Reference
Lee J, Cho JH, Kim KW, et al. Chuna manual therapy vs usual care for patients with nonspecific chronic neck pain: a randomized clinical trial. JAMA Netw Open. 2021;4(7):e2113757.
Study Objective
Researchers examined whether 5 weeks of Chuna therapy was more effective than usual care for patients with chronic neck pain.
Design
Designed as a 2-armed, multicenter, assessor-blinded, pragmatic randomized clinical trial, the study took place in South Korea between October 2017 and June 2019.
Investigators assessed more than 285 patients for participation, and of those, they accepted 108 into the study.
Participants
Individuals between the ages of 19 and 60 years were eligible for participation, including 286 individuals originally assessed with inclusion criteria such as duration of pain (more than 3 months), Numerical Rating Scale (NRS) for neck and upper limb pain scores, access to transportation, contraindicated medications, and history of surgery or traffic accident.
At its emergence, this study involved 108 patients (73 women and 35 men) with mean (SD) age of 38.4 years (9.3 years), duration of chronic neck pain for 48.6 months, and mean visual analog scale (VAS) score of 60.1. Patients with radiculopathy were accepted if their NRS pain score was the same for chronic neck pain as for radicular pain.
Participants were divided evenly into those who received Chuna manual therapy and those who received usual care (defined as physical or electrical therapy and oral medication). All 54 patients assigned to Chuna therapy completed the study, while 45 of 54 using the usual care protocols completed the study.
Investigators enrolled patients between October 18, 2017, and June 28, 2020, and their timelines included a 1-year follow-up after an initial 5-week course of treatment.
Intervention
Patients from both groups participated in 2 treatments per week for 5 consecutive weeks for a total of 10 treatment sessions.
This was a pragmatic clinical trial, so all practitioners used their clinical judgment and professional assessments to construct diagnoses and perform intervention therapies. Protocols for both Chuna and usual therapies were chosen from lists generated either by the 2014 Health Insurance Review and Assessment (HIRA) Service–National Patient Sample database for patients in the usual therapy group, or from a list of Chuna therapeutic techniques prepared by Chuna experts. These treatments overall included frequently prescribed drugs, exercises, physical therapy, or Chuna techniques and were used as a reference for providers to choose from when prescribing treatment. Limits were not imposed on the numbers or types of oral medications, physical treatments, or Chuna techniques within each session for either Chuna or usual therapy sessions.
Korean medicine doctors with a minimum of 3 years of Chuna experience performed the manual therapy techniques, receiving additional education and references from the Chuna Manual Medicine 2.5 edition, published by the Korean Society of Chuna Manual Therapy.
Up to 4 g per day of acetaminophen was permitted as a cointervention apart from treatment provided after randomization and through primary endpoint (5 weeks after randomization). Patients were not asked to restrict other interventions; after treatment concluded and during the observation period to end of study, only 4 patients in each treatment group chose to use acetaminophen.
Study Parameters Assessed
Investigators assessing the study parameters and outcomes were blinded to avoid revealing patient assignments. The following scales were used to assess patient responses before and after the study: VAS; NRS for neck and upper limb pain; Vernon and Mior Neck Disability Index (NDI) score; Northwick Park Neck Pain Questionnaire (NPQ); Patient Global Impression of Change (PGIC); and the European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L); Medical Outcomes Study 12-Item Short-Form General Survey (SF-12); and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SPH).
Primary Outcome Measures
The primary outcome measure was the VAS score for chronic neck pain at week 5.
Secondary outcomes included all other parameters assessed at week 5, as well as all outcomes at 1 year.
Key Findings
Overall, the Chuna therapy group reported significantly improved measures for all pain outcomes. At week 5, compared to usual care, there was a “difference in chronic neck pain VAS, 16.8 mm; 95% CI, 10.1-23.5 mm; NRS score, 1.6 points; 95% CI, 0.9-2.3 points; NPQ, 9.0%; 95% CI, 4.3%-13.7%; P < .001), function (difference in NDI, 8.6%; 95% CI, 4.2%-13.1%), and quality of life outcomes apart from the Mental Component Summary of the SF-12 (difference in the EQ-5D-5L scores, −0.07 points; 95% CI, −0.11 to −0.02 points; Physical Component Summary, −2.6 points; 95% CI, −4.9 to −0.3 points; Mental Component Summary, −0.8 points; 95% CI, −5.0 to 3.4 points).”
At 1-year assessment, many of the secondary outcomes remained improved for those in the Chuna group, including “chronic neck pain NRS (1.3 points; 95% CI, 0.5-2.0 points), NPQ (7.4%; 95% CI, 2.3%-12.6%), NDI (6.7%; 95% CI, 2.5%-10.9%), PGIC (−0.8 points; 95% CI, −1.3 to −0.4 points), WPAI-SPH scores (12.5%; 95% CI, 4.3%-20.8%), and EQ-5D-5L scores (−0.03 points; −0.07 to 0.00 points)."
