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Completed

NCT Number: NCT01734876

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

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.

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Key information

Conditions

Pain Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FUTURUM

Jönköping, SE 551 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson´s Disease
  • chronic pain

Exclusion criteria

  • Epilepsy
  • Active malignancy
  • Diabetes mellitus
  • Parkinson´s disease in complication phase

Treatment and study plan

Tactile Touch

Behavioral

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

Rest To Music

Behavioral

Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.

Primary outcomes

  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 outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

Region Jönköping County

Other Gov

Collaborators

  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Nov 28, 2012
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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