Background & Aims
The literature has described a great influence of pain/movement-related fear and catastrophic thoughts related to pain on the intensity of pain and disability in patients with chronic pain [1-9]. To the best of our knowledge, there is no evidence of graded exposure-based therapy on patients with chronic shoulder pain in terms of efficacy and cost-effectiveness. The aim of this feasibility trial is to assess: (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) adherence to the treatments; (4) drop-out rates; (5) preliminary estimates of adverse events; (6) costs related to shoulder pain management.
Methods
This study is a two-arm, assessor-blinded, feasibility randomized controlled trial with ten participants in each group. Participants were recruited from September 2022 to June 2023. The intervention protocol followed a patient-centered approach. The control group (CG) received global shoulder strengthening exercises and manual therapy, with sessions applied twice a week for eight weeks. In the graded exposure group (GEG), the physiotherapist evaluated fear of movement-related pain and avoidance behaviors using the ADAP Shoulder Scale. The main goal of exposure therapy was to violate the individual’s threat expectations about moving their shoulder. Techniques for cognitive reassurance and self-efficacy were also applied to the GEG. The GEG treatment frequency was pragmatic for each patient, carried out twice a week and varying from a minimum of four to a maximum of 16 sessions based on the patient’s clinical improvement.
Results
Thirty patients were evaluated. Five were excluded due to being diagnosed with fibromyalgia, three due to pain of traumatic origin, one post-surgical, and one due to pain of cervical origin. Twenty patients were randomized into two groups. The CG showed a median adherence to treatment of 13 sessions, and the GEG had an median of 8 sessions, with six patients receiving only eight sessions due to finishing the exposure hierarchy. The drop-out rates were high in the control group, with a sample loss of 40% before the end of the fourth week and 10% before the end of the treatment, primarily related to work issues and traumatic events at home during the course of the treatment. No losses were reported for the GEG. For costs related to the interventions, healthcare, patients, and loss of productivity at 6 weeks before the evaluation, we found a total expenditure of US$59.00 per patient in the GEG a and US$108.14 per patient in the CG. No adverse events were reported during the study.
Conclusions
The intervention on the exposure group showed to be trial feasible, safe, and presented higher adherence compared to the control group. The control group received personalized treatment focused on muscle group load and adjustment, whereas the exposure group’s targeted feared daily activities, functional limitations, and patient beliefs. This approach appears meaningful for patients and contributes to treatment adherence. Notably, the control group had higher costs due to shoulder pain. It is crucial to underscore that the disease’s costs are likely to increase, driven by factors such as absenteeism, medication expenses, and the new shoulder pain treatments. This holds particular significance considering that the patients originate from a middle-income country grappling with high unemployment and poverty rates, relying exclusively on the public health system. Collecting cost data has feasible, offering insights into the economic implications of implementing the intervention.
References
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Presenting Author
Marcela Camargo Tozzo
Poster Authors
Gisele Harumi Hotta; Phd
PhD
Universidade Cidade São Paulo (UNICID), São Paulo – SP
Lead Author
Rafael Alaiti
Universidade de São Paulo
Lead Author
Felipe Reis
Federal Institute of Rio De Janeiro
Lead Author
Marcela Tozzo
Sao Paulo University
Lead Author
Vinícius Sacioti
University of São Paulo
Lead Author
Leticia Jonas de Freitas
MSc
University of São Paulo, Ribeirão Preto, São Paulo/Brazil
Lead Author
Anamaria Siriani de Oliveira
Universidade de São Paulo
Lead Author
Topics
- Treatment/Management: Interventional Therapies – Other