We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prerecorded Autosuggestion in Long-standing Pain Intervention (PALPI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Free University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039727
First Posted: December 25, 2009
Last Update Posted: July 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Free University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prerecorded Autosuggestion in Long-standing Pain Intervention

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 ]

Secondary Outcome Measures:
  • Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) [ Time Frame: 1 month ]
  • Multidimensional Pain Inventory - Dutch language Version (MPI-DLV) [ Time Frame: 3 months ]
  • McGill Pain Questionnaire - Dutch language Version (MPQ-DLV) [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 24, 2009
First Posted: December 25, 2009
Last Update Posted: July 18, 2011
Last Verified: July 2011

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