PainNCT01734876
Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease
A study testing Tactile Touch and Rest To Music in people with Pain and Sleep, run by Region Jönköping County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- What is being tested?
- Tactile Touch and Rest To Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson´s Disease
- chronic pain
Who cannot join
- Epilepsy
- Active malignancy
- Diabetes mellitus
- Parkinson´s disease in complication phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.
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.
Read the 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.
- Being tested
- Tactile Touch, Rest To Music
- Keywords
- Parkinson´s disease, Pain, Sleep, HPA axis function, Health Related Quality of Life
- Medical subject headings
- Pain, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile TouchBehavioural
Also called massage therapy
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 MusicBehavioural
Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Tactile Touch | Experimental | Tactile Touch is given to the active arm Receives: 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 Receives: Behavioral: Tactile Touch; Behavioral: Rest To Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 1 year
Secondary outcomes (1)
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)
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Sponsor
- Investigators
- Carl Jo Törnhage, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734876
- Sponsor's protocol ID
- D 03-673
- Other IDs
- FUTURUM 254481
- Status last verified
- Nov 2012
- First submitted
- 11 Nov 2012
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21887109Skogar 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.
PubMed 23091387Tornhage 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.
PubMed 24330473
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT01734876
- Acronym / sponsor ID
- D 03-673
- Keywords
- Parkinson´s disease, Pain, Sleep, HPA axis function, Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- University Hospital, Linkoeping
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tactile Touch | Experimental | Behavioral: Tactile Touch, Behavioral: Rest To MusicTactile Touch is given to the active arm |
| Rest To Music | Active comparator | Behavioral: Tactile Touch, Behavioral: Rest To MusicRest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson´s Disease
- chronic pain
Key exclusion criteria (4 listed)
- Epilepsy
- Active malignancy
- Diabetes mellitus
- Parkinson´s disease in complication phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile TouchAlso: massage therapyTactile 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. | Behavioural | Rest To Music, Tactile Touch |
| Rest To MusicParticipants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes. | Behavioural | Rest To Music, Tactile Touch |
Primary outcome
Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain
Time frame: Within 1 year
HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).
1 secondary outcome
Effect of Tactile Touch on HRQoL
Time frame: Within 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Results publication: PubMed 21887109Skogar 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.
- Results publication: PubMed 23091387Skogar 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.
- Derived from this study: PubMed 24330473Tornhage 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.
- Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of LifeLink provided by the sponsor.
- Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Jo Törnhage, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile Touch and Rest To Music in people with Pain and Sleep, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.