Efficacy and safety of Shi-style cervical manipulation therapy for treating acute and subacute neck pain: study protocol for a randomized controlled trial

Abstract

Background: Neck pain is a common clinical disease, which seriously affects people's mental health and quality of life and results in loss of social productivity. Improving neck pain's curative effect and reducing its recurrence rate are major medical problems. Shi's manipulation therapy has unique advantages and technical features that aid in the diagnosis and treatment of neck pain. Compared with first-line non-steroidal anti-inflammatory drug (NSAID) treatment of neck pain, Shi's cervical manipulation lacks the relevant research basis of therapeutic advantage, safety, and satisfaction for treating acute and subacute neck pain. Herein, we aim to confirm our hypothesis in a clinical trial that the safety and efficacy of Shi's cervical manipulation will be more effective, safer, and more satisfactory than NSAIDs to treat acute and subacute neck pain.

Methods: In this multicenter, positive-controlled, randomized clinical trial, traditional analgesic drug (NSAID) is used to evaluate and show that Shi's manipulation is more effective, safe, and satisfactory for treating acute and subacute neck pain. Overall, 240 subjects are randomly divided into the trial and control groups, with both groups treated by the corresponding main intervention method for up to 12 weeks. Clinical data will be collected before the intervention and immediately after the first treatment; at 3 days and 1, 2, 4, 8, and 12 weeks after the intervention; and at 26 and 52 weeks after treatment follow-up of clinical observation index data collection. The clinical observation indices are as follows: (1) cervical pain is the primary observation index, measured by Numerical Rating Scale. The secondary indices include the following: (2) cervical dysfunction index, measured by patient self-evaluation using cervical Neck Disability Index; (3) cervical activity measurement, measured by the cervical vertebra mobility measurement program of Android mobile phone system; (4) overall improvement, measured by patient self-evaluation with SF-36; and (5) satisfactory treatment, determined by patient self-evaluation.

Discussion: We will discuss whether Shi's cervical manipulation has greater advantages in efficacy, safety, and satisfaction of acute and subacute neck pain than traditional NSAIDs, to provide a scientific basis for the dissemination and application of Shi's cervical manipulation.

Trial registration: China Registered Clinical Trial Registration Center ChiCTR1900021371 . Registered on 17 February 2019.

Keywords: Acute neck pain; Diclofenac sodium sustained-release capsules; Effectiveness; Safety; Shi’s cervical manipulation; Subacute neck pain.

Fig. 1

Research flow chart

Fig. 2

Recommended content for the schedule of enrolment, interventions, and assessments. ^#If the subject has had the relevant imaging examination within 3 months and can provide the report form, no additional imaging examination is required. *If the subjects were directly enrolled at the first visit, visit 1 and visit 2 coincided in time, and visit 2 index was taken as the baseline