Pragmatic controlled study to test the effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia

Jesús González-Lama, Paula Areso-Bóveda, Julia Mambrillas-Varela, Bárbara García-Gómez, José-Ignacio Moscosio-Cuevas, Eva Arnaiz-Rodríguez, María-Begoña Arroyo-Del-Barco, Pilar San-Teodoro-Blanco

Keywords: Central nervous system sensitization; chronic pain; fibromyalgia; neurosciences; pain measurement; patient education

Background:
Positive effects of pain neuroscience (PNE)-based methods in the management of chronic pain have been described. There are few data on the applicability of ENP in “real” clinical practice in primary care (PC).

Research questions:
Would a PNE-based intervention and exercise be feasible and effective in women with fibromyalgia (FM)?

Method:
Non-randomized pragmatic controlled trial conducted in PC health centers. Women in the intervention group (IG) were interviewed individually and then received 6 weekly sessions: those in the control group (CG) received their treatment-as-usual. The subject assignation to the groups was determined according to their availability to attend the sessions. They all filled in several questionnaires (prior to and 1 year after the intervention) to evaluate the impact of FM in their daily lives, catastrophism, anxiety and depression, severity and impact of pain in daily personal performance and functional capacity: Fibromyalgia Impact Questionnaire (FIQ) score was chosen as the primary outcome. The intergroup comparison of the changes in questionnaire scores were assessed by analysis of covariance with adjustments for baseline values and age. Effect sizes were evaluated using Cohen’s d.

Results:
53 women with FM were recruited, 35 in the IG and 18 in the CG. The reductions (improvements) in the scores of all tests (baseline-final) were greater in the IG (p<0.05), with moderate or high effect size. After one year, 20% (CI -1 to 42%) more women in the IG, compared to the CG, had a FIQ score <39 (mild functional impairment). 17/38 (49%) women in the IG no longer met FM criteria at the end of follow-up.

Conclusions:
An intervention based on PNE and exercise in patients with FM is feasible and seems effective in PC. However, the relatively small sample size and the absence of randomized group assignment limit the external validity of these promising results.

Points for discussion:
Do you think this type of intervention is suitable and feasible in your practice/city/country?

Would your "payer" (insurance companies/government) cover/support this type of intervention?

Based on other group activities you may have in your practice, how do you think this intervention could be improved to be more feasible/efficient?