Recovery was defined as a 50% or greater decrease in neck pain compared to baseline. Using both VAS and NRS scores for neck pain, all participants ranked Chuna therapy most effective at the end of week 1 and through week 5, as well as at the 1-year follow-up. The outcomes of physical examination between baseline and 5 weeks postrandomization indicate that patients treated in the Chuna therapy recorded a significant reduction in sensory disturbance; muscle weakness; and pain in flexion, extension, lateral flexion, and rotation, while some patients in the usual care therapy reported slight increases in sensory disturbance and muscle weakness and only moderate or no reduction in pain on flexion, extension, lateral flexion, and rotation.
The Chuna therapy group reported a total of 5 adverse events, including mild musculoskeletal and connective tissue disorders and 2 moderate nervous system disorders. The usual care group reported 3 incidents of moderate adverse events including 1 each in respiratory, musculoskeletal, and nervous systems.
Practice Implications
It is well-known in both Eastern and Western medicine that chronic neck pain can be due to myriad causes (eg, traffic accident, inflammation, congenital defects, work or sports injuries). According to the 2012 US National Health Statistics Reports, just over 14% of respondents (n=249,456) complained of neck pain or problems.1 Worldwide, lower back and neck pain led all causes of disability in 2015 and in many cases appear to have lifelong impacts on quality of life.2
Many studies have been conducted on treatments for neck pain, but few studies involving East Asian therapies outside of acupuncture have been published in mainstream journals. Publication of this study in the July 2021 JAMA online journal opens the door to many earlier studies and paves the way for future publications in other mainstream journals.
A lack of qualitative information regarding East Asian manual therapy approaches to chronic neck pain has been resolved with the publication of this pragmatic randomized clinical trial. With the publication, however, comes additional scrutiny.
As mentioned in the publication currently under review here, Chuna manual therapy is similar to Tuina manual therapy practiced in Traditional Chinese Medicine (TCM).
Both therapeutic practices employ Western and Eastern medicine approaches in assessing a patient’s condition, including biomechanical function and pathology, as well as diagnostics and theoretical understandings.
As in TCM, Chuna practitioners apply elements of mechanical function and meridian flow to construct a differential diagnosis and develop a treatment protocol. Manual therapeutic techniques include distraction and adjustment of the spine and joints, visceral manipulations, application of heat, soft tissue release, and other modalities. These techniques are taught within Korean Medicine (KM) colleges throughout South Korea.3
Worldwide, lower back and neck pain led all causes of disability in 2015 and in many cases appear to have life-long impact on quality of life.
In addition to its statistically significant findings for efficacy in treating chronic neck pain, the importance of this Chuna study to the complementary and alternative medicine (CAM) community in the United States is in legitimacy of applying individualized and pragmatic clinical judgments to select appropriate and successful manual therapies.
Conducted as a comparative analysis, the Chuna study under review highlights critical elements and significant implications of using East Asian (Korean) medical diagnosis and treatment in comparison to more standardized Western methods, dubbed “usual care” in this study.
This is not the first study of its kind. A 2018 study published in The Journal of Alternative and Complementary Medicine reported that a 3-week course of Tiuna treatment twice a week (for 6 treatments total) produced a clinically meaningful improvement in neck pain without serious adverse events.4
Not all reviews of manual therapy are positive. In 2015 the Cochrane Database of Systematic Reviews published an assessment regarding use of manipulation therapy compared to no treatment, sham treatments, or against another form of treatment. Results of this Cochrane Review suggest that treating chronic or subacute neck pain with cervical manual therapy was similar to other therapeutics and resulted in patient reports of improved quality of life and satisfaction measured with intermediate-term follow-up.5 While some reviews indicated adverse events after mobilization or manipulation, the Cochrane Review confirmed that these are rare occurrences.
One systematic review published in the journal Musculoskeletal Science and Practice in 2017 outlined adverse events of cervical spine manipulation or mobilization, but the majority of cases were found to be the result of inadequate preparation.6 In summarizing its 144 selected studies published prior to 2015, the authors of the 2017 study indicate that more detailed premanipulation testing and diagnosis would likely have prevented adverse events.
Previous studies highlighting similar CAM treatment options for chronic and subacute neck pain exist, but the designs and methodologies do not accommodate the personalized approach of practitioner decision-making when conducting an effective diagnosis and creating a patient’s treatment protocol. The current study under review is more pragmatic in that it includes this real-world clinical methodology. This randomized study demonstrating efficacy of Chuna over usual treatment paves the way for additional pragmatic studies for a variety of conditions.
Despite (or perhaps because of) its lack of attention in Western physical therapies, manual therapy and physical manipulation have been widely practiced in Korea since at least 1445 and the Joseon dynasty.7 This recent study helps to highlight the rich nature, evolution, and occasional complications of using aspects of traditional Korean medicine to perform treatment protocols for modern conditions, including treatment of chronic neck pain. The results of this research suggest that additional studies assessing the use of East Asian medical diagnosis and manual therapeutic treatment in pragmatic clinical trials are warranted.
