HyperalgesiaEarly Phase 1NCT03217942
Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
A Early Phase 1 study testing NGF in people with Hyperalgesia and Healthy Subjects, run by Aalborg University at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia, Healthy Subjects
- What is being tested?
- NGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2017to 1 Oct 2017
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and pain free volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperalgesia, Healthy Subjects
- Being tested
- NGF
- Keywords
- Muscle soreness, NGF-induced pain, Pain model, Long-lasting sensitization
- Medical subject headings
- Hyperalgesia, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGFDrug
Also called Beta-Nerve Growth Factor, Human
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: NGF |
| 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) Receives: Drug: NGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sensitivity
Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.
Measured: Change from baseline at 3 weeks
Secondary outcomes (5)
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.
Measured: Change from baseline at 3 weeks
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Line Bay Sørensen, Aalborg University
- Investigators
- Line Bay Sørensen, Ph.d stud., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217942
- Sponsor's protocol ID
- N-2017-0007
- Status last verified
- Jan 2018
- First submitted
- 10 Jul 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
- ClinicalTrials.gov ID
- NCT03217942
- Acronym / sponsor ID
- N-2017-0007
- Conditions
- Hyperalgesia, Healthy Subjects
- Keywords
- Muscle soreness, NGF-induced pain, Pain model, Long-lasting sensitization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: NGFAll 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 | Drug: NGFAll 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) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy and pain free volunteers
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| NGFAlso: Beta-Nerve Growth Factor, HumanIntramuscular injection | Drug | High dose, Low dose |
Primary outcome
Muscle sensitivity
Time frame: Change from baseline at 3 weeks
Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.
5 secondary outcomes
Pressure-induced referred pain
Time frame: Change from baseline at 3 weeks
Activity-induced muscle soreness
Time frame: Change from baseline at 3 weeks
Pain intensity
Time frame: Assessed continuously at 0-5 min during the injections at each leg
Muscle soreness Diary
Time frame: Change from baseline at 3 weeks
Activity-induced muscle soreness Diary
Time frame: Change from baseline at 1 week
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 11 Jan 2018.
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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.
Line Bay Sørensen, Ph.d stud. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NGF in people with Hyperalgesia and Healthy Subjects, run by Aalborg University at 1 site in Denmark.
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 1 inclusion and 8 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 11 Jan 2018. 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 Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Muscle sensitivity (time frame: Change from baseline at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2018.