Cocoa Intake and Muscle Pain Sensation
Primary Purpose
Muscle Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
before - hypertonic saline 5%
after - hypertonic saline 5%
Sponsored by
About this trial
This is an interventional other trial for Muscle Pain focused on measuring Myalgia, Experimental pain, Human, Temporomandibular disorders, Cocoa
Eligibility Criteria
Inclusion Criteria:
- good general health
- age between 18-40 years
Exclusion Criteria:
- any pain-related diagnosis of TMD or of the orofacial region
- any headaches
- a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
- whiplash-associated disorders
- neurological disorders
- psychiatric disorders
- any allergy to the substances used
Sites / Locations
- Karolinska Institutet, Department of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dark Chocolate
Milk Chocolate
White Chocolate
Arm Description
Outcomes
Primary Outcome Measures
Change in pain intensity by intake of chocolate
Pain intensity will be assssed using a 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Change in peak pain intensity before and after intake of chocolate
Peak pain intensity will be asessed from the 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Change in pain duration by intake of chocolate
Pain duration is assessed in seconds.
Change in pain area by intake of chocolate
Pain area will be marked on lateral charts of the head before and after intake of chocolate and measured in au.
Secondary Outcome Measures
Change in pressure pain threshold by intake of chocolate
Pressure pain thresholds are assessed using a digital algometer over the area of injection in the masseter muscle with a pressure rate of 30kPa/s.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05378984
Brief Title
Cocoa Intake and Muscle Pain Sensation
Official Title
Cocoa Intake and Muscle Pain Sensation: an Experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This experimental randomized, double-blind, and controlled study included fifteen young, healthy, and pain-free men and 15 age-matched women.
It lasted for three visits with at least one-week washout. Pain was experimentally induced, twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before and after intake of one of the different chocolate-types; white (30% cocoa-content), milk (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and pressure pain threshold were assessed every fifth minute after each injection, between the time-points 5 to 30 min.
Prior to inclusion, all participants underwent an examination in a dental chair. This included a clinical examination of the orofacial region according to the Diagnostic Criteria for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also examined regarding their psychosocial status prior to inclusion, this included depression, somatization, anxiety, pain catastrophizing and stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Pain
Keywords
Myalgia, Experimental pain, Human, Temporomandibular disorders, Cocoa
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The chocolate given to the participant was of a different concentration of cocoa, distributed in a randomized and double-blinded order. The participants where given the chocolate with their eyes closed. A non-blinded examiner fed the chocolate to the participant at each clinical trial, while a blinded examiner did the assessments. The different types of chocolates were given at three different visits to all participants with at least one week of washout in between. To randomize the order in which the chocolates were given to each participant, an internet-based site was used (www.randomization.com; Seed 19525). The randomization was done in five blocks of six participants each, by a researcher who did not participate in the data collection
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dark Chocolate
Arm Type
Active Comparator
Arm Title
Milk Chocolate
Arm Type
Active Comparator
Arm Title
White Chocolate
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
before - hypertonic saline 5%
Intervention Description
pain was induced by intramuscular injections of hypertonic saline (5%)
Intervention Type
Other
Intervention Name(s)
after - hypertonic saline 5%
Intervention Description
pain was induced by intramuscular injections of hypertonic saline (5%)
Primary Outcome Measure Information:
Title
Change in pain intensity by intake of chocolate
Description
Pain intensity will be assssed using a 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Time Frame
5 min after injection of hypertonic saline
Title
Change in peak pain intensity before and after intake of chocolate
Description
Peak pain intensity will be asessed from the 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Time Frame
5 min after injection of hypertonic saline
Title
Change in pain duration by intake of chocolate
Description
Pain duration is assessed in seconds.
Time Frame
Pain duration up to 300 seconds after injection of hypertonic saline
Title
Change in pain area by intake of chocolate
Description
Pain area will be marked on lateral charts of the head before and after intake of chocolate and measured in au.
Time Frame
Pain area is marked 5 min after injection of hypertonic saline
Secondary Outcome Measure Information:
Title
Change in pressure pain threshold by intake of chocolate
Description
Pressure pain thresholds are assessed using a digital algometer over the area of injection in the masseter muscle with a pressure rate of 30kPa/s.
Time Frame
Pressure pain thresholds are assessed 5 min after injection of hypertonic saline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good general health
age between 18-40 years
Exclusion Criteria:
any pain-related diagnosis of TMD or of the orofacial region
any headaches
a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
whiplash-associated disorders
neurological disorders
psychiatric disorders
any allergy to the substances used
Facility Information:
Facility Name
Karolinska Institutet, Department of Dental Medicine
City
Huddinge
ZIP/Postal Code
141 04
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with other researchers upon request from any of the authors
IPD Sharing Time Frame
After publication and up to 20 years after publication
IPD Sharing Access Criteria
Data will be shared with other researchers upon request from any of the authors
Learn more about this trial
Cocoa Intake and Muscle Pain Sensation
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