 7 for depression) rated from 0 to 3 each. The maximum score is 21 for each symptom, and a higher score indicates a poor psychological status . A score less than 7 indicates no depression or anxiety, a score of 8-10 indicates doubtful cases, and a score higher than 11 indicates a certain symptomatology.
Quality of life (QoL)	Up to 6 months.	The participants' QoL was assessed using the World Health Organization quality of life (WHOQOL-BREF) questionnaire with 4 domains: physical health, psychological, social relationships, and environment. Each domain is reported in percentages, with a higher score indicating better QoL, and a lower score indicating poor QoL.
Kinesiophobia assessment	Baseline.	The Tampa Scale for Kinesiophobia (TSK) was used to evaluate the kinesiphobia. An Arabic version was administered to patients. The TSK includes 17 items rated from 1 to 4 each, with a total score ranging from 17 to 68. Higher scores reflect greater levels of movement-related fear, and a score higher than 37 indicates the presence of kinesiophobia.

Trial Locations

Locations (1)

Faculty of Medicine of Monastir; 🇹🇳 Monastir, Tunisia