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Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01865097
Recruitment Status : Unknown
Verified November 2014 by Dr. Ilana Schlesinger, Rambam Health Care Campus.
Recruitment status was:  Enrolling by invitation
First Posted : May 30, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Ilana Schlesinger, Rambam Health Care Campus

Study Description
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Brief Summary:
Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome non-motor symptom is pain. Currently these symptoms are treated with medication with limited success. Our study aims to determine whether relaxation guided imagery can alleviate pain in Parkinson's disease patients.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Relaxation guided imagery Behavioral: Relaxing music Phase 1

Detailed Description:
Parkinson's disease patients with severe pain without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on pain. This will be a phase I, controlled, single blind and randomized efficacy study in 2 parallel groups. The study will include a baseline assessment of pain severity where after the intervention group will undergo relaxation guided imagery and the control group will listen to relaxing music. After these relaxation session patients will receive a CD with either relaxation guided imagery or relaxing music to listen to at home. Pain severity will be recorded for the following 6 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease
Study Start Date : June 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Relaxation guided imagery Behavioral: Relaxation guided imagery
An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the relaxation guided imagery and asked to listen to it at home.
Active Comparator: Relaxing music Behavioral: Relaxing music
An individualized session of listening to relaxing music will be conducted. After the session patients will be given a CD with the relaxing music and asked to listen to it at home.


Outcome Measures
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Primary Outcome Measures :
  1. Pain scores on the visual analog scale [ Time Frame: 6 weeks ]
    Numeric rating scale after relaxation guided imagery as compared with baseline


Secondary Outcome Measures :
  1. The brief Pain Inventory [ Time Frame: 6 weeks ]
    The brief Pain Inventory after relaxation guided imagery as compared with baseline


Other Outcome Measures:
  1. Health status measured by Parkinson's Disease Questionnaire 39(PDQ39) [ Time Frame: 6 weeks ]
    PDQ39 after relaxation guided imagery as compared with baseline

  2. Depression scores on Beck Depression Inventory (BDI) [ Time Frame: 6 weeeks ]
    BDI after relaxation guided imagery as compared with baseline

  3. Non-motor symptom screening questionaire [ Time Frame: 6 weeks ]
    Non-motor symptom screening questionaire after relaxation guided imagery as compared with baseline


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic Parkinson's disease suffering from significant pain.

Exclusion Criteria:

  • Dementia
  • Hearing impairment
Contacts and Locations
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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): NCT01865097


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Ilana Schlesinger, M.D. Rambam Health Care Campus, Haifa, Israel
More Information
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Responsible Party: Dr. Ilana Schlesinger, Director, Movement Disorders Center, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01865097     History of Changes
Other Study ID Numbers: 0494-12
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Keywords provided by Dr. Ilana Schlesinger, Rambam Health Care Campus:
Imagery
Pain
Depression
Non-Motor
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases