Prerecorded Autosuggestion in Long-standing Pain Intervention

NCT ID: NCT01039727

Last Updated: 2011-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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The first objective of this thesis is to investigate the hypothesis that prerecorded autosuggestion (PA) can be a theoretically valuable (efficacy) and practical (efficiency) tool in the care of many patients with chronic pain. With a prevalence in chronic pain conditions of +/- 20% of adults, chronic pain is a huge problem for individuals as well as for society, absorbing an enormous amount of resources. Even with all available treatments, many people still suffer from chronic pain, in particular when this pain has a psychosomatic ('functional') origin. In the PALPI study (Prerecorded Autosuggestion in Long-standing Pain Intervention), accompanying this thesis, efforts are made to mainly involve chronic pain of clearly psychosomatic origin.

Detailed Description

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A number of GPs will be contacted. A working definition of 'chronic pain patient' is put forward. Only patients with chronic pain for which present research suspects a substantial degree of psychosomatic causality are withheld. A randomization of these into three groups is performed by the appropriate department of the VUB. The three groups are: a control group (receiving 'care as usual'), a group receiving additionally to care as usual, 5 autosuggestion CDs (containing +/- 25 different sessions of autosuggestion) and a group receiving additionally to care as usual, email assistance (through a specific internet module), including downloadable CDs as appropriate and access to 'AurelisOnLine' (an internet application with \> 900 different sessions of autosuggestion). Three of the CDs contain pre-recorded sessions of relaxation + autosuggestion aimed at diminishing pain. Other CDs are about relaxation, general wellness, etc. Each arm of investigation contains 30 subjects. Assessments are made at 3 points in time: at the start, at 1 month from the start and at 3 months from the start. The following will be measured: quality of life (through a Dutch version of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)), levels of pain intensity and quality (through a Dutch version of the McGill Pain Questionnaire (SF-MPQ)) and use of painkillers. In addition to this, the acceptance/satisfaction of physicians and patients of this kind of treatment will also be the subject of this investigation.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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care as usual

care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

autosuggestive support

care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')

Group Type EXPERIMENTAL

care as usual + 5 specific CDs

Intervention Type OTHER

care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')

autosuggestive support ++

care as usual + email assistance (password protected) + AurelisOnLine (AoL) + 5 CDs at the start (same as in arm 2) + more CDs as needed after 1 month

Group Type EXPERIMENTAL

care as usual + email assistance + AurelisOnLine (AoL) + CDs

Intervention Type OTHER

care as usual + email assistance (password protected) + AurelisOnLine (AoL) + 5 CDs at the start (same as in arm 2) + more CDs as needed after 1 month

Interventions

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care as usual + 5 specific CDs

care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')

Intervention Type OTHER

care as usual + email assistance + AurelisOnLine (AoL) + CDs

care as usual + email assistance (password protected) + AurelisOnLine (AoL) + 5 CDs at the start (same as in arm 2) + more CDs as needed after 1 month

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The subject is aged \> 18 years.
* The subject is a 'chronic pain patient': at least 3 months of almost daily pain.
* The subject has one of the following syndromes and has been sufficiently investigated upon it in order to exclude a physical medical cause:

* chronic low back pain
* chronic thoracic pain
* chronic neck pain
* fibromyalgia
* temporomandibular pain dysfunction (TMPD)
* complex regional pain syndrome (CRPS) = RSD
* chronic tension-type headache
* chronic pelvic pain
* painful bladder syndrome
* irritable bowel syndrome
* vulvodynia
* The subject has a fast internet connection with possibility to download and burn CDs and/or copy mp3s on an mp3-player (or knows someone who is willing to take care of this)
* The subject has a CD and/or mp3 player at disposal or will buy one.

As an additional 'inclusion criterion', we explicitly ask the referring physician to include preferably patients whom he would otherwise also advise PALPI.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Free University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Free University Brussels

Principal Investigators

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Dirk Devroey

Role: STUDY_CHAIR

Université Libre de Bruxelles

Locations

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Free University Brussels

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jean-Luc Mommaerts, M.D.

Role: CONTACT

0032 3 289 04 43

Other Identifiers

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B.U.N. B14320096694

Identifier Type: -

Identifier Source: org_study_id

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