Combined Physiotherapy and Cognitive Behavioral Therapy for Functional Movement Disorders: A Randomized Clinical Trial

Abstract

Importance: Functional movement disorders (FMDs) are frequent and disabling neurological disorders with a substantial socioeconomic impact. Few randomized studies have analyzed the effectiveness of combined physiotherapy and psychotherapy in patients' quality of life.

Objective: To assess the efficacy of multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy) in FMDs.

Design, setting, and participants: This was a parallel, rater-blinded, single-center, randomized clinical trial. Recruitment took place from June 2022 to April 2023, and follow-up visits were performed at months 3 and 5, concluding in October 2023. Participants were recruited from a national referral center for movement disorders: the Movement Disorders Unit from the Hospital Universitario Virgen Rocio in Seville, Spain. Patients had to be 18 years or older with a confirmed FMD diagnosis and capable of giving consent to participate. Patients who did not meet eligibility criteria or refused to participate were excluded. Any uncontrolled psychiatric disorder was considered an exclusion criterion.

Interventions: Patients were randomly assigned, in a ratio of 1:1 to multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy), or a control intervention (psychological support intervention).

Main outcomes and measures: Primary outcomes: between-group differences in changes from baseline to month 3 and month 5 in patients' quality of life (EQ-5D-5L score: EQ Index and EQ visual analog scale [EQ VAS]; and 36-Item Short-Form Survey Physical Component Summary [SF-36 PCS] and SF-36 Mental Component Summary [MCS]). Linear mixed models were applied, controlling by baseline severity and applying Bonferroni correction.

Results: Of 70 patients screened with an FMD, 40 were enrolled (mean [SD] age, 43.5 [12.8] years; age range, 18-66 years; 32 female [80%]; mean [SD] age at FMD onset, 38.4 [12.1] years), and 38 completed all the follow-up visits and were included in the analysis for primary outcomes. Multidisciplinary treatment improved SF-36 PCS with a mean between-group difference at 3 months of 4.23 points (95% CI, -0.9 to 9.4 points; P = .11) and a significant mean between-group difference at 5 months of 5.62 points (95% CI, 2.3-8.9 points; P < .001), after multiple-comparisons adjustment. There were no significant differences in other quality-of-life outcomes such as SF-36 MCS (mean between-group difference at 3 and 5 months: 0.72 points; 95% CI, -5.5 to 7.0 points; P = .82 and 0.69 points; 95% CI, 2.3-8.9 points; P = .83, respectively), EQ VAS (9.34 points; 95% CI, -0.6 to 19.3 points; P = .07 and 13.7 points; 95% CI, -1.7 to 29.0 points; P = .09, respectively) and EQ Index (0.001 point; 95% CI, -0.1 to 0.1 point; P = .98 and 0.08 points; 95% CI, 0-0.2 points; P = .13, respectively). At months 3 and 5, 42% and 47% of patients, respectively, in the multidisciplinary group reported improved health using the EQ-5D system, compared with 26% and 16% of patients, respectively, in the control group.

Conclusions and relevance: Results show that multidisciplinary treatment (physiotherapy plus cognitive behavioral therapy) effectively improves FMD symptoms and physical aspects of patients' quality of life. Further studies must be performed to evaluate the potential cost-effectiveness of this approach in FMD.

Trial registration: ClinicalTrials.gov Identifier: NCT05634486.

Figure 1.. Trial Profile

CBT indicates cognitive behavioral therapy.

Figure 2.. Primary Outcomes of Multidisciplinary Treatment for Functional Movement Disorders, as Compared With Control Intervention

A, Quantitative primary outcome domains in the intention-to-treat population. The primary outcomes (36-Item Short-Form Survey [SF-36] Physical Component Summary [PCS] and SF-36 Mental Component Summary [MCS]) are assessed through norm-based scoring to obtain a normalized value compared with the reference population, which exhibits a mean (SD) of 50 (10) points. Higher scores of PCS and MCS indicate better state of the quality of life domain. Scores of 50 (grid line) represent mean value in the reference population. EQ visual analog scale (EQ VAS) exhibits the patient’s self-perception of quality of health and is assessed on a scale from 0 to 100, with higher scores indicating better state of the quality of life. Values represent mean with 95% CI. B, Percentage of change from baseline to month 3 and month 5 in each domain of the continuous primary outcomes in both study groups. C, Changes in health for the intervention groups, according to the Paretian Classification of Health Change as measured by the EQ-5D (no change = the health profiles are the same; there has been no change in health as measured by the EQ-5D; improve = the second profile is better than the first; there has been an unequivocal improvement in health as measured by the EQ-5D; worsen = the second profile is worse than the first; there has been an unequivocal worsening in health as measured by the EQ-5D; mixed change = the first and second health profiles are noncomparable; there has been a change in health as measured by the EQ-5D but without further information we cannot say if it is an improvement or worsening). ^aP < .01.

Figure 3.. Secondary Outcomes of Multidisciplinary Treatment for Functional Movement Disorders, as Compared With Control Intervention

A, Secondary outcomes in the intention-to-treat population. The simplified Functional Movement Disorders (sFMDRS) ranges from 0 to 54, with higher scores indicating worse motor state of the FMD. Clinical Global Impression-Severity (CGI-S) ranges from 1 to 7, with higher scores indicating higher severity. Zarit Caregiver Burden Interview ranges from 22 to 110, with higher scores indicating higher level of caregiver burden by their relatives’ health problem. Values represent mean with 95% CI. B, Percentage of change from baseline to month 3 and month 5, in each domain of the continuous secondary outcomes in both study groups. C, Patient Global Impression of improvement at month 5 of both study groups.