Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial

• Published in: Current controlled trials in cardiovascular medicine 2024-07, Vol.25 (1), p.442-9, Article 442
• Main Authors: Barbosa da Silva, Aron Charles, Santana, Gabriela Nascimento, Santos, Inaê Silva, Dos Santos, Patrícia Gabrielle, de Oliveira, Adriano Rodrigues, Filho, Almir Vieria Dibai, de Paula Gomes, Cid André Fidelis
• Format: Article
• Language: English
• Subjects: Adult; Chronic Pain - diagnosis; Chronic Pain - physiopathology; Chronic Pain - therapy; Clinical trials; Combined Modality Therapy; Disability; Disability Evaluation; Evidence-based medicine; Exercise therapy; Exercise Therapy - methods; Female; Health aspects; Humans; Intervention; Low-level light therapy; Low-Level Light Therapy - methods; Male; Manipulative therapy; Middle Aged; Neck pain; Neck Pain - diagnosis; Neck Pain - physiopathology; Neck Pain - therapy; Pain Measurement; Phototherapy; Physical fitness; Quality of Life; Randomized Controlled Trials as Topic; Rehabilitation; Software; Study Protocol; Time Factors; Treatment Outcome; Tumors
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08289-1

Neck pain is a prevalent global musculoskeletal issue, significantly contributing to the loss of years of healthy life due to disability. Chronic nonspecific neck pain (CNNP) involves diverse symptoms impacting mobility and quality of life. While therapeutic exercises demonstrate efficacy, the role of photobiomodulation therapy (PBMT) remains uncertain. This study aims to assess the additional effects of PBMT within a multimodal therapeutic intervention for CNNP. A randomized, two-arm, controlled, blind clinical trial follows CONSORT and SPIRIT guidelines. Participants diagnosed with CNNP will receive a stand-alone multimodal therapeutic intervention or the same program with additional PBMT. The primary outcomes will be assessed by the functional disability identified through applying the NDI (Neck Disability Index). Secondary outcomes will be pain intensity during rest and active neck movement, catastrophizing and kinesiophobia, functionality, and disability assessed at baseline, after 8 weeks, and at a 4-week follow-up. Both groups receive pain education before personalized interventions, including resistance exercises, neuromuscular activities, mobility, and body balance. The PBMT group undergoes low-level light therapy. Intention-to-treat analysis, using linear mixed models, employs data presented as mean, standard deviation, and differences with a 95% confidence interval. Non-normally distributed variables transform. Statistical significance is set at 5%. This study addresses a critical gap in understanding the combined effects of PBMT and therapeutic exercises for CNNP. The findings aim to guide clinicians, researchers, and CNNP sufferers through rigorous methodology and diverse outcome assessments, offering valuable insights into evidence-based practices for CNNP management. Data confidentiality is maintained throughout, ensuring participant privacy during statistical analysis. Effects of adding photobiomodulation to a specific therapeutic exercise program for the treatment of individuals with chronic nonspecific neck pain, registration number: NCT05400473, on 2022-05-27.