Clinical trial NCT01734876: Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
Official title: Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Sleep
Keywords: Parkinson´s disease
Pain
Sleep
HPA axis function
Health Related Quality of Life
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Linkoeping
First posted: 2012-11-28
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Parkinson´s Disease
* chronic pain

Exclusion Criteria:

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

Primary outcomes:
measure: Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain
timeFrame: Within 1 year
Secondary outcomes:
measure: Effect of Tactile Touch on HRQoL
timeFrame: Within 1 year
Other outcomes:
measure: The Parkitouch Study
timeFrame: Wihin 1 year
Locations:
city: Jönköping
country: Sweden
facility: FUTURUM
Study officials:
name: Carl Jo Törnhage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skogar O, Fall PA, Hallgren G, Lokk J, Bringer B, Carlsson M, Lennartsson U, Sandbjork H, Tornhage CJ. Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations. Int J Gen Med. 2011;4:561-9. doi: 10.2147/IJGM.S20875. Epub 2011 Aug 10.
citation: Skogar O, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson U, Sandbjork H, Tornhage CJ, Lokk J. Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and health-related quality of life. Neuropsychiatr Dis Treat. 2012;8:435-42. doi: 10.2147/NDT.S34882. Epub 2012 Oct 12.
citation: Tornhage CJ, Skogar O, Borg A, Larsson B, Robertsson L, Andersson L, Andersson L, Backstrom P, Fall PA, Hallgren G, Bringer B, Carlsson M, Lennartsson UB, Sandbjork H, Lokk J. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson's disease: a randomised controlled pilot study. BMC Complement Altern Med. 2013 Dec 13;13:357. doi: 10.1186/1472-6882-13-357.