A Comparative Study of a Novel Postural Garment Versus Exercise for Women with Nonspecific Cervical Pain: A Randomized Cross-over Trial.

STUDY DESIGN: Randomized cross-over study. OBJECTIVE: The aim of this study was to compare exercise, the criterion standard, to the postural garment PosturePlusForce in the management of nonspecific cervical pain in women. We also analyzed both interventions with regards to baseline posture, use of pharmacological pain relievers, compliance, and comfort. SUMMARY OF BACKGROUND DATA: The prevalence of neck pain has increased during the last decade, preferentially affecting women. Those suffering from this condition may manifest a decrease in quality of life and inability to work. Consistent recommendations highlight the importance of exercise and posture for neck pain improvement. METHODS: A total of 32 female health care professionals with cervical pain (≥3 on the visual analogue scale) entered the trial. Participants were allocated to either performing exercises or wearing the postural garment. The cross-over between interventions was separated by a 3-month washout period. Primary outcomes included pain intensity and posture. Secondary outcomes comprised cervical pain-related disability, psychological factors, physical activity, global perceived effect of treatment, and garment comfort. Treatment compliance, medication use, and adverse events were also recorded. RESULTS: Both interventions showed a significant improvement in pain in subjects with an adherence >60%. However, in participants with dorsal hyperkyphosis (>45°), the garment demonstrated a greater reduction in pain than exercise (P = 0.019). Additionally, those wearing the garment needed fewer pain relievers than those performing exercises (P = 0.007). Compliance was >50% for both interventions and comfort was contingent on season. CONCLUSION: In our study, PosturePlusForce showed, at least, a similar effect on pain to exercise, although those with dorsal hyperkyphosis exhibited a greater reduction in pain and related variables with the garment. Pain relievers were less required by those wearing PosturePlusForce than by those performing the exercises.Level of Evidence: 1.

Comparative Study of Postural Garment Versus Exercises for Patients With Nonspecific Cervical Pain: Protocol for a Randomized Crossover Trial.

BACKGROUND: There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise. OBJECTIVE: This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders. METHODS: This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models. RESULTS: The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020. CONCLUSIONS: The Postural garment is expected to improve cervical pain by enhancing posture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14807.