Prerecorded Autosuggestion in Long-standing Pain Intervention

Pain Clinical Trial

— PALPI  

Official title:

Prerecorded Autosuggestion in Long-standing Pain Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01039727
• Other study ID #: B.U.N. B14320096694
• Status: Not yet recruiting
• Phase: N/A
• First received: December 24, 2009
• Last updated: July 15, 2011
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2011
• Source: Free University Medical Center
• Contact: Jean-Luc Mommaerts, M.D.
• Phone: 0032 3 289 04 43
• Email: jeanluc[@]aurelis.org
• Is FDA regulated: No
• Health authority: Belgium: Free University Brussels
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	Free University Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Free University Medical Center

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)		1 month	No
Secondary	Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)		1 month	No
Secondary	Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)		3 months	No
Secondary	McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)		3 months	No