Addition of a new three-dimensional adjustable cervical thoracic orthosis to a multi-modal program in the treatment of nonspecific neck pain: study protocol for a randomised pilot trial

Ahmed S A Youssef, Nan Xia, Shimaa T E Emara, Ibrahim M Moustafa, Xiaolin Huang, Ahmed S A Youssef, Nan Xia, Shimaa T E Emara, Ibrahim M Moustafa, Xiaolin Huang

Abstract

Background: Nonspecific 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/design: This 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.

Discussion: This 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 registration: Prospectively registered at ClinicalTrials.gov, NCT03331120 . Registered on 22 October 2017.

Keywords: Ambulatory; Neck pain; Orthotic.

Conflict of interest statement

Ethics approval and consent to participate

This study follows the Declaration of Helsinki exactly. All participants will be completely informed of the study and will sign the informed consent before participation. This trial is approved by the Ethical Committee of Tongji Hospital (certificate of approval number TJ-IRB20170703).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interest(s).

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The flow diagram for this trial
Fig. 2
Fig. 2
Cervico thoracic posture corrective orthotic (CTPCO). a Anterior part of CTPCO. b Posterior part of CTPCO. Other images demonstrating the ability to move in different directions: a1 and a2 anterior and posterior translation; b1 and b2 lateral translation left and right; c1 and c2 side bending right and left; d1 and d2 rotation left and right; e1 extension; e2 flexion
Fig. 3
Fig. 3
Neck disability index (NDI). English and Chinese versions of the NDI
Fig. 4
Fig. 4
Global posture system (GPS). The GPS 600 device (Chinesport, Udine, Italy) consists of 1 software GPS 5.0, 2 desktop, 3 podostabil, 4 podata, 5 Lux postural analyzer
Fig. 5
Fig. 5
Examples of the photographs taken using the Global Posture System (GPS). a Anterior and posterior views. b Sagittal plane or lateral views. The six reflective markers used in the analysis are: acromion, anterior superior iliac spine, posterior superior iliac spine, glabella, tragus, C7 and middle sternal notch
Fig. 6
Fig. 6
Three-dimensional posture parameters measured by the GPS device. The postural parameters of the head in relation to the thoracic region: Postural translation A1 (Tz), A2 (Tx) measured in centimetres. Postural rotations B1 (RZ), B2 (Ry), B3 (Rx) measured in degrees

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