Cocoa Intake and Muscle Pain Sensation

Muscle Pain Clinical Trial

Official title:

Cocoa Intake and Muscle Pain Sensation: an Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378984
• Other study ID #: CHIMPS
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: May 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Pain
• Myalgia

Intervention

Other:
• before - hypertonic saline 5%
pain was induced by intramuscular injections of hypertonic saline (5%)
• after - hypertonic saline 5%
pain was induced by intramuscular injections of hypertonic saline (5%)

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Dental Medicine	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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