Prerecorded Autosuggestion in Long-standing Pain Intervention (PALPI)

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: care as usual + 5 specific CDs; Other: care as usual + email assistance + AurelisOnLine (AoL) + CDs

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Free University Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: care as usual
Experimental: autosuggestive support; care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')	Other: care as usual + 5 specific CDs; care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Free University Medical Center
• Investigators: Study Chair: Dirk Devroey, Free University Brussels

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 24, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Pain [C10.597.617]
• Other Study ID Numbers: B.U.N. B14320096694