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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Pain; Sleep	Behavioral: Tactile Touch; Behavioral: Rest To Music	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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:

1. 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?

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life 

Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations 

Publications of Results:

Skogar O, Fall PA, Hallgren G, Lökk J, Bringer B, Carlsson M, Lennartsson U, Sandbjork H, Törnhage 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.

Skogar O, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson U, Sandbjörk H, Törnhage CJ, Lökk 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Törnhage CJ, Skogar Ö, Borg A, Larsson B, Robertsson L, Andersson L, Andersson L, Backström P, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson UB, Sandbjörk H, Lökk 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.

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
Last Update Posted:	November 28, 2012
Last Verified:	November 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