Background & Aims
Pain and physical function are recommended as two important outcome measures two be considered in clinical trials of chronic pain (Dworkin et al., 2005, Langford et al., 2022). However, many trials fail to show significant or clinically important changes in these outcomes, leading to a discussion of how relevant they are. Several pharmacological studies have used a minimum entry level criteria for pain intensity, however this have infrequently been implemented in trials of psychological treatments. In this study we aim to report baseline levels of pain in a large sample of participants from a multicenter randomized controlled trial of Acceptance and commitment therapy (Hayes et al., 2011) in Norway.
Methods
This study is a large multicenter RCT based on a collaboration between the multidisciplinary pain clinics at the university hospitals in Oslo, Tromsø, Bergen and Trondheim. Patients were recruited between august 2020 and January 2023 and randomized to one of three conditions: ACT, ACT with enhanced mindfulness and patient education. Each condition was as given as group treatment in 8 sessions of four hours each. Patients were included if they had a primary diagnosis of chronic pain. Exclusion criteria were severe somatic disease, severe mental disorder, not being able to communicate in Norwegian, or waiting for or receiving other forms of treatments such as surgery, rehabilitation or psychotherapy in the specialist health care. Primary and secondary outcome measures were the Brief Pain Inventory pain intensity and interference scales.
Results
A total of 502 participants agreed to participate in the study and attained at least 4 out of 8 group sessions. The majority were female (n=383, 76.3%), and had a mean age of 46.2 years (SD 12.0). The mean pain intensity score was 5.46 (SD 1.5). When categorized into pain intensity levels, 15.9% reported mild (0-3.99), 66.1% moderate (4-6.99) and 18.0% (>7) severe pain intensity. The mean pain interference score was 5.4 (SD 1.8). When categorized into pain interference levels, 20.6% reported mild (0-3.99), 57.7% reported moderate (4-6.99) and 21.7% (>7) reported severe interference with functioning. When the scale was divided into physical and mental interference, mean scores were 5.4 (SD 2.0) for physical and 5.3 (SD 2.2) for mental interference.
Conclusions
The majority of participants reported moderate to severe pain intensity and interference. For these participants, a reduction in these outcomes may be considered relevant. However, a notable proportion of participants reported mild or minimal pain intensity and interference at baseline. For these participants, a reduction in these outcomes may be considered less realistic and desirable. Further evaluations of the use of minimum baseline pain intensity in clinical trials of psychological interventions are needed.
References
Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., … & Witter, J. (2005). Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain, 113(1-2), 9-19.
Langford, D. J., Baron, R., Edwards, R. R., Gewandter, J. S., Gilron, I., Griffin, R., … & Dworkin, R. H. (2022). What should be the entry pain intensity criteria for chronic pain clinical trials? An IMMPACT update. Pain, 10-1097.
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and commitment therapy: The process and practice of mindful change. Guilford press.
Presenting Author
Mari Glette
Poster Authors
Topics
- Treatment/Management: Pharmacology: Psychological and Rehabilitative Therapies