NCT01865097

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

2.5 years

First QC Date

May 19, 2013

Last Update Submit

November 5, 2014

Conditions

Parkinson's Disease

Keywords

ImageryPainDepressionNon-Motor

Outcome Measures

Primary Outcomes (1)

  • Pain scores on the visual analog scale

    Numeric rating scale after relaxation guided imagery as compared with baseline

    6 weeks

Secondary Outcomes (1)

  • The brief Pain Inventory

    6 weeks

Other Outcomes (3)

  • Health status measured by Parkinson's Disease Questionnaire 39(PDQ39)

    6 weeks

  • Depression scores on Beck Depression Inventory (BDI)

    6 weeeks

  • Non-motor symptom screening questionaire

    6 weeks

Study Arms (2)

Relaxation guided imagery

EXPERIMENTAL
Behavioral: Relaxation guided imagery

Relaxing music

ACTIVE COMPARATOR
Behavioral: Relaxing music

Interventions

Relaxation guided imageryBEHAVIORAL

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.

Relaxation guided imagery
Relaxing musicBEHAVIORAL

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.

Relaxing music

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Dementia
  • Hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseasePainDepression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Ilana Schlesinger, M.D.

    Rambam Health Care Campus, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Movement Disorders Center

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 30, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Last Updated

November 6, 2014

Record last verified: 2014-11