Clinical trial NCT06320249: Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy
Official title: Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Rotation-traction manipulation
Cervical radiculopathy
Treatment frequency
Dose effect
Randomized controlled trial
Lead sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Affiliated Hospital of Changchun University of Chinese Medicine
name: Dongzhimen Hospital, Beijing
First posted: 2024-03-20
Enrollment: 216
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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".
2. Aged between 40 and 65 years.
3. VAS score ≥ 4 points.
4. Duration of the condition ≤ 5 years.
5. Voluntary signature of informed consent form.

Exclusion Criteria:

1. Combined with other types of cervical spondylosis.
2. Suspected or confirmed cases of cervical spine or intraspinal tumor, or intracranial tumor.
3. Patients with unclear diagnosis of spinal injury or symptoms of spinal cord injury.
4. Patients with developmental spinal canal stenosis (vertebral canal ratio = sagittal diameter of vertebral canal / sagittal diameter of vertebral body \< 0.75).
5. Those suffering from severe heart, lung, brain, liver, kidney, or hematopoietic system diseases.
6. Conditions such as spinal tuberculosis, osteomyelitis, and osteoporosis.
7. Individuals who have undergone cervical spine surgery and those with cervical spine deformities.
8. Pregnant, planning to become pregnant, or breastfeeding women.
9. Participants unable to complete this clinical study due to mental illness, cognitive, or emotional disorders.
10. Those who have participated in other clinical studies in the past 3 months.

Primary outcomes:
measure: The Visual Analog Scale for Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: The Visual Analog Scale for Pain
timeFrame: 2 weeks
measure: The Visual Analog Scale for Pain
timeFrame: 8 weeks
measure: The Visual Analog Scale for Pain
timeFrame: 12 weeks
measure: The Visual Analog Scale for Pain
timeFrame: 16 weeks
measure: The Visual Analog Scale for Pain
timeFrame: 20 weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 2 weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 4 weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 8 weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 12 weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 16weeks
measure: The Visual Analog Scale for Numbness
timeFrame: 20 weeks
measure: The Neck Disability Index
timeFrame: 2 weeks
measure: The Neck Disability Index
timeFrame: 4 weeks
measure: The Neck Disability Index
timeFrame: 8 weeks
measure: The Neck Disability Index
timeFrame: 12 weeks
measure: The Neck Disability Index
timeFrame: 16 weeks
measure: The Neck Disability Index
timeFrame: 20 weeks
measure: The Short Form 12
timeFrame: 2 weeks
measure: The Short Form 12
timeFrame: 4 weeks
measure: The Short Form 12
timeFrame: 8 weeks
measure: The Short Form 12
timeFrame: 12 weeks
measure: The Short Form 12
timeFrame: 16 weeks
measure: The Short Form 12
timeFrame: 20 weeks
measure: The total cost
timeFrame: 4 weeks
measure: The recurrence rate
timeFrame: 20 weeks
measure: Expectation of Treatment and Credibility Scale
timeFrame: 1 day
measure: Expectation of Treatment and Credibility Scale
timeFrame: 4 weeks
measure: Adverse reactions
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wangjing Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References:
citation: Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.