PainNCT02577770
The Effect of Caffeine on Acupuncture Analgesia With the Human Pain Model
A study testing acupuncture, 200mg caffeine and 400mg caffeine in people with Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is a single center, double blind, randomized, parallel-group study to assess the effect of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human pain model. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- acupuncture, 200mg caffeine and 400mg caffeine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2019
- 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
- Age of a subject is between 18 and 40 years old, male or female
- No known active ongoing disease, in good general health, with a BMI ranging from 18 to 30 kg/m2
- No history of mental disorders,infectious diseases and bleeding disorders. No history of allergic reaction. Females who are not pregnant, lactating, of child-bearing potential, or have no a pregnancy plan within 3 months
- No smoking, drinking alcohol
- No intake of beverage, food and alcohol ,which contains caffeine at least two hours
- No use of any of the methyl purine drugs. No use of any of the drugs ,which can affect the half-life of caffeine, such as: cimetidine, steroids, growth hormone, etc
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- No previous experience with acupuncture or other related treatments within 3 days
- Reliable, cooperative, and of adequate intelligence to record the requested information on the questionnaire form
- Informed consent form must be signed by subjects
Who cannot join
- Subject with serious blood, heart, liver, kidney disease, digestive, or hematopoietic system disease
- Subject with serious mental disorders, infectious diseases and bleeding disorders. Subject has a history of allergic reaction. Females who are pregnant, lactating, of child-bearing potential, or have a pregnancy plan within 3 months;
- Prior use of any type of analgesic drugs before study within 5 half-lives of the drugs
- Use of any of the methyl purine drugs. Use of any of the drugs, which can affect the half-life of caffeine, such as: Sympathomimetic drugs, theophylline drugs , α or β-blockers drugs, and any antihypertensive drugs, etc
- Ingestion of any caffeine-containing beverage, food or alcohol 6 hours or less before study
- Subject has a previous experience with acupuncture or other related treatments within 7 days
- Suffered from medical or psychiatric disorders that prevented them from participating in the study
- Subject who belongs to acupuncture-phobia
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: A Single Center, Double Blind, Randomized, Parallel-group Study to Assess the Effect of 200mg Caffeine,400mg Caffeine and Decaffeinated on Acupuncture Analgesia With the Human Pain Model
This is a single center, double blind, randomized, parallel-group study to assess the effect of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human pain model.
Read the detailed description
Aim: To evaluate the effect of caffeine on acupuncture analgesia with the human pain model.
Design: Double blind, randomized controlled trial will be performed in Chengdu. The study including two pain models : Potassium pain model and Capsaicin pain model. Both models including the following several groups: 200mg caffeine group, 400mg caffeine group, and decaffeinated group. Participants will be randomly assign to the three groups. Each participants will receive coffee drinking and acupuncture intervention. Each subjects of the Potassium pain model will receive be measured the pain at baseline, 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at baseline, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Each subjects of the capsaicin pain model will be measured the spontaneous pain with VAS scale and the area of hyperalgesia with Von Frey hair at the time of 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at the time of 5 minutes after topical application of capsaicin, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
- Conditions
- Pain
- Being tested
- acupuncture, 200mg caffeine, 400mg caffeine, Decaffeinated
- Keywords
- Acupuncture, caffeine, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
therapeutic acupuncture treatment with actual needles
200mg caffeineDietary supplement
8g coffee, po
400mg caffeineDietary supplement
16g coffee, po
DecaffeinatedDietary supplement
decaffeinated coffee, po
| Study group | Role | What they receive |
|---|---|---|
| 200mg caffeine plus acupuncture | Experimental | In healthy subjects Receives: Device: acupuncture; Dietary Supplement: 200mg caffeine |
| 400mg caffeine plus acupuncture | Experimental | In healthy subjects Receives: Device: acupuncture; Dietary Supplement: 400mg caffeine |
| Decaffeinated plus acupuncture | Placebo comparator | In healthy subjects Receives: Device: acupuncture; Dietary Supplement: Decaffeinated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain threshold will be measured with Potassium Pain Tester for potassium pain
Measured: Baseline, 30 minutes after drinking coffee,10,20,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed
Change of pain will be measured with Visual Analog Scale for capsaicin pain
Measured: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Change of pain will be measured with Von Frey Hair for capsaicin pain
Measured: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Secondary outcomes (2)
The concentration of caffeine in plasma measured by high performance liquid chromatography in both models
Measured: one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
The concentration of adenosine in plasma measured by high performance liquid
Measured: one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Boston University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577770
- Sponsor's protocol ID
- 2014TD0018
- Status last verified
- Feb 2020
- First submitted
- 12 Sep 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double Blind, Randomized, Parallel-group Study to Assess the Effect of 200mg Caffeine,400mg Caffeine and Decaffeinated on Acupuncture Analgesia With the Human Pain Model
- ClinicalTrials.gov ID
- NCT02577770
- Acronym / sponsor ID
- 2014TD0018
- Conditions
- Pain
- Keywords
- Acupuncture, caffeine, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- University of Leipzig, Boston University
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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 is a single center, double blind, randomized, parallel-group study to assess the effect of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human pain model.
