Pain ResponseEarly Phase 1NCT03844243
Exercise-induced Ischemia and the Influence of Pain Modulation in a Nerve Growth Factor (NGF) Model
A Early Phase 1 study testing NGF and Isotonic-saline in people with Pain Response and Hyperalgesia, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged 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
- Pain Response, Hyperalgesia, 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
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Feb 2019to 30 Jun 2019
- 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.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Aalborg, 9220
Line Bay Sørensen, Ph.d stud., 99404874, lbs@hst.aau.dk
About this study
Official title: Interaction Between NGF and Exercise-induced Ischemia, and the Influence of the Pain Modulating System in a Prolonged NGF Sensitized Muscle.
The purpose of this study is to investigate responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged NGF-sensitized muscle. Additionally, the influence of the pain modulating system on prolonged NGF muscle hypersensitivity caused by peripheral mechanisms and central mechanisms will also be investigated.
Read the detailed description
The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to facilitate pain responses and that over time the pain modulation system is responsible for a subsequent reduction in muscle sensitivity towards mechanical pressure and a decrease in pain intensity following a period of NGF-induced muscle hypersensitivity.
- Conditions
- Pain Response, Hyperalgesia, Healthy Subjects
- Being tested
- NGF, Isotonic-saline
- Keywords
- NGF-induced hyperalgesia, Exercise-induced ischemic pain, Pain modulation, 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 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.
After 4 weeks:
All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. Receives: Drug: NGF; Drug: Isotonic-saline |
| Control condition + NGF condition | Experimental | All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle.
After 4 weeks:
All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. Receives: Drug: NGF; Drug: Isotonic-saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle pain sensitivity (PPTs values) assessed by pressure algometer
Pressure pain thresholds (PPTs) are assessed over the dominant tibialis anterior muscle using a handhold pressure algometer.
Measured: Change from baseline at 3 week
Secondary outcomes (4)
Ischemic-induced pain intensity
Subjects perform a repeated static exercise with their 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 11-point numeric rating scale (NRS) rating from 0 (no pain) to 10 (worst pain imaginable).
Measured: Assessed right after the exercise has been performed, change from baseline at 3 weeks
Functional muscle pain
Subjects evaluate their muscle pain during movement using a 7-point Likert Scale for lower limp rating from 0 (a complete absence of pain) to 6 (a severe pain that limits my ability to move).
Measured: Change from baseline at 3 weeks
Conditioning pain modulation (CPM) efficacy
A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.
Measured: Change from baseline at 3 weeks
Temporal summation of pain
10 repeated stimuli will be applied and subjects will be asked to rate the pain for each individual stimuli on a 11-point visual analogue scale (VAS) rating from 0 (no pain) to 10 (worst pain imaginable)
Measured: Change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start18 Feb 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ResponseStudies 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
- 20 participants (estimated)
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, PhD. stud., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844243
- Sponsor's protocol ID
- N-2017-0007_S3
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between NGF and Exercise-induced Ischemia, and the Influence of the Pain Modulating System in a Prolonged NGF Sensitized Muscle.
- ClinicalTrials.gov ID
- NCT03844243
- Acronym / sponsor ID
- N-2017-0007_S3
- Conditions
- Pain Response, Hyperalgesia, Healthy Subjects
- Keywords
- NGF-induced hyperalgesia, Exercise-induced ischemic pain, Pain modulation, NGF pain model
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 18 Feb 2019 (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 responses of pain and the maintenance of mechanical muscle hypersensitivity following an acute exercise-induced ischemic condition repeated over time in a prolonged NGF-sensitized muscle. Additionally, the influence of the pain modulating system on prolonged NGF muscle hypersensitivity caused by peripheral mechanisms and central mechanisms will also be investigated.
Detailed description
The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to facilitate pain responses and that over time the pain modulation system is responsible for a subsequent reduction in muscle sensitivity towards mechanical pressure and a decrease in pain intensity following a period of NGF-induced muscle hypersensitivity.
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 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. |
| Control condition + NGF condition | Experimental | Drug: NGF, Drug: Isotonic-salineAll participants will receive 3 single injection of isotonic-saline (9%/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. After 4 weeks: All participants will receive 3 single injection of NGF (1ug/0.5ml) repeated over 3 separate days in their dominant tibialis anterior muscle. |
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 pain sensitivity (PPTs values) assessed by pressure algometer
Time frame: Change from baseline at 3 week
Pressure pain thresholds (PPTs) are assessed over the dominant tibialis anterior muscle using a handhold pressure algometer.
4 secondary outcomes
Ischemic-induced pain intensity
Time frame: Assessed right after the exercise has been performed, change from baseline at 3 weeks
Functional muscle pain
Time frame: Change from baseline at 3 weeks
Conditioning pain modulation (CPM) efficacy
Time frame: Change from baseline at 3 weeks
Temporal summation of pain
Time frame: Change from baseline at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- 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, PhD. 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 Pain Response and Hyperalgesia, 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: status not confirmed, as of the sponsor's last update on 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Line Bay Sørensen, PhD. stud. (52373229, lbs@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle pain sensitivity (PPTs values) assessed by pressure algometer (time frame: Change from baseline at 3 week). 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 18 Feb 2019.