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

NCT ID: NCT01734876

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Pain; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tactile Touch

Tactile Touch is given to the active arm

Group Type: EXPERIMENTAL

Tactile Touch

Intervention Type: 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.

Rest To Music

Intervention Type: BEHAVIORAL

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

Rest To Music

Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position

Group Type: ACTIVE_COMPARATOR

Tactile Touch

Intervention Type: 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.

Rest To Music

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Rest To Music

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

Intervention Type: BEHAVIORAL

Other Intervention Names

massage therapy

Eligibility Criteria

Inclusion Criteria

• Parkinson´s Disease
• chronic pain

Exclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Region Jönköping County

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Jo Törnhage, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

FUTURUM

Jönköping, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 21887109 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23091387 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24330473 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed?term=Parkinson%E2%80%99s%20disease%20patients%E2%80%99%20subjective%20descriptions%20of%20characteristics%20of%20chronic%20pain%2C%20sleeping%20patterns%20and%20Health%20Related%20Quality%20of%20Life

Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160865/

Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations

Other Identifiers

FUTURUM 254481

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D 03-673

Identifier Type: -

Identifier Source: org_study_id