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

NCT01734876 | Completed DMC

• 2 other identifiers: D 03-673FUTURUM 254481
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Sleep

Keywords

Parkinson´s disease; Pain; Sleep; HPA axis function; Health Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of Tactile Touch on HRQoL

  Within 1 year

Other Outcomes (1)

• The Parkitouch Study

  Wihin 1 year

Study Arms (2)

Tactile Touch

EXPERIMENTAL

Tactile Touch is given to the active arm

Behavioral: Tactile Touch; Behavioral: Rest To Music

Rest To Music

ACTIVE COMPARATOR

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

Behavioral: Tactile Touch; Behavioral: Rest To Music

Interventions

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.

Also known as: massage therapy

Rest To Music; Tactile Touch

Rest To Music BEHAVIORAL

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

Rest To Music; Tactile Touch

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson´s Disease
• chronic pain

You may not qualify if:

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

Sponsors & Collaborators

• Region Jönköping County: lead
• University Hospital, Linkoeping: collaborator

Study Sites (1)

FUTURUM

Jönköping, SE 551 85, Sweden

Location

Related Publications (3)

• 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.

  PMID: 21887109 RESULT

• 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.

  PMID: 23091387 RESULT

• 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.

  PMID: 24330473 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain; Parkinson Disease

Interventions

Touch; Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Carl Jo Törnhage, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2012
• First Posted: November 28, 2012
• Study Start: September 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: October 8, 2020

Record last verified: 2012-11

Locations

SE (1)