Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy

Wangjing Hospital, China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Cervical Radiculopathy

Treatments: Other: Low-frequency rotation-traction manipulation; Other: High-frequency rotation-traction manipulation; Other: Cervical traction

Study type: Interventional

Funder types: Other

Identifiers

NCT06320249

WJYY-XZKT-2023-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 3 patient groups

The high-frequency manipulation group

Experimental group

Description:

In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks.

Treatment:

Other: High-frequency rotation-traction manipulation

The low-frequency manipulation group

Experimental group

Description:

In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks.

Treatment:

Other: Low-frequency rotation-traction manipulation

The cervical traction group

Active Comparator group

Description:

The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks.

Treatment:

Other: Cervical traction