Muscle PainNCT05378984
Cocoa Intake and Muscle Pain Sensation
A study testing before - hypertonic saline 5% and after - hypertonic saline 5% in people with Muscle Pain, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Pain
- What is being tested?
- before - hypertonic saline 5% and after - hypertonic saline 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health
- age between 18-40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Dental Medicine
Huddinge, 141 04
About this study
Official title: 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.
- Conditions
- Muscle Pain
- Being tested
- before - hypertonic saline 5%, after - hypertonic saline 5%
- Keywords
- Myalgia, Experimental pain, Human, Temporomandibular disorders, Cocoa
- Medical subject headings
- Myalgia, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%)
| Study group | Role | What they receive |
|---|---|---|
| Dark Chocolate | Active comparator | Not described Receives: Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5% |
| Milk Chocolate | Active comparator | Not described Receives: Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5% |
| White Chocolate | Active comparator | Not described Receives: Other: before - hypertonic saline 5%; Other: after - hypertonic saline 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 5 min after injection of hypertonic saline
Change in pain duration by intake of chocolate
Pain duration is assessed in seconds.
Measured: 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.
Measured: 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 using a digital algometer over the area of injection in the masseter muscle with a pressure rate of 30kPa/s.
Measured: Pressure pain thresholds are assessed 5 min after injection of hypertonic saline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Mar 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Christidis, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378984
- Sponsor's protocol ID
- CHIMPS
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers upon request from any of the authors
Publications
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.
PubMed 37224109
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocoa Intake and Muscle Pain Sensation: an Experimental Study
- ClinicalTrials.gov ID
- NCT05378984
- Acronym / sponsor ID
- CHIMPS
- Conditions
- Muscle Pain
- Keywords
- Myalgia, Experimental pain, Human, Temporomandibular disorders, Cocoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good general health
- age between 18-40 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| before - hypertonic saline 5%pain was induced by intramuscular injections of hypertonic saline (5%) | Other | Dark Chocolate, Milk Chocolate, White Chocolate |
| after - hypertonic saline 5%pain was induced by intramuscular injections of hypertonic saline (5%) | Other | Dark Chocolate, Milk Chocolate, White Chocolate |
Primary outcome
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)
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)
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.
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.
1 secondary outcome
Change in pressure pain threshold by intake of chocolate
Time frame: Pressure pain thresholds are assessed 5 min after injection of hypertonic saline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 37224109Hajati 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.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers upon request from any of the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing before - hypertonic saline 5% and after - hypertonic saline 5% in people with Muscle Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity by intake of chocolate (time frame: 5 min after injection of hypertonic saline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.