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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03217942 |
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Date of registration:
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10/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
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Scientific title:
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Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model |
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Date of first enrolment:
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July 1, 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03217942 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Line Bay Sørensen, Ph.d stud. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aalborg University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy and pain free volunteers
Exclusion Criteria:
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, mental illnesses, or psychiatric diseases.
- Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage,
connective tissue)
- Participation in other pain trials throughout the study period
- Lack of ability to cooperate
- Taking any analgesic 24 hours before the injections
- Performing any strenuous leg exercise through out the study period causing sore
muscles
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hyperalgesia
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Healthy Subjects
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Intervention(s)
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Drug: NGF
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Primary Outcome(s)
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Muscle sensitivity
[Time Frame: Change from baseline at 3 weeks]
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Secondary Outcome(s)
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Pain intensity
[Time Frame: Assessed continuously at 0-5 min during the injections at each leg]
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Muscle soreness Diary
[Time Frame: Change from baseline at 3 weeks]
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Activity-induced muscle soreness Diary
[Time Frame: Change from baseline at 1 week]
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Pressure-induced referred pain
[Time Frame: Change from baseline at 3 weeks]
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Activity-induced muscle soreness
[Time Frame: Change from baseline at 3 weeks]
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Secondary ID(s)
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N-2017-0007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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