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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01865097
• Other study ID #: 0494-12
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: May 19, 2013
• Last updated: November 5, 2014
• Start date: June 2013

Study information

• Verified date: November 2014
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Dementia

• Hearing impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health status measured by Parkinson's Disease Questionnaire 39(PDQ39)	PDQ39 after relaxation guided imagery as compared with baseline	6 weeks	No
Other	Depression scores on Beck Depression Inventory (BDI)	BDI after relaxation guided imagery as compared with baseline	6 weeeks	No
Other	Non-motor symptom screening questionaire	Non-motor symptom screening questionaire after relaxation guided imagery as compared with baseline	6 weeks	No
Primary	Pain scores on the visual analog scale	Numeric rating scale after relaxation guided imagery as compared with baseline	6 weeks	No
Secondary	The brief Pain Inventory	The brief Pain Inventory after relaxation guided imagery as compared with baseline	6 weeks	No