Context matters: the psychoneurobiological determinants of placebo, nocebo and context-related effects in physiotherapy.
Giacomo Rossettini, Eleonora Maria Camerone, Elisa Carlino...
https://pubmed.ncbi.nlm.nih.gov/32537245/Actively Recruiting
Led by Universidad Nacional de la Matanza · Updated on 2026-07-08
94
Participants Needed
2
Research Sites
13 weeks
Total Duration
Researchers are evaluating whether a Contextual Factors-Enriched Standard Care CFsSC approach can better reduce pain and improve function in adults with mechanical neck pain lasting more than 4 weeks. This assessor-blinded, randomized clinical trial will compare the CFsSC approach to Standard Care alone using validated tools like the Northwick Park Neck Pain Questionnaire and Numeric Pain Rating Scale. The study also explores effects on range of motion, global change perception, satisfaction, treatment credibility, and psychosocial factors. Participants will be randomly assigned to one of two groups receiving 4 weeks of treatment twice weekly. Both groups follow clinical guidelines including exercises, manual therapy, education, and a home care guide. The intervention group will have enhanced contextual factors such as positive professional attitudes, empathetic communication, and a supportive healthcare setting. Therapists receive specialized training, and treatment adherence is monitored through self-assessments and audits. Participants will attend scheduled sessions with reminders sent before each visit. Missed sessions may result in dropout and intention-to-treat analysis. Assessments occur at baseline, after 4 weeks of treatment, and at a 12-week follow-up. Outcomes measured include pain intensity, disability, range of motion, global rating of change, satisfaction, and treatment expectations. Data quality is ensured through monitoring and auditing, with the study conducted under ethical guidelines and regulatory standards.
CONDITIONS
Contextual Factors-Enriched Standard Care on Mechanical Neck Pain
M
Mauro F Andreu, PhD
F
Federico J Villalba, PT
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Universidad Nacional de la Matanza
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either standard care alone or standard care with enhanced contextual factors, including exercises, manual therapy, education, and a home care guide. Treatments are given twice weekly for 4 weeks.
Twice weekly visits (8 sessions total)
Duration - 8 weeks after treatment ends
Participants are reassessed to measure pain, disability, range of motion, and satisfaction at 12 weeks after treatment.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor