This study will be the first controlled study specifically investigating the effect of EMDR on FM pain and additional physical symptoms.
ID
Source
Brief title
Condition
- Joint disorders
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily data are collected of the primary parameter which is pain intensity.
Secondary outcome
Secondary parameters are stiffness in muscles and joints, fatigue, the impact
of pain on daily life, the impact of pain on sleep and a selection of four PTSD
symptoms.
Exploratory analysis:
At specific time points data will be collected of the impact of FM complaints
on daily life, PTSD symptoms, psychiatric symptoms and functioning in general,
depressive symptoms, central sensitization symptoms and the patient impression
of change. The time points are at the start of the baseline, at the end of the
baseline period which corresponds to the start of the intervention, directly
after the EMDR treatment, one month after the EMDR treatment and three months
after the EMDR treatment.
Background summary
Fibromyalgia (FM) is a disabling chronic pain syndrome characterized by
multi-site pain, stiffness, fatigue and sleeping problems. Symptoms of central
sensitization are common in FM as are post-traumatic stress symptoms. Eye
Movement Desensitization and Reprocessing Therapy (EMDR) is an evidence-based
treatment for post-traumatic stress disorder (PTSD). Evidence is mounting that
chronic pain can also be treated with EMDR. However, to date no controlled
studies have been conducted specifically targeting EMDR for FM. Based on
previous research it is hypothesized that EMDR may reduce pain intensity in
patients with FM.
Study objective
This study will be the first controlled study specifically investigating the
effect of EMDR on FM pain and additional physical symptoms.
Study design
A non-concurrent, multiple-baseline single-case experimental design (SCED)
which will be replicated ten times. Participants are randomly assigned to one
of three time series and also the start of the intervention within the time
series is randomly determined.
Intervention
EMDR therapy consists of seven sessions of 90 minutes in total, performed
according to the EMDR standard protocol. EMDR focuses on processing traumatic
memories and pain-related memories.
Study burden and risks
If the therapy is effective, pain intensity decreases, additional physical
complaints of FM decrease and patients experience less discomfort from their
pain in daily life. EMDR therapy is an evidenced based treatment for PTSD and
reduction of posttraumatic stress favors recovery of physical complaints.
Participating in the study includes attending the EMDR therapy sessions (seven
times 90 minutes), two conversations for inclusion (two times 60 minutes
consisting of one telephone conversation and one face-to-face conversation),
daily registration of complaints (about two minutes per day, including
registering possible daily medication intake) via a smartphone application, and
completing the questionnaires (about 20-30 minutes at five specific time points
during the study). If necessary, a test of intellectual functioning will be
done at before inclusion, which takes 2-3 hours. The daily registration and
study will take a minimum period of 15 weeks to a maximum period of 17 weeks.
At three-months follow-up patients will be asked to register daily for 14 days.
In total, this makes a total burden of 22 to 25 hours with an estimated total
of filling in daily registrations and questionnaires of around 9 hours. EMDR
sessions can be emotionally intense, but never are as challenging as living
with unprocessed (traumatic) pain related memories. There are no risks
associated with EMDR therapy.
Stationsplein 138
Heerhugowaard 1703 WC
NL
Stationsplein 138
Heerhugowaard 1703 WC
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
1) a medical diagnosis of fibromyalgia
2) age of 18 years and older
3) an average pain intensity score in the past week of >= 7 on a Numerical
Rating Scale for Pain
4) sufficient understanding of the Dutch language verbally and in writing, in
order to be able to participate
5) willingness to participate in the study (as indicated by the signed informed
consent)
Exclusion criteria
Exclusion criteria:
1) an acute condition of psychosis or bipolar disorder
2) an acute suicidal risk
3) an IQ < 80
4) substance dependency
5) stable on use of medication. Medication was not started less than 3 months
ago (e.g. psychotropic drugs, analgetics or other medication with effect on
pain or symptoms of fibromyalgia). If medication was started more than 3 months
ago, medication can be continued. We will ask patients to keep their medication
prescriptions as stable as possible during the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76917.029.21 |