Capsaicin-induced Muscle Pain in Humans
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Intramuscular capsaicin injection
Suprascapular nerve block
Local anesthetic infiltration
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring musculoskeletal pain, regional anesthesia, diagnostic nerve block, intramuscular capsaicin, referred pain, hyperalgesia, experimental pain, central hypersensitivity, human experimental pain
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 years
- Written informed consent
Exclusion Criteria
- 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
Sites / Locations
- University Department of Anesthesiology and Pain Therapy,Inselspital Bern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Part 1
Part 2
Part 3
Arm Description
Intramuscular injection of capsaicin for the study of pain and hyperalgesia
Pain arising from supraspinatus muscle vs. pain arising from trapezius muscle. Nerve block is only expected to be effective in the former.
Suprascapular nerve block vs. intramuscular local anesthetic against pain arising from the supraspinatus muscle.
Outcomes
Primary Outcome Measures
Intensity of shoulder pain on numeric rating scale
Secondary Outcome Measures
Pressure pain thresholds
Area of referred pain
Full Information
NCT ID
NCT02377180
First Posted
February 11, 2015
Last Updated
January 16, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT02377180
Brief Title
Capsaicin-induced Muscle Pain in Humans
Official Title
Capsaicin-induced Muscle Pain in Humans: From Investigating Central Pain Processing to Developing Clinical Applications
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
musculoskeletal pain, regional anesthesia, diagnostic nerve block, intramuscular capsaicin, referred pain, hyperalgesia, experimental pain, central hypersensitivity, human experimental pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Description
Intramuscular injection of capsaicin for the study of pain and hyperalgesia
Arm Title
Part 2
Arm Type
Active Comparator
Arm Description
Pain arising from supraspinatus muscle vs. pain arising from trapezius muscle. Nerve block is only expected to be effective in the former.
Arm Title
Part 3
Arm Type
Active Comparator
Arm Description
Suprascapular nerve block vs. intramuscular local anesthetic against pain arising from the supraspinatus muscle.
Intervention Type
Procedure
Intervention Name(s)
Intramuscular capsaicin injection
Intervention Description
Intramuscular injection of capsaicin: 50 mcg/0.5 ml
Intervention Type
Procedure
Intervention Name(s)
Suprascapular nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic infiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of shoulder pain on numeric rating scale
Time Frame
two hours
Secondary Outcome Measure Information:
Title
Pressure pain thresholds
Time Frame
two hours
Title
Area of referred pain
Time Frame
two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-80 years
Written informed consent
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Curatolo, M.D., Ph.D.
Organizational Affiliation
Department of Anesthesiology and Pain Therapy, University of Washington, Seattle WA, USA
Official's Role
Study Chair
Facility Information:
Facility Name
University Department of Anesthesiology and Pain Therapy,Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
12195523
Citation
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.
Results Reference
background
PubMed Identifier
10666547
Citation
Witting 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.
Results Reference
background
PubMed Identifier
22222688
Citation
Siegenthaler 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.
Results Reference
background
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Capsaicin-induced Muscle Pain in Humans
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