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NCT Number: NCT02038244

Integrative Medicine for Chronic Pain

In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.

Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with any chronic pain condition
  • at least 6 months pain duration
  • written informed consent

Exclusion criteria

  • participation in any other clinical study

Treatment and study plan

Multimodal integrative medicine inpatient treatment program

Other

Primary outcomes

  1. Pain Intensity

    Time frame: 14 days

    VAS

Secondary outcomes

  1. Pain Intensity

    Time frame: 6 months

    VAS

  2. Pain Disability

    Time frame: 14 days, 6 months

    • German Pain Questionnaire

  3. Health-related quality of life

    Time frame: 14 days, 6 months

    Short Form (36) Health Survey

  4. Life satisfaction

    Time frame: 14 days, 6 months

    Brief Multidimensional Life Satisfaction Scale

  5. Depression

    Time frame: 14 days, 6 months

    Beck Depression Inventory

  6. Acceptance

    Time frame: 14 days, 6 months

    Emotional/Rational Disease Acceptance Questionnaire

  7. Mindfulness

    Time frame: 14 days, 6 months

    Conscious Presence and Self Control (CPSC) Scale

  8. Subjective stress

    Time frame: 14 days, 6 months

    Perceived Stress Scale

  9. Easiness of life

    Time frame: 14 days, 6 months

    Questionnaire on emotional and physical reactions

  10. Ability and will to change

    Time frame: 14 days, 6 months

    Ability and will to change Questionnaire

  11. Safety

    Time frame: 14 days, 6 months

    Adverse events

  12. Pain Disability

    Time frame: 14 days, 6 months

    • Pain Disability Index

Other outcomes

  1. Body awareness

    Time frame: 14 days, 6 months

    Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.

    • Body Awareness Questionnaire (BAQ) (Shields 1989)

  2. Body responsiveness

    Time frame: 14 days, 6 months

    Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.

    • Body Responsiveness Scale (BRS)(Daubenmier 2005)

  3. Body awareness and dissociation

    Time frame: 14 days, 6 months

    Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.

    • Scale of Body Connection (SBC) (Price and Thompson 2007)

  4. Postural awareness

    Time frame: 14 days, 6 months

    Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.

    • Postural Awareness Scale (PAS) (Cramer et al.)

  5. Body awareness

    Time frame: 14 days, 6 months

    The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes.

    • Dresden Body Image Questionnaire (DKB) (Pöhlmann et al., 2007)

  6. Daily log

    Time frame: 2 weeks

    Daily rating of pain and well-being on a 100mm visual analog scale.

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Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • University of Witten/Herdecke

Registry information

Official study title

Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine

Acronym: POSITIVE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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