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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.

Conditions
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Pain, Sleep

Intervention / Treatment
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* Behavioral: Tactile Touch
* Behavioral: Rest To Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson´s Disease chronic pain Exclusion Criteria: Epilepsy Active malignancy Diabetes mellitus Parkinson´s disease in complication phase

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tactile Touch<br>Tactile Touch is given to the active arm | Behavioral: Tactile Touch<br>* 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.<br>* Other names: massage therapy;Behavioral: Rest To Music<br>* Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.<br>|
| Active Comparator: Rest To Music<br>Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position | Behavioral: Tactile Touch<br>* 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.<br>* Other names: massage therapy;Behavioral: Rest To Music<br>* Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Within 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson´s disease, Pain, Sleep, HPA axis function, Health Related Quality of Life