NCT06320249

Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy

Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Radiculopathy

Interventions

Type	Name	Description
OTHER	High-frequency rotation-traction manipulation	The procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks.
OTHER	Low-frequency rotation-traction manipulation	The procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks.
OTHER	Cervical traction	The procedure for cervical traction is as follows: The patient assumes a sitting position, and a cervical traction device with a chin strap is applied. The patient is instructed to slightly flex their head forward, approximately 10-15 degrees, based on their comfort level and symptom relief. Traction force starts at 3 kg and increases gradually in increments of 0.5 kg, with a maximum weight not exceeding 6 kg. The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: China