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Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
This study has been completed.
Sponsor:
FUTURUM, Academy of Health and Science
Collaborator:
University Hospital, Linkoeping
Information provided by (Responsible Party):
FUTURUM, Academy of Health and Science
ClinicalTrials.gov Identifier:
NCT01734876
First received: November 11, 2012
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| Pain Sleep | Behavioral: Tactile Touch Behavioral: Rest To Music |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
| Official Title: | Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease. |
Resource links provided by NLM:
Further study details as provided by FUTURUM, Academy of Health and Science:
Primary Outcome Measures:
- Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain [ Time Frame: Within 1 year ]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 [ Time Frame: Within 1 year ]As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)
Other Outcome Measures:
- The Parkitouch Study [ Time Frame: Wihin 1 year ]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?
| Enrollment: | 45 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tactile Touch
Tactile Touch is given to the active arm
|
Behavioral: Tactile Touch
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.
Other Name: massage therapy
Behavioral: Rest To Music
Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
|
|
Active Comparator: Rest To Music
Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position
|
Behavioral: Tactile Touch
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.
Other Name: massage therapy
Behavioral: Rest To Music
Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Parkinson´s Disease
- chronic pain
Exclusion Criteria:
- Epilepsy
- Active malignancy
- Diabetes mellitus
- Parkinson´s disease in complication phase
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01734876
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734876
Locations
| Sweden | |
| FUTURUM | |
| Jönköping, Sweden, SE 551 85 | |
Sponsors and Collaborators
FUTURUM, Academy of Health and Science
University Hospital, Linkoeping
Investigators
| Principal Investigator: | Carl Jo Törnhage, MD, PhD |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | FUTURUM, Academy of Health and Science |
| ClinicalTrials.gov Identifier: | NCT01734876 History of Changes |
| Other Study ID Numbers: |
D 03-673 FUTURUM 254481 ( Other Grant/Funding Number: FUTURUM 254481 ) |
| Study First Received: | November 11, 2012 |
| Last Updated: | November 27, 2012 |
Keywords provided by FUTURUM, Academy of Health and Science:
|
Parkinson´s disease Pain Sleep HPA axis function Health Related Quality of Life |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on September 20, 2017