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The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.
Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg) |
|
| High dose | Experimental | All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGF | Drug | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle sensitivity | Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer. | Change from baseline at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure-induced referred pain | At three predetermined sites within the tibialis anterior muscle, a constant pressure stimulation (120% of PPT) is evoked by use of the pressure algometer. Subjects color their perceived sensation of pain on an electronic schematic of the lower legs using Navigate Pain. | Change from baseline at 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line Bay Sørensen, Ph.d stud. | Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Aalborg | 9220 | Denmark |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Double blind
| Activity-induced muscle soreness |
Subjects perform 10 dorsiflexions with each leg. The perceived muscle soreness is reported using a numeric rating scale (NRS) and the area of soreness is colored on an electronic schematic of the lower legs (Navigate Pain). |
| Change from baseline at 3 weeks |
| Pain intensity | Subjects rate their perceived pain intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz. | Assessed continuously at 0-5 min during the injections at each leg |
| Muscle soreness Diary | Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp | Change from baseline at 3 weeks |
| Activity-induced muscle soreness Diary | Subjects perform 10 dorsiflexions with each leg. The perceived muscle soreness is reported using a numeric rating scale (NRS) and the area of soreness is colored on an electronic schematic of the lower legs (Navigate Pain). The activity is performed at home on days in between the sessions | Change from baseline at 1 week |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |