Prerecorded Autosuggestion in Long-standing Pain Intervention (PALPI)

July 15, 2011 updated by: Free University Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Free University Brussels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)
Time Frame: 1 month
1 month
Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)
Time Frame: 3 months
3 months
McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Free University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dirk Devroey, Free University Brussels

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.U.N. B14320096694

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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