Neck type cervical spondylosis (NTCS) is the most common subtype (60–70% of cases), with neck pain affecting 20–50% of adults annually and up to half progressing to chronic symptoms. TCM external therapies (e.g., herbal plasters, topical ointments, fumigation, medicated moxibustion, acupoint application) are widely used, yet the evidence base is limited by methodological flaws. A COMET database search (May 2026) identified three ongoing cervical spondylosis COS projects – addressing acupotomy (Project 3344), postoperative axial symptoms (Project 3304), and vertebral artery type (Project 1706). These are clinically and interventionally distinct from our scope: our COS specifically targets NTCS and focuses exclusively on non invasive topical external therapies, explicitly excluding acupotomy to avoid overlap. No existing or ongoing COS addresses this specific population and intervention, representing a critical gap. Systematic reviews of RCTs reveal >80 heterogeneous outcomes without primary/secondary distinction, over reliance on surrogate endpoints over patient important outcomes (pain, function, quality of life, recurrence), lack of validated instruments, and inconsistent measurement time points – all impeding data synthesis. This will be the first NTCS specific COS for TCM external therapies, featuring integration of TCM pattern differentiation outcomes (e.g., cold aggravated pain), multi stakeholder Delphi consensus (clinicians, researchers, patients), and alignment with OMERACT Filter 2.0 and COS STAR. Methods include: (1) systematic review of outcome heterogeneity in RCTs; (2) semi structured patient interviews ; (3) two round Delphi survey (consensus: =70% rating 7–9 and =15% rating 1–3 on a 9 point Likert scale); and (4) a consensus meeting. The COS will establish a minimum standardised outcome set for future trials, enabling comparability, meta analysis, and high certainty evidence for clinical practice and policy.
Contributors1.Tian Wang (Resident Doctor), Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China.
2. Jinyu LI (Professor/ Chief physician), Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China.
Disease Category: Orthopaedics & trauma
Disease Name: cervical spondylosis, Neck type cervical spondylosis
Age Range: 18 - 70
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
(1) Systematic review of outcome heterogeneity in RCTs; (2) semi-structured patient interviews ; (3) two-round Delphi survey (consensus: =70% rating 7-9 and =15% rating 1-3 on 9-point Likert scale); (4) consensus meeting.
Following COMET methodology, this study will be divided into three processes. The first step is to systematically review the clinical studies of axial symptoms, screen these clinical research literatures, extract the result index data, form a preliminary result index set, and publish scoring review as well as systematic review and network meta-analysis. The second step is to conduct Delphi survey on experts and patients to further evaluate the importance of each outcome indicator. The third step is to hold an expert consensus meeting and invite well-known experts in this research field to discuss and reach a consensus on the clinical core outcome indicators of axial symptoms.