The primary objective is to investigate the feasibility of using counterconditioning as a novel treatment method aimed to reduce pain in female fibromyalgia patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fibromyalgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the feasibility of the counterconditioning
intervention. This will be done by looking at the drop-out rate, by measuring
participant*s satisfaction with the intervention; by examing what, according to
the participants, is causing the possible increase and reduction of
experimentally evoked pressure pain in the test phase of (counter)conditioning
(e.g., the TENS device, the placebo or nocebo effect); by exploring the amount
of experimentally-evoked pressure pain reported during the test phase of
counterconditioning, whether this reduces over time, as well as the speed of
this reduction.
Secondary outcome
Not applicable.
Background summary
Treatment opportunities for persistent physical symptoms, such as chronic pain,
are currently limited. It is suggested that nocebo effects (i.e. adverse
outcomes not attributable to an active treatment, putatively mediated by
negative expectations) can negatively influence symptom progression. With
procedures of counterconditioning, combined with verbal suggestions, previously
learned associations (causing negative expectations) between different stimuli
can be reversed. Therefore, counterconditioning could provide an innovative
method for reducing physical symptoms. In the current study, the feasibility of
using counterconditioning methods as a novel intervention for reducing pain
symptoms will be examined in a clinical population of fibromyalgia patients.
Study objective
The primary objective is to investigate the feasibility of using
counterconditioning as a novel treatment method aimed to reduce pain in female
fibromyalgia patients.
Study design
A randomized, controlled, between-within-subjects study design will be used.
Participants will be randomly assigned to one of two conditions: 1) a 6-week
counterconditioning intervention, or 2) a 6-week control condition using sham
conditioning (attention control). Feasability of the intervention (e.g.,
satistfaction of participants, drop-out rate) will be investigated.
Additionally, experimentally-evoked pressure pain and clinical outcome measures
will be explored during weekly lab sessions for 6 weeks and again at a 3- and
6-month follow up.
Intervention
Counterconditioning methods will be used for desensitization of pain symptoms
in the intervention group. Participants in the intervention group will
participate in a conditioning procedure once, in order to ensure that a
specific association with the primary symptom of pain can be
counterconditioned. Participants will be given homework exercises to strengthen
the intervention and promote generalization of symptom desensitization to
everyday life.
Study burden and risks
Multiple studies have used pressure pain in fibromyalgia patients and no risks
are associated with using pressure pain devices. Since we will be using a
conditioning procedure in the first session, pain might show a temporary
increase, but because counterconditioning procedures will follow immediately,
this increase will be very short-lived. This study might show indications that
this intervention could be effective in this difficult-to-treat patient group.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of fibromyalgia (provided by GP or medical specialist)
Current pain symptoms because of fibromyalgia
>= 18 years old female
Good understanding of written and spoken Dutch
Exclusion criteria
Physical conditions other than fibromyalgia explaining pain symptoms;
Psychiatric conditions not related to the fibromyalgia symptoms (e.g.,
schizophrenia);
Pregnancy or lactation;
Refusal to remove artificial nails, nail polish, or any other substance
covering the thumbnail;
Having metal-containing implants in the non-dominant arm (including
non-removable piercings);
Carrying a pacemaker or implanted pumps;
Injuries/open wounds on the non-dominant arm
Not being able to clearly distinguish between three different pressure pain
intensities during testing
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66812.058.18 |
| OMON | NL-OMON27907 |