Cocoa Intake and Muscle Pain Sensation

Cocoa Intake and Muscle Pain Sensation: an Experimental Study

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.

Study Overview

• Status: Completed
• Conditions: Muscle Pain
• Intervention / Treatment: Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5%

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 04
    • Karolinska Institutet, Department of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. good general health
2. age between 18-40 years

Exclusion Criteria:

1. any pain-related diagnosis of TMD or of the orofacial region
2. any headaches
3. a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
4. whiplash-associated disorders
5. neurological disorders
6. psychiatric disorders
7. any allergy to the substances used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dark Chocolate	Other: before - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%); Other: after - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%)
ACTIVE_COMPARATOR: Milk Chocolate	Other: before - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%); Other: after - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%)
ACTIVE_COMPARATOR: White Chocolate	Other: before - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%); Other: after - hypertonic saline 5%; pain was induced by intramuscular injections of hypertonic saline (5%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 min after injection of hypertonic saline
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)	5 min after injection of hypertonic saline
Change in pain duration by intake of chocolate	Pain duration is assessed in seconds.	Pain duration up to 300 seconds after injection of hypertonic saline
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.	Pain area is marked 5 min after injection of hypertonic saline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pressure pain thresholds are assessed 5 min after injection of hypertonic saline

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): December 20, 2020

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (ACTUAL): May 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Human; Cocoa; Myalgia; Experimental pain; Temporomandibular disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: CHIMPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No