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

Not Applicable

Completed

• Conditions: Pain; Sleep
• Interventions: Behavioral: Tactile Touch; Behavioral: Rest To Music

• Registration Number: NCT01734876
• Lead Sponsor: Region Jönköping County

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.

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 Timeline

• Study Start: 2004-09
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2012-11
• Study First Submitted: 2012-11-11
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Parkinson´s Disease
• chronic pain

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tactile Touch	Rest To Music	Tactile Touch is given to the active arm
Rest To Music	Rest To Music	Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position
Rest To Music	Tactile Touch	Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position
Tactile Touch	Tactile Touch	Tactile Touch is given to the active arm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

FUTURUM; 🇸🇪 Jönköping, Sweden