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Prerecorded Autosuggestion in Long-standing Pain Intervention (PALPI)

This study is not yet open for participant recruitment.
Verified July 2011 by Free University Medical Center
Sponsor:
Information provided by:
Free University Medical Center
ClinicalTrials.gov Identifier:
NCT01039727
First received: December 24, 2009
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Other: care as usual + 5 specific CDs
Other: care as usual + email assistance + AurelisOnLine (AoL) + CDs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prerecorded Autosuggestion in Long-standing Pain Intervention

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Free University Medical Center:

Primary Outcome Measures:
  • McGill Pain Questionnaire - Dutch language Version (MPQ-DLV) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • McGill Pain Questionnaire - Dutch language Version (MPQ-DLV) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: care as usual
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039727

Contacts
Contact: Jean-Luc Mommaerts, M.D. 0032 3 289 04 43 jeanluc@aurelis.org

Locations
Belgium
Free University Brussels Not yet recruiting
Brussels, Belgium
Principal Investigator: Jean-Luc Mommaerts, M.D.            
Sponsors and Collaborators
Free University Medical Center
Investigators
Study Chair: Dirk Devroey Free University Brussels
  More Information

No publications provided

Responsible Party: Dr. Jean-Luc Mommaerts, M.D., M.Sc., Free University Brussels
ClinicalTrials.gov Identifier: NCT01039727     History of Changes
Other Study ID Numbers: B.U.N. B14320096694
Study First Received: December 24, 2009
Last Updated: July 15, 2011
Health Authority: Belgium: Free University Brussels

Keywords provided by Free University Medical Center:
Pain [C10.597.617]

ClinicalTrials.gov processed this record on May 22, 2013