Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
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| ClinicalTrials.gov Identifier: NCT01734876 |
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Recruitment Status :
Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Sleep | Behavioral: Tactile Touch Behavioral: Rest To Music | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 45 participants |
| 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. |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tactile Touch
Tactile Touch is given to the active arm
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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. |
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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
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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. |
- 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).
- 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)
- 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?
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| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Parkinson´s Disease
- chronic pain
Exclusion Criteria:
- Epilepsy
- Active malignancy
- Diabetes mellitus
- Parkinson´s disease in complication phase
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): NCT01734876
| Sweden | |
| FUTURUM | |
| Jönköping, Sweden, SE 551 85 | |
| Principal Investigator: | Carl Jo Törnhage, MD, PhD |
Additional Information:
Publications of Results:
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 ) |
| First Posted: | November 28, 2012 Key Record Dates |
| Last Update Posted: | November 28, 2012 |
| Last Verified: | November 2012 |
Keywords provided by FUTURUM, Academy of Health and Science:
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Parkinson´s disease Pain Sleep HPA axis function Health Related Quality of Life |
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 |