Shallow Acupuncture for Chronic Neck Pain: A Multicenter Randomized Controlled Trial Protocol with fMRI and DTI

Chronic neck pain represents one of the most challenging health problems today, affecting approximately one in four adults globally. This condition, characterized by persistent pain in the neck and shoulder region for more than three months, not only significantly compromises patients' quality of life but also generates substantial costs for healthcare systems. Conventional treatment frequently relies on nonsteroidal anti-inflammatory medications, such as celecoxib, which, although effective for pain relief, can cause gastrointestinal and cardiovascular side effects when used for prolonged periods. In this context, shallow acupuncture emerges as a promising therapeutic alternative, offering a less invasive approach with lower risk of adverse effects.

This pioneering study proposes to investigate the brain mechanisms of shallow acupuncture in the treatment of chronic neck pain through a multicenter randomized controlled clinical trial. The main objective is to understand how this specific acupuncture technique modifies brain activity and structure in patients with chronic neck pain, using advanced neuroimaging technologies. The research will be conducted at three medical centers in China, involving 252 patients divided equally among three groups: shallow acupuncture, drug control with celecoxib, and waiting list. Additionally, twenty healthy volunteers will participate as a control group for the neuroimaging analyses.

The study methodology employs functional magnetic resonance imaging and diffusion tensor imaging to map brain changes before and after treatment. Shallow acupuncture differs from traditional acupuncture by using pathological reactive points on the skin surface, inserting needles at minimal depth and focusing on the superficial layers of tissue. The treatment points are identified through specific skin alterations, such as changes in coloration, tension, pore distribution, and abnormal sensitivity. The treatment protocol consists of six sessions over two weeks, with needles remaining inserted for fifteen minutes in each session.

The results of this research promise to reveal important findings about how shallow acupuncture modifies brain circuits related to chronic pain. Previous studies have demonstrated that patients with chronic neck pain present specific functional and structural alterations in the brain, including changes in connectivity between regions such as the thalamus, insular cortex, and somatosensory areas. Traditional acupuncture has already shown the ability to normalize some of these alterations, but the specific mechanisms of shallow acupuncture remain unexplored. The findings are expected to demonstrate how this technique influences pain signal transmission through the spinothalamic tract and modifies activity in brain regions responsible for pain processing and modulation.

The clinical implications of this study are substantial for both patients and healthcare professionals. For patients, the results may scientifically validate a less invasive therapeutic option with lower risk of side effects compared with conventional medications. Shallow acupuncture, if it proves to be of equivalent or superior efficacy to celecoxib, offers a particularly valuable alternative for patients who cannot use anti-inflammatory drugs due to medical contraindications or who prefer to avoid medications. For practitioners, the study provides neurobiological evidence that may guide more informed therapeutic decisions and potentially expand the use of shallow acupuncture for other chronic pain conditions.

The study presents some important limitations that should be considered in the interpretation of results. The neuroimaging sample size, although adequate according to literature recommendations, is relatively small, which may limit the generalizability of the findings. The three-month follow-up period, although sufficient to assess short-term effects, does not allow conclusions about the durability of long-term benefits. Additionally, the nature of the acupuncture intervention makes complete blinding of participants impossible, although the researchers have implemented strategies to minimize biases through independent assessors and blinded statistical analysis.

This research represents a significant advance in the scientific understanding of shallow acupuncture, being the first study to combine functional magnetic resonance imaging and diffusion tensor imaging to investigate its mechanisms of action in chronic neck pain. The results will contribute to the development of more effective treatment protocols and may pave the way for broader applications of shallow acupuncture in other neurological conditions. Regardless of the specific results, this study sets an important methodological precedent for future research in integrative medicine, demonstrating how modern neuroimaging techniques can be used to validate and understand traditional therapies, favoring a more personalized and evidence-based approach to chronic pain treatment.