NCT01039727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

December 24, 2009

Last Update Submit

July 15, 2011

Conditions

Pain

Keywords

Pain [C10.597.617]

Outcome Measures

Primary Outcomes (1)

  • McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)

    1 month

Secondary Outcomes (3)

  • 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

Study Arms (3)

care as usual

NO INTERVENTION

care as usual

autosuggestive support

EXPERIMENTAL

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

Other: care as usual + 5 specific CDs

autosuggestive support ++

EXPERIMENTAL

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

Interventions

care as usual + 5 specific CDsOTHER

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

autosuggestive support
care as usual + email assistance + AurelisOnLine (AoL) + CDsOTHER

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

autosuggestive support ++

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Free University Brussels

Brussels, Belgium

Location

MeSH Terms

Conditions

Pain

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Videodisc RecordingOptical Storage DevicesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Dirk Devroey

    Université Libre de Bruxelles

    STUDY CHAIR

Central Study Contacts

Jean-Luc Mommaerts, M.D.

CONTACT

0032 3 289 04 43jeanluc@aurelis.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 25, 2009

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2013

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

BE(1)