HealthyNCT02377180
Capsaicin-induced Muscle Pain in Humans
A study testing Intramuscular capsaicin injection, Suprascapular nerve block and Local anesthetic infiltration in people with Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
There is currently no specific diagnostic test for primary muscular pain. The present study investigates whether selective blockade of the suprascapular nerve can effectively abolish experimental pain arising from the supraspinatus muscle. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intramuscular capsaicin injection, Suprascapular nerve block and Local anesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Dec 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Written informed consent
Who cannot join
- Any acute pain at the moment of testing
- Intake of analgesics 24hours before testing
- Intake of antidepressants, anticonvulsants or benzodiazepines
- Allergy to local anesthetic or skin disinfectant
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Department of Anesthesiology and Pain Therapy,Inselspital Bern
Bern, Canton of Bern, 3010
About this study
Official title: Capsaicin-induced Muscle Pain in Humans: From Investigating Central Pain Processing to Developing Clinical Applications
There is currently no specific diagnostic test for primary muscular pain. The present study investigates whether selective blockade of the suprascapular nerve can effectively abolish experimental pain arising from the supraspinatus muscle. Experimental muscle pain is induced by intramuscular injection of capsaicin, an alkaloid from red chili peppers. The study consists of three parts:
- to describe the development, time course and intensity of capsaicin-induced muscle pain
- to evaluate the effectiveness of suprascapular nerve block against capsaicin-induced muscle pain
- to compare suprascapular nerve block and direct intramuscular local anesthetic infiltration for their effectiveness in capsaicin-induced muscle pain
Read the detailed description
Background
Musculoskeletal pain is one of the most common reasons for consulting a physician. Many musculoskeletal pain disorders are associated with a widespread decrease in pain thresholds, indicating a state of hyperexcitability of the central nervous system.
This central hypersensitivity can be assessed by measuring pain thresholds to different experimental stimuli, using so-called quantitative sensory tests (QST).
Several experimental pain models are being used in healthy volunteers in order to study the central mechanisms of pain processing. Injection of capsaicin is one of them, which is associated with spreading of local pain, development of referred pain and hyperalgesia to thermal, mechanical or electrical stimuli.
Intramuscular injection of capsaicin is therefore potentially interesting for investigating primary muscle pain, central hypersensitivity and endogenous pain modulation. The present research project comprises three substudies which use intramuscular capsaicin to detect changes in central pain processing and to evaluate clinical tools for the diagnosis of primary muscle pain.
Part 1: The investigators hypothesize that the intensity, duration and expansion area of capsaicin-induced muscle pain depends on a subject's endogenous pain modulation. The investigators expect that subjects with strong endogenous pain modulation develop less pain and hyperalgesia after capsaicin injection than subjects with poor endogenous pain modulation. A large sample of healthy volunteers will therefore be screened using QST and then recruited for capsaicin injection if they show either very strong or very weak endogenous pain modulation. The data of the whole sample can be used to determine normative values of endogenous pain modulation.
Part 2 investigates the ability of suprascapular nerve block to abolish primary muscle pain. Healthy volunteers will receive capsaicin injection into the supraspinatus muscle or the trapezius muscle as a control condition in a randomized, blinded fashion. The investigators expect that the nerve block is more effective in the former compared to the latter muscle.
Part 3 compares the analgesic efficacy of suprascapular nerve block and direct intramuscular local anesthetic infiltration of the supraspinatus muscle after capsaicin injection. This will determine which procedure is more effective to treat primary muscle pain.
Objective
- To determine normative values for endogenous pain modulation in healthy volunteers
- To demonstrate that capsaicin-induced pain and hyperalgesia depend on endogenous pain modulation
- To calculate sensitivity and specificity of suprascapular nerve block for the diagnosis of primary muscle pain
- To determine whether suprascapular nerve block or intramuscular local anesthetic infiltration are more effective against muscle pain
Methods
- intramuscular injection of capsaicin
- quantitative sensory tests (pressure pain thresholds)
- ultrasound-guided suprascapular nerve block
- ultrasound-guided intramuscular local anesthetic infiltration
- Conditions
- Healthy
- Being tested
- Intramuscular capsaicin injection, Suprascapular nerve block, Local anesthetic infiltration
- Keywords
- musculoskeletal pain, regional anesthesia, diagnostic nerve block, intramuscular capsaicin, referred pain, hyperalgesia, experimental pain, central hypersensitivity, human experimental pain
- Medical subject headings
- Musculoskeletal Pain, Pain, Referred, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular capsaicin injectionProcedure or surgery
Intramuscular injection of capsaicin: 50 mcg/0.5 ml
Suprascapular nerve blockProcedure or surgery
Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus or trapezius muscle in randomized order, followed by suprascapular nerve block (ultrasound-guided) using Lidocaine 1%; nerve block is expected to be effective only in pain arising from the supraspinatus muscle. Trapezius pain serves as control condition.
Evaluates the diagnostic validity of suprascapular nerve block for muscle pain.
Local anesthetic infiltrationProcedure or surgery
Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus muscle in two different sessions; suprascapular nerve block in one session and intramuscular local anesthetic infiltration in one session (in randomized order) using Lidocaine 1%; the aim is to investigate which procedure provides faster and more efficient pain relief. Compares effectivity of suprascapular nerve block vs. intramuscular local anesthetic infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Intramuscular injection of capsaicin for the study of pain and hyperalgesia Receives: Procedure: Intramuscular capsaicin injection |
| Part 2 | Active comparator | Pain arising from supraspinatus muscle vs. pain arising from trapezius muscle. Nerve block is only expected to be effective in the former. Receives: Procedure: Suprascapular nerve block |
| Part 3 | Active comparator | Suprascapular nerve block vs. intramuscular local anesthetic against pain arising from the supraspinatus muscle. Receives: Procedure: Local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of shoulder pain on numeric rating scale
Measured: two hours
Secondary outcomes (2)
Pressure pain thresholds
Measured: two hours
Area of referred pain
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Michele Curatolo, M.D., Ph.D., Study chair, Department of Anesthesiology and Pain Therapy, University of Washington, Seattle WA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377180
- Sponsor's protocol ID
- 066/13
- Status last verified
- Jan 2017
- First submitted
- 11 Feb 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Graven-Nielsen T, Gibson SJ, Laursen RJ, Svensson P, Arendt-Nielsen L. Opioid-insensitive hypoalgesia to mechanical stimuli at sites ipsilateral and contralateral to experimental muscle pain in human volunteers. Exp Brain Res. 2002 Sep;146(2):213-22. doi: 10.1007/s00221-002-1169-7. Epub 2002 Jul 13.
PubMed 12195523Witting N, Svensson P, Gottrup H, Arendt-Nielsen L, Jensen TS. Intramuscular and intradermal injection of capsaicin: a comparison of local and referred pain. Pain. 2000 Feb;84(2-3):407-12. doi: 10.1016/s0304-3959(99)00231-6.
PubMed 10666547Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168.
PubMed 22222688
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin-induced Muscle Pain in Humans: From Investigating Central Pain Processing to Developing Clinical Applications
- ClinicalTrials.gov ID
- NCT02377180
- Acronym / sponsor ID
- 066/13
- Conditions
- Healthy
- Keywords
- musculoskeletal pain, regional anesthesia, diagnostic nerve block, intramuscular capsaicin, referred pain, hyperalgesia, experimental pain, central hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Mar 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.
There is currently no specific diagnostic test for primary muscular pain. The present study investigates whether selective blockade of the suprascapular nerve can effectively abolish experimental pain arising from the supraspinatus muscle. Experimental muscle pain is induced by intramuscular injection of capsaicin, an alkaloid from red chili peppers. The study consists of three parts:
- to describe the development, time course and intensity of capsaicin-induced muscle pain
- to evaluate the effectiveness of suprascapular nerve block against capsaicin-induced muscle pain
- to compare suprascapular nerve block and direct intramuscular local anesthetic infiltration for their effectiveness in capsaicin-induced muscle pain
Detailed description
Background
Musculoskeletal pain is one of the most common reasons for consulting a physician. Many musculoskeletal pain disorders are associated with a widespread decrease in pain thresholds, indicating a state of hyperexcitability of the central nervous system.
This central hypersensitivity can be assessed by measuring pain thresholds to different experimental stimuli, using so-called quantitative sensory tests (QST).
Several experimental pain models are being used in healthy volunteers in order to study the central mechanisms of pain processing. Injection of capsaicin is one of them, which is associated with spreading of local pain, development of referred pain and hyperalgesia to thermal, mechanical or electrical stimuli.
Intramuscular injection of capsaicin is therefore potentially interesting for investigating primary muscle pain, central hypersensitivity and endogenous pain modulation. The present research project comprises three substudies which use intramuscular capsaicin to detect changes in central pain processing and to evaluate clinical tools for the diagnosis of primary muscle pain.
Part 1: The investigators hypothesize that the intensity, duration and expansion area of capsaicin-induced muscle pain depends on a subject's endogenous pain modulation. The investigators expect that subjects with strong endogenous pain modulation develop less pain and hyperalgesia after capsaicin injection than subjects with poor endogenous pain modulation. A large sample of healthy volunteers will therefore be screened using QST and then recruited for capsaicin injection if they show either very strong or very weak endogenous pain modulation. The data of the whole sample can be used to determine normative values of endogenous pain modulation.
Part 2 investigates the ability of suprascapular nerve block to abolish primary muscle pain. Healthy volunteers will receive capsaicin injection into the supraspinatus muscle or the trapezius muscle as a control condition in a randomized, blinded fashion. The investigators expect that the nerve block is more effective in the former compared to the latter muscle.
Part 3 compares the analgesic efficacy of suprascapular nerve block and direct intramuscular local anesthetic infiltration of the supraspinatus muscle after capsaicin injection. This will determine which procedure is more effective to treat primary muscle pain.
Objective
- To determine normative values for endogenous pain modulation in healthy volunteers
- To demonstrate that capsaicin-induced pain and hyperalgesia depend on endogenous pain modulation
- To calculate sensitivity and specificity of suprascapular nerve block for the diagnosis of primary muscle pain
- To determine whether suprascapular nerve block or intramuscular local anesthetic infiltration are more effective against muscle pain
Methods
- intramuscular injection of capsaicin
- quantitative sensory tests (pressure pain thresholds)
- ultrasound-guided suprascapular nerve block
- ultrasound-guided intramuscular local anesthetic infiltration
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Procedure: Intramuscular capsaicin injectionIntramuscular injection of capsaicin for the study of pain and hyperalgesia |
| Part 2 | Active comparator | Procedure: Suprascapular nerve blockPain arising from supraspinatus muscle vs. pain arising from trapezius muscle. Nerve block is only expected to be effective in the former. |
| Part 3 | Active comparator | Procedure: Local anesthetic infiltrationSuprascapular nerve block vs. intramuscular local anesthetic against pain arising from the supraspinatus muscle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Written informed consent
Key exclusion criteria (5 listed)
- Any acute pain at the moment of testing
- Intake of analgesics 24hours before testing
- Intake of antidepressants, anticonvulsants or benzodiazepines
- Allergy to local anesthetic or skin disinfectant
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Intramuscular capsaicin injectionIntramuscular injection of capsaicin: 50 mcg/0.5 ml | Procedure or surgery | Part 1 |
| Suprascapular nerve blockInjection of capsaicin 50 mcg/0.5 ml into the supraspinatus or trapezius muscle in randomized order, followed by suprascapular nerve block (ultrasound-guided) using Lidocaine 1%; nerve block is expected to be effective only in pain arising from the supraspinatus muscle. Trapezius pain serves as control condition. Evaluates the diagnostic validity of suprascapular nerve block for muscle pain. | Procedure or surgery | Part 2 |
| Local anesthetic infiltrationInjection of capsaicin 50 mcg/0.5 ml into the supraspinatus muscle in two different sessions; suprascapular nerve block in one session and intramuscular local anesthetic infiltration in one session (in randomized order) using Lidocaine 1%; the aim is to investigate which procedure provides faster and more efficient pain relief. Compares effectivity of suprascapular nerve block vs. intramuscular local anesthetic infiltration. | Procedure or surgery | Part 3 |
Primary outcome
Intensity of shoulder pain on numeric rating scale
Time frame: two hours
2 secondary outcomes
Pressure pain thresholds
Time frame: two hours
Area of referred pain
Time frame: two hours
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 18 Jan 2017.
- Background: PubMed 12195523Graven-Nielsen T, Gibson SJ, Laursen RJ, Svensson P, Arendt-Nielsen L. Opioid-insensitive hypoalgesia to mechanical stimuli at sites ipsilateral and contralateral to experimental muscle pain in human volunteers. Exp Brain Res. 2002 Sep;146(2):213-22. doi: 10.1007/s00221-002-1169-7. Epub 2002 Jul 13.
- Background: PubMed 10666547Witting N, Svensson P, Gottrup H, Arendt-Nielsen L, Jensen TS. Intramuscular and intradermal injection of capsaicin: a comparison of local and referred pain. Pain. 2000 Feb;84(2-3):407-12. doi: 10.1016/s0304-3959(99)00231-6.
- Background: PubMed 22222688Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Michele Curatolo, M.D., Ph.D. study chair
Department of Anesthesiology and Pain Therapy, University of Washington, Seattle WA, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular capsaicin injection, Suprascapular nerve block and Local anesthetic infiltration in people with Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 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 18 Jan 2017. 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 Switzerland. 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?
Intensity of shoulder pain on numeric rating scale (time frame: two hours). 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 NCT02377180, which also lists 3 linked publications.
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 18 Jan 2017.