Pilot Trial Will Test Houxi Acupuncture for Acute Stiff Neck Pain
Acute neck pain caused by a stiff neck is common, abrupt, and often disabling enough to interfere with turning the head, working, or sleeping. In this BMJ Open protocol, investigators plan to examine whether acupuncture at the Houxi (SI3) acupoint can improve symptoms beyond local massage in patients with acute neck pain from stiff neck. The study is framed as a feasibility trial as much as an efficacy study, which is the right place to begin when a treatment is widely used but still lacks reliable trial data.
The protocol is modest in size and deliberately focused. Thirty-six participants with stiff neck and acute neck pain will be enrolled and assigned in a 1:1 ratio to either acupuncture plus massage or massage alone. The control condition consists of local neck massage for 5 minutes per session, three times a day for 3 days. The treatment arm adds one acupuncture session per day for 3 days. Outcomes will be measured at baseline, day 3, and day 15, creating a short but clinically relevant window that captures both immediate symptom relief and whether early benefit persists after treatment ends.
Why Houxi (SI3) Was Chosen for Neck Pain
Houxi, or SI3, is a traditional acupuncture point often linked in Chinese medicine practice with disorders of the neck and upper back. The biologic logic proposed for acupuncture in this setting is plausible even if still incompletely proven: stimulation at a peripheral point may alter pain signaling, reduce muscle spasm, and influence local and central nociceptive processing. In a stiff neck, pain and restricted movement can reinforce each other through guarding of the cervical musculature. A therapy that interrupts that cycle could improve function as well as pain intensity.
The comparison with massage is clinically sensible because massage is an active intervention rather than a sham procedure. Patients with acute neck stiffness often improve with time, warmth, touch, and muscle relaxation, so the trial asks a practical question: does acupuncture at SI3 add benefit on top of a basic conservative approach already used in everyday care? In that sense, the study is designed to reflect real-world decision-making rather than an artificial laboratory setting.
One sentence captures the core uncertainty: the trial is asking whether a single acupoint can do more than a short course of local manual therapy.
Outcomes Centered on Function and Pain Intensity
The primary endpoint is the Northwick Park Neck Pain Questionnaire (NPQ), a functional measure that tracks how neck pain affects daily activity. Choosing a disability-oriented endpoint is important because acute neck pain is not just a sensory complaint; it disrupts motion, sleep, driving, and routine work. Pain scores alone can miss whether a patient can actually move more freely or perform ordinary tasks without guarding.
The secondary endpoint is the Short Form of the McGill Pain Questionnaire (SF-MPQ), which provides a structured assessment of pain quality and intensity. Used together, the two instruments should give a more complete picture of whether acupuncture changes both the subjective burden of pain and the practical consequences of neck stiffness. The brief follow-up schedule also helps determine whether any early response fades quickly or holds through day 15, a point that matters when the condition itself may resolve spontaneously.
Because this is a pilot study, the emphasis is not on proving a definitive treatment effect. The more immediate objective is to learn whether the design is workable: whether participants can be recruited, whether randomization and blinding procedures can be maintained at the assessor level, and whether the outcome measures are sensitive enough to detect change over a short treatment course. Those are essential questions before a larger efficacy trial can be justified.
Assessor Blinding and a Small, Practical Design
The trial is structured as a two-parallel-group, assessor-blinded, randomized controlled study. Assessor blinding is especially important in a hands-on intervention trial because participant expectations can be powerful when needles and manual therapy are involved. If the person scoring outcomes remains masked to treatment assignment, the risk of measurement bias falls, even if complete participant blinding is not feasible.
The sample size of 36 is small, but that is appropriate for a pilot study intended to test feasibility. A limited cohort can still reveal whether the protocol is operationally sound and whether the direction of change justifies expansion. Acute neck pain also has a relatively short clinical course, which makes it suitable for a tightly timed intervention and follow-up schedule. The investigators will be able to observe early symptom change without requiring prolonged treatment or an extended observation period.
Safety is not a trivial concern in any acupuncture trial, even when the intervention is routine in traditional practice. Needling at any point requires proper technique and attention to adverse events, especially in a region where muscles, vessels, and nerves are closely packed. The protocol itself does not describe a detailed safety signal because this is a design paper, not a results paper, but any future efficacy trial will need to document tolerability with the same rigor applied to symptom outcomes.
Ethics Approval and What This Protocol Can Actually Deliver
The protocol has undergone ethics review and received approval from the ethics review board of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine. The trial is registered under ChiCTR-TRC-13003911. Registration and ethics approval give the project a formal clinical framework and allow the study to contribute evidence that can be evaluated against the published protocol.
What this study can deliver is narrower, but still useful. It can show whether acupuncture at Houxi is practical for patients with acute stiff-neck pain, whether short-term improvements appear greater than massage alone, and whether the chosen instruments capture meaningful change over 3 and 15 days. If the trial performs well, it may justify a larger controlled study with enough power to assess clinical effectiveness more convincingly.
What it cannot do is settle the question by itself. A 36-patient pilot cannot establish definitive efficacy, and the protocol does not claim otherwise. Still, for a treatment that has long been used but not adequately tested in this exact setting, a well-conducted pilot is a necessary first step. The value lies in disciplined trial architecture: a defined acupoint, a clear comparator, functional and pain-based endpoints, and a short timeline that mirrors the pace of acute neck pain in practice.