Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: a randomized clinical trial

Objectives: To evaluate the effectiveness of an energy conservation management (ECM) intervention versus an MS-nurse control intervention for treating fatigue in persons with multiple sclerosis (MS). Design: Single-blind, two-parallel-arms randomized clinical trial (RCT). Setting: Two outpatient rehabilitation departments. Subjects: Adult persons with definite MS, severe fatigued, and being ambulatory. Interventions: The individual-based ECM intervention (12 sessions in 4 months) is based on the Packer group program and was given by occupational therapists. The control intervention (3 sessions in 4 months) consisted of MS-nurse consultations. Method: Primary outcome measures were Fatigue (Checklist Individual Strength-CIS20r domain subjective experience of fatigue) and participation (Impact on Participation and Autonomy- IPA). Additional secondary outcome measures on fatigue, activity and participation were done. Measurements, evaluated by blinded assessors, were at baseline and 8, 16, 26 and 52 weeks after randomization. Linear Mixed Models analyses with a three level structure (repeated measures, patients and therapists) were performed. Results: Intention to treat analysis was based on 76 patients (ECM n=36; MS-nurse n=40). No significant intervention effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% CI -3.71 to 2.11; p=0.58), and for four out of five IPA domains. For the IPA domain social relations, an overall unfavorable effect for the ECM group was found (difference between the groups = 0.19, 95% CI 0.03 to 0.35, p=0.02). Conclusion: Energy conservation management does not lead to significant and clinically relevant changes in fatigue and participation compared to MS nurse consultations. Although both treatments achieved a statistically significant decline of fatigue during the treatment period, and for the ECM group also at long-term followup, these effects must be considered as clinically non-relevant