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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 10, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date January 11, 2018
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03217942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • 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.
  • 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).
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Official Title  ICMJE Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose: Basic Science
Condition  ICMJE
  • Hyperalgesia
  • Healthy Subjects
Intervention  ICMJE Drug: NGF
Intramuscular injection
Other Name: Beta-Nerve Growth Factor, Human
Study Arms  ICMJE
  • 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)
    Intervention: Drug: NGF
  • 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)
    Intervention: Drug: NGF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03217942
Other Study ID Numbers  ICMJE N-2017-0007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Line Bay Sørensen, Aalborg University
Study Sponsor  ICMJE Aalborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Line Bay Sørensen, Ph.d stud. Aalborg University
PRS Account Aalborg University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP