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Cervical Rotation-Traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: Study Protocol
Tianxiao Feng1, Xu Wang1, Kai Sun1,2
1Orthopedics and Traumatology Department, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, People's Republic of China.
Purpose:
Cervical radiculopathy (CR) poses a significant challenge due to its debilitating impact. Cervical rotation-traction manipulation (CRTM) is a representative manual therapy of traditional Chinese medicine (TCM) in China, which is beneficial to improve the pain, numbness, and dysfunction of CR patients. However, the optimal treatment frequency for CRTM remains systematically underexplored in randomized controlled trials (RCTs). This clinical study aims to assess the effectiveness and safety on three sessions per week of CRTM (TSWM) compared to one session per week of CRTM (OSWM) and cervical traction (CT) in patients with CR.
Patients And Methods:
This multicenter, three-arm, prospective RCT is conducted at four hospitals in China. Participants will be randomly allocated in a 1:1:1 ratio to one of the TSWM group, OSWM group, or CT group through the central randomization system. All participants will receive 4-week treatment and 16-week follow-up (total 20 weeks). The primary outcome is pain intensity of neck and arm measured by the Visual Analog Scale (VAS) at week 4. The secondary outcomes include VAS for pain intensity, VAS for numbness intensity, Neck Disability Index (NDI), Short Form 12 (SF-12), the total cost, the recurrence rate, and Expectation of Treatment and Credibility Scale (ETCS). Adverse events (AEs) will be monitored and reported throughout the trial.
Conclusion:
We expect this clinical study to evaluate the optimal frequency of CRTM for CR. It will also serve as a reference and exploration for investigating the dose-response relationship of manual therapy.
Trial Registration:
This clinical trial was registered at ClinicalTrials.gov (registration number: NCT06320249) on March 15, 2024.
