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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734876
• Other study ID #: D 03-673
• Secondary ID: FUTURUM 254481
• Status: Completed
• Phase: N/A
• Start date: September 2004
• Est. completion date: December 2009

Study information

• Verified date: November 2012
• Source: Region Jönköping County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Parkinson´s Disease

• chronic pain

Exclusion Criteria:

• Epilepsy

• Active malignancy

• Diabetes mellitus

• Parkinson´s disease in complication phase

Related Conditions & MeSH terms

• Pain
• Parkinson Disease
• Sleep

Intervention

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

Locations

Country	Name	City	State
Sweden	FUTURUM	Jönköping

Sponsors (2)

Lead Sponsor	Collaborator
Region Jönköping County	University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. Neuropsy — View Citation

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;4:56 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Parkitouch Study	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?	Wihin 1 year
Primary	Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain	HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).	Within 1 year
Secondary	Effect of Tactile Touch on HRQoL	As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)	Within 1 year

External Links

•   Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations
•   Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life