HyperalgesiaEarly Phase 1NCT03470038
Interaction Between NGF and Acute Exercise-induced Ischemia
A Early Phase 1 study testing NGF and Isotonic saline in people with Hyperalgesia and Pain Response, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia, Pain Response, Healthy Subjects
- What is being tested?
- NGF and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2018to 15 Jun 2018
- 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
Official title: The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia
The purpose of this study is to investigate pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.
Read the detailed description
Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.
It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.
- Conditions
- Hyperalgesia, Pain Response, Healthy Subjects
- Being tested
- NGF, Isotonic saline
- Keywords
- NGF-induced pain, Ischemia-induced pain, Hyperalgesia, NGF pain model
- Medical subject headings
- Hyperalgesia
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
Isotonic salineDrug
Also called Control
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| NGF condition + Control condition | Experimental | All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg Receives: Drug: NGF; Drug: Isotonic saline |
| Control condition + NGF condition | Experimental | All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg
After 4 weeks:
All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg Receives: Drug: NGF; Drug: Isotonic saline |
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 non-dominant tibialis anterior muscle using a handhold pressure algometer.
Measured: Change from baseline at 1 week
Secondary outcomes (3)
Ischemic-induced pain intensity
Subjects perform 45 dorsiflexions with their non-dominant leg while a cuff is mounted over the knee to occlude the blodflow from the muscle (ischemia) Subjects subsequently rate their perceived pain intensity verbally on a numeric rating scale (NRS)
Measured: Assessed right after the dorsiflexions have been performed
Functional muscle pain
Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp
Measured: Change from baseline at 1 week
Muscle pain diary
Subjects evaluate their muscle pain during movement using a Likert Scale for lower limp and perceived pain intensity at rest on a numeric rating scale (NRS). The diary is filled out at home on days between 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 posted19 Mar 2018
- Study start15 Mar 2018
- Primary completion15 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- NCT03470038
- Sponsor's protocol ID
- N-2017-0007_S2
- Status last verified
- Feb 2019
- First submitted
- 13 Mar 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorensen LB, Gazerani P, Graven-Nielsen T. Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain. Eur J Pain. 2019 Nov;23(10):1814-1825. doi: 10.1002/ejp.1455. Epub 2019 Aug 5.
PubMed 31314952
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia
- ClinicalTrials.gov ID
- NCT03470038
- Acronym / sponsor ID
- N-2017-0007_S2
- Conditions
- Hyperalgesia, Pain Response, Healthy Subjects
- Keywords
- NGF-induced pain, Ischemia-induced pain, Hyperalgesia, NGF pain model
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 19 Mar 2018 (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 pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.
Detailed description
Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.
It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGF condition + Control condition | Experimental | Drug: NGF, Drug: Isotonic salineAll participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg |
| Control condition + NGF condition | Experimental | Drug: NGF, Drug: Isotonic salineAll participants will receive five injections with isotonic saline (9%/0.5ml) into the tibialis anterior muscle in their non-dominant leg After 4 weeks: All participants will receive five injections with NGF (1ug/0.5ml) into the tibialis anterior muscle in their non-dominant 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 | Control condition + NGF condition, NGF condition + Control condition |
| Isotonic salineAlso: ControlIntramuscular injection | Drug | Control condition + NGF condition, NGF condition + Control condition |
Primary outcome
Muscle sensitivity
Time frame: Change from baseline at 1 week
Pressure pain thresholds (PPTs) are assessed over the non-dominant tibialis anterior muscle using a handhold pressure algometer.
3 secondary outcomes
Ischemic-induced pain intensity
Time frame: Assessed right after the dorsiflexions have been performed
Functional muscle pain
Time frame: Change from baseline at 1 week
Muscle pain 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 15 Feb 2019.
- Derived from this study: PubMed 31314952Sorensen LB, Gazerani P, Graven-Nielsen T. Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain. Eur J Pain. 2019 Nov;23(10):1814-1825. doi: 10.1002/ejp.1455. Epub 2019 Aug 5.
- Individual participant dataSharing planned: No
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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 and Isotonic saline in people with Hyperalgesia and Pain Response, 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 15 Feb 2019. 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 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470038, which also lists 1 linked publication.
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 15 Feb 2019.