Active behavioural physiotherapy intervention for acute non-specific neck pain: a cluster randomised double-blind pilot and feasibility clinical trial

Abstract

Purpose

To evaluate the feasibility of an active behavioural physiotherapy intervention (ABPI) and procedures to prevent the transition to chronicity in patients with acute non-specific neck pain (ANSNP).

Materials and methods

A cluster-randomised double-blind (assessors and participants), parallel 2-arm (ABPI versus standard physiotherapy intervention [SPI]) pilot and feasibility clinical trial was conducted owing to a pre-specified published protocol. Six public hospitals were recruited and cluster-randomised (computer-generated randomisation with block sampling). Sixty participants (30 in each arm, 10 per hospital) were assessed at baseline and 3 months following baseline for neck disability index, numerical pain rating scale, cervical range-of-motion, fear-avoidance beliefs questionnaire and EuroQol 5-dimension 5-level.

Results

All procedures worked well. The participants’ median age was 36.5 (range 21–59, interquartile range: 20.75) years. Participants in the ABPI demonstrated better improvement in all outcomes compared to SPI. Furthermore, the number of fully recovered participants following ABPI (27/30, 90.00%) was higher than SPI (16/30, 53.33%) with fewer treatment sessions and lower costs of management.

Conclusions

The findings suggest that the ABPI is feasible and valuable (e.g. a high number of fully recovered participants, fewer treatment sessions and reduced management costs compared to the SPI) in conducting a future definitive trial to evaluate the effectiveness of the ANSNP management.

Trial registration

TCTR20180607001

IMPLICATIONS FOR REHABILITATION

• An active behavioural physiotherapy intervention (ABPI) is feasible to manage acute non-specific neck pain.

• The ABPI demonstrated a high number of fully recovered participants, fewer treatment sessions and reduced management costs compared to the standard physiotherapy intervention.

• The ABPI is valuable to conduct a future definitive trial to evaluate the effectiveness of acute non-specific neck pain management.

Keywords:

• Neck pain
• pilot study
• feasibility study
• clinical trial
• active behavioural physiotherapy intervention

Acknowledgement

Authors would like to thank participating hospitals; Lampang Hospital (Tawatchai Luedsri and Samaphron Weingchan), Chumphae Hospital (Junjira Piyatatsri and Panadda Thanutith), Wichianburi Hospital (Kotchakorn Kesamoon and Chorpikul Chidsanit), Sukhothai Hospital (Chaves Khatkhanwong and Pronphan Prompriang), Watbot Hospital (Arin Saengprateeptong and Wasinee Sonsri) and Huayploo Hospital (Anusara Sangploy and Phaopan Phothongnak) including their staff.

Ethical statement

The trial was conducted in accordance with the Declaration of Helsinki and the ethical guidelines for medical human research and was approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).

Author contributions

TW was the chief investigator and guarantor leading to the drafting of the initial manuscript, manuscript development, analyses and dissemination. TW, SU and AR contributed to clinical and methodological decisions to ensure the trial quality. TW and WC contributed to data collection. TW, SU, WC and AR contributed data interpretation, conclusions and dissemination. All authors read and agreed on the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Data sharing will be provided based on legal and ethical possible. The data will be made available upon reasonable request.

Additional information

Funding

The trial was funded by the Thailand Research Fund (grant number: MRG6180069).