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Completed

NCT Number: NCT05378984

Cocoa Intake and Muscle Pain Sensation

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Dental Medicine

Huddinge, 141 04, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

before - hypertonic saline 5%

Other

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

after - hypertonic saline 5%

Other

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

Primary outcomes

  1. Change in pain intensity by intake of chocolate

    Time frame: 5 min after injection of hypertonic saline

    Pain intensity will be assssed using a 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)

  2. Change in peak pain intensity before and after intake of chocolate

    Time frame: 5 min after injection of hypertonic saline

    Peak pain intensity will be asessed from the 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)

  3. Change in pain duration by intake of chocolate

    Time frame: Pain duration up to 300 seconds after injection of hypertonic saline

    Pain duration is assessed in seconds.

  4. Change in pain area by intake of chocolate

    Time frame: Pain area is marked 5 min after injection of hypertonic saline

    Pain area will be marked on lateral charts of the head before and after intake of chocolate and measured in au.

Secondary outcomes

  1. Change in pressure pain threshold by intake of chocolate

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

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Cocoa Intake and Muscle Pain Sensation: an Experimental Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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