Abstract
BackgroundNonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists. Posture has emerged as one of the major risk factors associated with NSNP, but most previous studies ignored correct posturing as an effective treatment. Therefore, one of the major challenges faced by clinicians is how to incorporate 3D posture findings into the treatment plane. The present study will evaluate the feasibility of conducting a larger randomized trial. This pilot study is designed to investigate the hypothesis that a multimodal programme supplemented with the addition of a 3D adjustable cervico thoracic posture corrective orthotic (CTPCO) will yield short- and long-term improvement on NSNP management outcomes.Methods/designThis pilot, single-blind, randomized controlled trial will divide 24 patients into two groups (study and control) using block randomization. Both groups will receive conventional treatment consisting of a moist hot pack, soft tissue mobilization, manual therapy and therapeutic exercise. The study group will undergo ambulatory mirror-image functional re-training wearing a 3D adjustable CTPCO. The primary outcome is feasibility, including recruitment (e.g., time to complete enrolment, recruitment rate), patient retention and adherence to treatment allocation (e.g., session attendance, home practice, use of non-study treatments). The secondary outcomes used to assess the effectiveness of the treatment will include neck pain (measures using the visual analogue scale (VAS)) and neck disability (measures using the neck disability index (NDI)), among other outcome measures, compared between the experimental and control groups. Three-dimensional posture parameters of head measurements will be provided by a Global Posture System (GPS). The outcome measures for determining the treatment effect will be assessed at three intervals: pre-treatment, after 10 weeks of intervention and after 3 months at follow-up.DiscussionThis randomized controlled pilot trial will inform the design of a future full-scale trial. The outcomes will provide some resources for the incorporation of ambulatory mirror-image functional re-training intervention compared to a control group intervention for neck pain, disability and 3D posture parameters.Trial registrationProspectively registered at ClinicalTrials.gov, NCT03331120. Registered on 22 October 2017.
Highlights
Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists
The outcomes will provide some resources for the incorporation of ambulatory mirror-image functional re-training intervention compared to a control group intervention for neck pain, disability and 3D posture parameters
The primary aim of this study is to evaluate the feasibility of conducting a larger randomized trial that considers recruitment, compliance to study protocols and adverse events
Summary
NSNP is one of the four most frequently reported musculoskeletal problems [40]. It is predictable in the adult ‘world population’, which exhibits a mean lifetime incidence of 48%, annual incidence of 38 to 73%, monthly incidence of 25%, one week prevalence ranging from 8 to 45%, and point incidence of 10% [4]. The second reason to expect more effective changes is because the treatment programme in this study will concentrate on rehabilitation of the spine in a reflexive environment This interpretation agrees with Christensen, who reported the important role of rehabilitation in a reflexive environment, especially for posture correction exercises because posture is highly controlled by reflex activity [42]. The results of this study are expected to provide information on the feasibility of conducting RCT evaluations of the effect of the addition of a new, 3D adjustable CTPCO to multimodal treatment of NSNP and evaluations of the use of ambulatory mirror-image functional re-training via the wearing of a CTPCO as one of the multimodal exercises used for correcting posture in 3D directions in NSNP patients. Abbreviations 3D: Three-dimensional; ASIS: Anterior superior iliac spine; CONSORT: Consolidated Standards of Reporting Trials; CTPCO: Cervico thoracic posture corrective orthosis; GPS: Global Postural System; HUST: Huazhong University of Science and Technology; NDI: Neck disability index; NSNP: Nonspecific neck pain; PSIS: Posterior superior iliac spine; RCT: Randomised control trial; VAS: Visual analogue scale
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