<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01734876</url>
  </required_header>
  <id_info>
    <org_study_id>D 03-673</org_study_id>
    <secondary_id>FUTURUM 254481</secondary_id>
    <nct_id>NCT01734876</nct_id>
  </id_info>
  <brief_title>Effects of Tactile Touch on Chronic Pain in Parkinson´s Disease</brief_title>
  <official_title>Short and Long-term Effects of Tactile Touch on Salivary Cortisol Concentrations in Parkinson's Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Jönköping County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Jönköping County</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality of&#xD;
      Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and&#xD;
      chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or only&#xD;
      Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10 weeks&#xD;
      was the intervention period , followed by a follow-up period. Outcome measures were salivary&#xD;
      cortisol concentration measured at seven occasions of which two were immediately before,&#xD;
      after and 30 minutes after intervention. Diurnal salivary cortisol was calculated based on&#xD;
      four timepoints of sampling per 24 hour period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was initiated by the massage therapists who had experienced pain reduction in&#xD;
      parkinsonian patients when usin Tactile Touch. As the method consisted of a combination of&#xD;
      Music Therapy and Aroma therapy we chose just to study the effects of the Tactile Touch.&#xD;
&#xD;
      HrQOL was measured using SF-36 (Swe.ver.1) sleep was measured with the PDSS scale, pain wit&#xD;
      VAS 10 cm scale and the Pain-O.Meter. All measures were repeated during the study period.&#xD;
&#xD;
      Patients were not allowed to change their basic antiparkinson medication.All drugs were&#xD;
      carefully registered and supervised by specialists in neurology at the three different study&#xD;
      sites in Southern Sweden. The massage technique was described in a 11 A4 pages long&#xD;
      description and the same method was used at all three sites. The same aroma oils, same&#xD;
      temperature in the rooms and the same music was used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2004</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">December 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain</measure>
    <time_frame>Within 1 year</time_frame>
    <description>HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Tactile Touch on HRQoL</measure>
    <time_frame>Within 1 year</time_frame>
    <description>As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Parkitouch Study</measure>
    <time_frame>Wihin 1 year</time_frame>
    <description>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?</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Pain</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Tactile Touch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tactile Touch is given to the active arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rest To Music</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tactile Touch</intervention_name>
    <description>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.</description>
    <arm_group_label>Rest To Music</arm_group_label>
    <arm_group_label>Tactile Touch</arm_group_label>
    <other_name>massage therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rest To Music</intervention_name>
    <description>Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.</description>
    <arm_group_label>Rest To Music</arm_group_label>
    <arm_group_label>Tactile Touch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson´s Disease&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Parkinson´s disease in complication phase&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl Jo Törnhage, MD, PhD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>FUTURUM</name>
      <address>
        <city>Jönköping</city>
        <zip>SE 551 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>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</url>
    <description>Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160865/</url>
    <description>Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations</description>
  </link>
  <results_reference>
    <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>
    <PMID>21887109</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>23091387</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson´s disease</keyword>
  <keyword>Pain</keyword>
  <keyword>Sleep</keyword>
  <keyword>HPA axis function</keyword>
  <keyword>Health Related Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734876
org study id: D 03-673
secondary id: FUTURUM 254481
nct id: NCT01734876
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Effect of Tactile Touch on Hypothalamo Pituitary Adrenal (HPA) axis function in Parkinson Disease with chronic pain
time frame: Within 1 year
description: HPA axis function in PD patients (salivary cortisol, mmol / l diurnal curve , pre and post intervention).
measure: Effect of Tactile Touch on HRQoL
time frame: Within 1 year
description: As secondary endpoints, HealthRelated Quality of Life (HRQoL),measured by SF-36,Swe ver.1 sleep quality measured by Parkinson Disease Sleep Scale (PDSS)
measure: The Parkitouch Study
time frame: Wihin 1 year
description: 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?
arm group label: Tactile Touch
arm group type: Experimental
description: Tactile Touch is given to the active arm
arm group label: Rest To Music
arm group type: Active Comparator
description: Rest to Music. Rest for 30-60 minutes, aroma therapy, quit music in the background, well temepered room, lying position
intervention type: Behavioral
intervention name: Tactile Touch
description: 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.
arm group label: Rest To Music
arm group label: Tactile Touch
other name: massage therapy
intervention type: Behavioral
intervention name: Rest To Music
description: Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
arm group label: Rest To Music
arm group label: Tactile Touch
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carl Jo Törnhage, MD, PhD
role: Principal Investigator
facility: 
country: Sweden
url: 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
description: Parkinson's disease patients' subjective descriptions of characteristics of chronic pain, sleeping patterns and Health Related Quality of Life
url: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160865/
description: Diurnal salivary cortisol concentrations in Parkinson's disease: increased total secretion and morning cortisol concentrations
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.
PMID: 21887109
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.
PMID: 23091387
responsible party type: Sponsor
mesh term: Parkinson Disease