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Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease

Primary Purpose

Pain, Sleep

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tactile Touch
Rest To Music
Sponsored by
Region Jönköping County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Parkinson´s disease, Pain, Sleep, HPA axis function, Health Related Quality of Life

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson´s Disease
  • chronic pain

Exclusion Criteria:

  • Epilepsy
  • Active malignancy
  • Diabetes mellitus
  • Parkinson´s disease in complication phase

Sites / Locations

  • FUTURUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tactile Touch

Rest To Music

Arm Description

Tactile Touch is given to the active arm

Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position

Outcomes

Primary Outcome Measures

Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain
HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).

Secondary Outcome Measures

Effect of Tactile Touch on HRQoL
As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)

Full Information

First Posted
November 11, 2012
Last Updated
October 6, 2020
Sponsor
Region Jönköping County
Collaborators
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT01734876
Brief Title
Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
Official Title
Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Jönköping County
Collaborators
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality of Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or only Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10 weeks was the intervention period , followed by a follow-up period. Outcome measures were salivary cortisol concentration measured at seven occasions of which two were immediately before, after and 30 minutes after intervention. Diurnal salivary cortisol was calculated based on four timepoints of sampling per 24 hour period.
Detailed Description
This study was initiated by the massage therapists who had experienced pain reduction in parkinsonian patients when usin Tactile Touch. As the method consisted of a combination of Music Therapy and Aroma therapy we chose just to study the effects of the Tactile Touch. HrQOL was measured using SF-36 (Swe.ver.1) sleep was measured with the PDSS scale, pain wit VAS 10 cm scale and the Pain-O.Meter. All measures were repeated during the study period. Patients were not allowed to change their basic antiparkinson medication.All drugs were carefully registered and supervised by specialists in neurology at the three different study sites in Southern Sweden. The massage technique was described in a 11 A4 pages long description and the same method was used at all three sites. The same aroma oils, same temperature in the rooms and the same music was used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Sleep
Keywords
Parkinson´s disease, Pain, Sleep, HPA axis function, Health Related Quality of Life

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tactile Touch
Arm Type
Experimental
Arm Description
Tactile Touch is given to the active arm
Arm Title
Rest To Music
Arm Type
Active Comparator
Arm Description
Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position
Intervention Type
Behavioral
Intervention Name(s)
Tactile Touch
Other Intervention Name(s)
massage therapy
Intervention Description
Tactile Touch was performed for 10 times during a 8 week period.The method consists of a superficial whole body tactile touch, following a structural scheme. Participants in a horizontal position, in a tempered room. Aroma of lavendar and quiet music in the background.
Intervention Type
Behavioral
Intervention Name(s)
Rest To Music
Intervention Description
Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
Primary Outcome Measure Information:
Title
Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain
Description
HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).
Time Frame
Within 1 year
Secondary Outcome Measure Information:
Title
Effect of Tactile Touch on HRQoL
Description
As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)
Time Frame
Within 1 year
Other Pre-specified Outcome Measures:
Title
The Parkitouch Study
Description
Are Tactile Touch more effective than Rest to Music in reducing patients´ chronic stress in terms of lowering salivary cortisol secretion in short and / or long term perspective? Is the treatment safe and well tolerated? Does sleep quality improve and is sleep fragmentaion reduced? Is HRQoL improved?
Time Frame
Wihin 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson´s Disease chronic pain Exclusion Criteria: Epilepsy Active malignancy Diabetes mellitus Parkinson´s disease in complication phase
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Jo Törnhage, MD, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
FUTURUM
City
Jönköping
ZIP/Postal Code
SE 551 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21887109
Citation
Skogar O, Fall PA, Hallgren G, Lokk J, Bringer B, Carlsson M, Lennartsson U, Sandbjork H, Tornhage CJ. Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations. Int J Gen Med. 2011;4:561-9. doi: 10.2147/IJGM.S20875. Epub 2011 Aug 10.
Results Reference
result
PubMed Identifier
23091387
Citation
Skogar O, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson U, Sandbjork H, Tornhage CJ, Lokk J. Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and health-related quality of life. Neuropsychiatr Dis Treat. 2012;8:435-42. doi: 10.2147/NDT.S34882. Epub 2012 Oct 12.
Results Reference
result
PubMed Identifier
24330473
Citation
Tornhage CJ, Skogar O, Borg A, Larsson B, Robertsson L, Andersson L, Andersson L, Backstrom P, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson UB, Sandbjork H, Lokk J. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson's disease: a randomised controlled pilot study. BMC Complement Altern Med. 2013 Dec 13;13:357. doi: 10.1186/1472-6882-13-357.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=Parkinson%E2%80%99s%20disease%20patients%E2%80%99%20subjective%20descriptions%20of%20characteristics%20of%20chronic%20pain%2C%20sleeping%20patterns%20and%20Health%20Related%20Quality%20of%20Life
Description
Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160865/
Description
Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations

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Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease

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