Multiple Sclerosis Journal - October 2017 - 1532

Multiple Sclerosis Journal 23(11)
Table 2. Participant characteristics of people with MS allocated to ECM or control group.

No. of males/females
Age (years), mean (SD)
No type MS; RR/PP/SP/unknown
Years since diagnosis
EDSS
Treatment adherence

ECM (N = 42)

Control group (N = 44)

8/34
47.7 (11.0)
32/2/7/1
6.5 (3.7-17.3)
2.5 (2-4)
83%

14/30
46.6 (11.5)
32/4/7/1
7.5 (3-14)
1.8 (1-4)
86%

MS: multiple sclerosis; ECM: energy conservation management; SD: standard deviation; EDSS: Expanded Disability Status Scale;
RR: relapsing-remitting; PP: primary progressive; SP: secondary progressive.
Values in median (Q1-Q3) or as otherwise stated.

1532

Discussion
The aim of this study was to evaluate the effectiveness of an individual ECM intervention on fatigue
and participation in fatigued persons with MS. An
individual ECM intervention provided by an occupational therapist was compared to a control condition
that consisted of MS nurse consultations. No betweengroup differences were found for fatigue (measured
with the subjective fatigue domain of the CIS20r) and
participation (measured with the IPA). Similar results
were found for secondary outcomes, that is, non-significant and non-clinically relevant effects. Based on
these findings, our study does not support the implementation of our individual ECM format as a treatment for MS-related fatigue.

Explanations for the lack of significant differences
between the ECM and the control group on the primary outcomes might include earlier experience with
ECM longer than 3 months ago. In all, 20% of the
included participants (10 in the intervention and 8 in
the control group) had earlier experiences with ECM
strategies, and this may have resulted in less improvement during the treatment period as these strategies
may have already been applied to relieve fatigue.
However, 85% of the patients in the ECM group
implemented over six ECM strategies and perceived
the applied strategies as effective. This level is comparable to levels reported in other studies.32,33
Therefore, we consider it unlikely that earlier experience of ECM was an important effect modifier.

The results of our study are not completely in agreement with the known literature. A previous review15
of ECM studies10-12,29 showed that MS-related fatigue
was effectively improved by the ECM group programme on short-term follow-up, while long-term
evaluation suggested that these effects sustained.
However, in contrast to our study, these studies compared the ECM group with a no-treatment waitlist
control group.10-12,14 Moreover, in the studies with a
large sample size,10,11,14 the between-group differences were statistically significant but very small
from a clinical perspective. Studies that used comparable control groups (e.g. peer support, attention)30,31
reported outcomes in line with our results: no additional effect of the ECM. In another category of studies, studies including energy management as part of a
multidisciplinary rehabilitation treatment,6,7 again no
significant difference on fatigue was found in comparison to a control group. However, it should be
noted that direct comparison between our study and
other studies is difficult, due to differences in control
group content, the format of ECM (e.g. individual vs
group), patient enrolment criteria and differences in
the used outcome measures.

Although the instruments in our study were carefully
selected, and measurements were precise and standardized, self-reported questionnaires may show insufficient responsiveness. For example, Rietberg et al.34
reported low responsiveness for the CIS20r, with a
smallest detectable change of 11.8 for CIS20r fatigue
in MS. The IPA also showed small to moderate
response means; however, the clinimetric properties
for persons with MS are still unknown. Nevertheless,
the results of secondary outcomes in our study show
similar patterns and therefore do not support a possible lack of responsiveness of CIS20r fatigue and IPA.
Although our results clearly showed no differences
between the study groups on fatigue outcomes,
within-group analyses (Supplement 3) showed statistically significant differences on fatigue between
baseline and post-intervention (T16) and between
baseline and long-term follow-up for the ECM group.
Nevertheless, these effects were below the predefined
'clinical relevance' threshold of 8 points on the
CIS20r fatigue subscale16 and therefore considered as
clinically not relevant. However, the 8-point threshold is rather arbitrary than evidence-based. On the

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