Cocoa Intake and Muscle Pain Sensation

Not Applicable

Completed

• Conditions: Muscle Pain
• Interventions: Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5%

• Registration Number: NCT05378984
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Milk Chocolate	before - hypertonic saline 5%	-
Dark Chocolate	before - hypertonic saline 5%	-
White Chocolate	before - hypertonic saline 5%	-
Dark Chocolate	after - hypertonic saline 5%	-
Milk Chocolate	after - hypertonic saline 5%	-
White Chocolate	after - hypertonic saline 5%	-

Primary Outcome Measures

Name	Time	Method
Change in pain intensity by intake of chocolate	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)
Change in peak pain intensity before and after intake of chocolate	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)
Change in pain duration by intake of chocolate	Pain duration up to 300 seconds after injection of hypertonic saline	Pain duration is assessed in seconds.
Change in pain area by intake of chocolate	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 Outcome Measures

Name	Time	Method
Change in pressure pain threshold by intake of chocolate	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.

Trial Locations

Locations (1)

Karolinska Institutet, Department of Dental Medicine; 🇸🇪 Huddinge, Sweden