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

Sponsor
Region Jönköping County (Other)
Overall Status
Completed
CT.gov ID
NCT01734876
Collaborator
University Hospital, Linkoeping (Other)
45
Enrollment
1
Location
2
Arms
63
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Tactile Touch
  • Behavioral: Rest To Music
 N/A

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

Study Type:
Interventional
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 :
Sep 1, 2004
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    Primary Outcome Measures

    1. Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain [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 [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 [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

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 FUTURUM Jönköping Sweden SE 551 85

    Sponsors and Collaborators

    • Region Jönköping County
    • University Hospital, Linkoeping

    Investigators

    • Principal Investigator: Carl Jo Törnhage, MD, PhD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Region Jönköping County
    ClinicalTrials.gov Identifier:
    NCT01734876
    Other Study ID Numbers:
    • D 03-673
    • FUTURUM 254481
    First Posted:
    Nov 28, 2012
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Nov 1, 2012
    Keywords provided by Region Jönköping County
    Parkinson´s disease
    Pain
    Sleep
    HPA axis function
    Health Related Quality of Life
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Oct 8, 2020