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

This study has been completed.
Sponsor:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life  This link exits the ClinicalTrials.gov site
Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations  This link exits the ClinicalTrials.gov site

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 
Study First Received: November 11, 2012
Last Updated: November 27, 2012
Health Authority: Sweden: Regional Ethical Review Board

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 27, 2016