Detailed description
Aim: To evaluate the effect of caffeine on acupuncture analgesia with the human pain model.
Design: Double blind, randomized controlled trial will be performed in Chengdu. The study including two pain models : Potassium pain model and Capsaicin pain model. Both models including the following several groups: 200mg caffeine group, 400mg caffeine group, and decaffeinated group. Participants will be randomly assign to the three groups. Each participants will receive coffee drinking and acupuncture intervention. Each subjects of the Potassium pain model will receive be measured the pain at baseline, 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at baseline, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Each subjects of the capsaicin pain model will be measured the spontaneous pain with VAS scale and the area of hyperalgesia with Von Frey hair at the time of 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at the time of 5 minutes after topical application of capsaicin, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg caffeine plus acupuncture | Experimental | Device: acupuncture, Dietary Supplement: 200mg caffeineIn healthy subjects |
| 400mg caffeine plus acupuncture | Experimental | Device: acupuncture, Dietary Supplement: 400mg caffeineIn healthy subjects |
| Decaffeinated plus acupuncture | Placebo comparator | Device: acupuncture, Dietary Supplement: DecaffeinatedIn healthy subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age of a subject is between 18 and 40 years old, male or female
- No known active ongoing disease, in good general health, with a BMI ranging from 18 to 30 kg/m2
- No history of mental disorders,infectious diseases and bleeding disorders. No history of allergic reaction. Females who are not pregnant, lactating, of child-bearing potential, or have no a pregnancy plan within 3 months
- No smoking, drinking alcohol
- No intake of beverage, food and alcohol ,which contains caffeine at least two hours
Key exclusion criteria (8 listed)
- Subject with serious blood, heart, liver, kidney disease, digestive, or hematopoietic system disease
- Subject with serious mental disorders, infectious diseases and bleeding disorders. Subject has a history of allergic reaction. Females who are pregnant, lactating, of child-bearing potential, or have a pregnancy plan within 3 months;
- Prior use of any type of analgesic drugs before study within 5 half-lives of the drugs
- Use of any of the methyl purine drugs. Use of any of the drugs, which can affect the half-life of caffeine, such as: Sympathomimetic drugs, theophylline drugs , α or β-blockers drugs, and any antihypertensive drugs, etc
- Ingestion of any caffeine-containing beverage, food or alcohol 6 hours or less before study
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 |
|---|---|---|
| acupuncturetherapeutic acupuncture treatment with actual needles | Device | 200mg caffeine plus acupuncture, 400mg caffeine plus acupuncture, Decaffeinated plus acupuncture |
| 200mg caffeine8g coffee, po | Dietary supplement | 200mg caffeine plus acupuncture |
| 400mg caffeine16g coffee, po | Dietary supplement | 400mg caffeine plus acupuncture |
| Decaffeinateddecaffeinated coffee, po | Dietary supplement | Decaffeinated plus acupuncture |
Primary outcome
Change of pain threshold will be measured with Potassium Pain Tester for potassium pain
Time frame: Baseline, 30 minutes after drinking coffee,10,20,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed
Change of pain will be measured with Visual Analog Scale for capsaicin pain
Time frame: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Change of pain will be measured with Von Frey Hair for capsaicin pain
Time frame: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
2 secondary outcomes
The concentration of caffeine in plasma measured by high performance liquid chromatography in both models
Time frame: one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
The concentration of adenosine in plasma measured by high performance liquid
Time frame: one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
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 17 Feb 2020.
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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 acupuncture, 200mg caffeine and 400mg caffeine in people with Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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 9 inclusion and 8 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 17 Feb 2020. 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 China. 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. Some participants in this study may receive a placebo. 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 of pain threshold will be measured with Potassium Pain Tester for potassium pain (time frame: Baseline, 30 minutes after drinking coffee,10,20,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2020.