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Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model

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ClinicalTrials.gov Identifier: NCT03217942
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Line Bay Sørensen, 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.

Condition or disease Intervention/treatment Phase
Hyperalgesia Healthy Subjects Drug: NGF Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Basic Science
Official Title: Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Arm Intervention/treatment
Experimental: Low dose
All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)
Drug: NGF
Intramuscular injection
Other Name: Beta-Nerve Growth Factor, Human

Experimental: High dose
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)
Drug: NGF
Intramuscular injection
Other Name: Beta-Nerve Growth Factor, Human




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pressure-induced referred pain [ Time Frame: 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.

  2. Activity-induced muscle soreness [ Time Frame: 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).

  3. Pain intensity [ Time Frame: 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.

  4. Muscle soreness Diary [ Time Frame: 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

  5. Activity-induced muscle soreness Diary [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy and pain free volunteers

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217942


Locations
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Denmark
Aalborg University
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Investigators
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Principal Investigator: Line Bay Sørensen, Ph.d stud. Aalborg University

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Responsible Party: Line Bay Sørensen, Ph.d. stud., Aalborg University
ClinicalTrials.gov Identifier: NCT03217942     History of Changes
Other Study ID Numbers: N-2017-0007
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Line Bay Sørensen, Aalborg University:
Muscle soreness
NGF-induced pain
Pain model
Long-lasting sensitization
Additional relevant MeSH terms:
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Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms