Prerecorded Autosuggestion in Long-standing Pain Intervention

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

Official Title
-----------------
Prerecorded Autosuggestion in Long-standing Pain Intervention

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: care as usual + 5 specific CDs
* Other: care as usual + email assistance + AurelisOnLine (AoL) + CDs


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: care as usual<br>care as usual | |
| Experimental: autosuggestive support<br>care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations') | Other: care as usual + 5 specific CDs<br>* care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')<br>|
| Experimental: autosuggestive support ++<br>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 | Other: care as usual + email assistance + AurelisOnLine (AoL) + CDs<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire - Dutch language Version (MPQ-DLV) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) |  | 1 month | 
| Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) |  | 3 months | 
| McGill Pain Questionnaire - Dutch language Version (MPQ-DLV) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain [C10.597.617]