Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- The Visual Analog Scale for Pain
Study Overview
Brief Summary
The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial.
Detailed Description
This study, slated to be conducted across four sub-centers, including the Wangjing Hospital of the China Academy of Chinese Medical Sciences, aims to recruit 216 patients diagnosed with cervical radiculopathy. Employing a central randomization method, participants will be stratified into three groups: high-frequency manipulation, low-frequency manipulation, and cervical traction.
In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly, while the low-frequency manipulation group will receive the same intervention once a week. The cervical traction group will be subjected to cervical traction three times a week. Each group will undergo 4-week treatment with a subsequent 16-week follow-up, resulting in a total study duration of 20 weeks.
Outcomes' assessments will be conducted at seven specific time points: baseline, 2 weeks after treatment, 4 weeks after treatment, and during follow-up at weeks 4, 8, 12, and 16. Outcomes include scores from the Visual Analog Scale (VAS) for pain, VAS for numbness, Neck Disability Index (NDI), Short Form-12 (SF-12) health survey, and monitoring of adverse reactions. Following the first treatment session and 4 weeks after treatment, Expectation Treatment Credibility Scale (ETCS) will be appraised. Furthermore, the study will record the overall cost incurred by each group after 4 weeks of treatment and the recurrence rates during the follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
This study did not implement blinding for the manipulative therapists and participants. However, blinding procedures were employed for the outcome assessors and data analysts, meaning that they remained unaware of the group.
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Conforming to the diagnostic criteria outlined in the 2010 North American Spine Society "An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders".
- •Aged between 40 and 65 years.
- •VAS score ≥ 4 points.
- •Duration of the condition ≤ 5 years.
- •Voluntary signature of informed consent form.
Exclusion Criteria
- •Combined with other types of cervical spondylosis.
- •Suspected or confirmed cases of cervical spine or intraspinal tumor, or intracranial tumor.
- •Patients with unclear diagnosis of spinal injury or symptoms of spinal cord injury.
- •Patients with developmental spinal canal stenosis (vertebral canal ratio = sagittal diameter of vertebral canal / sagittal diameter of vertebral body < 0.75).
- •Those suffering from severe heart, lung, brain, liver, kidney, or hematopoietic system diseases.
- •Conditions such as spinal tuberculosis, osteomyelitis, and osteoporosis.
- •Individuals who have undergone cervical spine surgery and those with cervical spine deformities.
- •Pregnant, planning to become pregnant, or breastfeeding women.
- •Participants unable to complete this clinical study due to mental illness, cognitive, or emotional disorders.
- •Those who have participated in other clinical studies in the past 3 months.
Arms & Interventions
The cervical traction group
The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks.
Intervention: Cervical traction (Other)
The high-frequency manipulation group
In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks.
Intervention: High-frequency rotation-traction manipulation (Other)
The low-frequency manipulation group
In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks.
Intervention: Low-frequency rotation-traction manipulation (Other)
Outcomes
Primary Outcomes
The Visual Analog Scale for Pain
Time Frame: 4 weeks
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Secondary Outcomes
- The Neck Disability Index(20 weeks)
- The Visual Analog Scale for Pain(20 weeks)
- The Visual Analog Scale for Numbness(20 weeks)
- The Short Form 12(20 weeks)
- The total cost(4 weeks)
- The recurrence rate(20 weeks)
- Expectation of Treatment and Credibility Scale(4 weeks)
- Adverse reactions(Up to 20 weeks)