Cocoa Intake and Muscle Pain Sensation

NCT05378984 | Completed

• 1 other identifier: CHIMPS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Pain

Keywords

Myalgia; Experimental pain; Human; Temporomandibular disorders; Cocoa

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in pressure pain threshold by intake of chocolate

  Pressure pain thresholds are assessed 5 min after injection of hypertonic saline

Study Arms (3)

Dark Chocolate

ACTIVE COMPARATOR

Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5%

Milk Chocolate

ACTIVE COMPARATOR

Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5%

White Chocolate

ACTIVE COMPARATOR

Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5%

Interventions

before - hypertonic saline 5% OTHER

pain was induced by intramuscular injections of hypertonic saline (5%)

Dark Chocolate; Milk Chocolate; White Chocolate

after - hypertonic saline 5% OTHER

pain was induced by intramuscular injections of hypertonic saline (5%)

Dark Chocolate; Milk Chocolate; White Chocolate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good general health
• age between 18-40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Department of Dental Medicine

Huddinge, 141 04, Sweden

Location

Related Publications (1)

• Hajati A, Brondani M, Angerstig L, Klein V, Liljeblad L, Al-Moraissi EA, Louca Jounger S, Brondani B, Christidis N. Chocolate intake and muscle pain sensation: A randomized experimental study. PLoS One. 2023 May 24;18(5):e0284769. doi: 10.1371/journal.pone.0284769. eCollection 2023.

  PMID: 37224109 DERIVED

MeSH Terms

Conditions

Myalgia; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, senior lecturer, senior consultant

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: March 1, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication and up to 20 years after publication
• Access Criteria: Data will be shared with other researchers upon request from any of the authors

Locations

SE (1)