Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
- Registration Number
- NCT03217942
- Lead Sponsor
- Aalborg University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Healthy and pain free volunteers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low dose NGF 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 NGF 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)
- Primary Outcome Measures
Name Time Method Muscle sensitivity Change from baseline at 3 weeks Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.
- Secondary Outcome Measures
Name Time Method Pressure-induced referred pain Change from baseline at 3 weeks 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.
Muscle soreness Diary Change from baseline at 3 weeks Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp
Pain intensity Assessed continuously at 0-5 min during the injections at each leg 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.
Activity-induced muscle soreness Change from baseline at 3 weeks 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).
Activity-induced muscle soreness Diary Change from baseline at 1 week 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
Trial Locations
- Locations (1)
Aalborg University
🇩🇰Aalborg, Denmark