NCT03848247

Brief Summary

This study investigates if/how an experimentally applied muscle pain/soreness, lasting for some days may affect brain activity, balance, movement patterns, muscle function and pain sensitivity in a healthy population

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 16, 2019

Last Update Submit

February 19, 2019

Conditions

HealthyNeck Pain

Outcome Measures

Primary Outcomes (3)

  • Change in pressure pain threshold (PPT) measured with a handheld pressure algometer

    PPT will be assessed over head, neck, arm and leg sites.

    Day 0, 2,4 and 15

  • Change in motor evoked potentials

    Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles

    Day 0, 4 and 15

  • Change in Body movement

    3D recordings of body movements

    Day 0, 4 and 15

Secondary Outcomes (6)

  • Change in muscle activity (EMG)

    Day 0, 4 and 15

  • Change in standing balance

    Day 0, 4 and 15

  • Change in perceived pain: McGill Pain Questionnaire

    Day 0, 2,4 and 15

  • Disability

    Day 0, 2,4 and 15

  • Pain Catastrophizing Scale (13 item questionnaire)

    Day 2

  • +1 more secondary outcomes

Study Arms (2)

Control group

EXPERIMENTAL

Participants will be injected with 0.5ml Isotonic saline into a neck muscle

Other: Injection of Isotonic saline

Neck pain

EXPERIMENTAL

Participants will be injected with 0.5ml NGF into the a neck muscle

Other: Injection of NGF

Interventions

Injection of Isotonic salineOTHER

Half the participants will be injected in a neck muscle with isotonic saline (Control group) and the other half will get NGF (Neck pain group).

Control group
Injection of NGFOTHER

Half the participants will be injected in a neck muscle with NGF (Neck pain group).

Neck pain

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women aged 18-50 years
  • Only for sub-projects 1 and 2: Right-handed
  • Able to speak, read and understand Danish and English

You may not qualify if:

  • Pain from the neck or shoulder area during the past 6 months
  • Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
  • Former surgery in neck or shoulder
  • Current or previous chronic or recurrent pain condition
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Regular use of analgesics
  • Abnormally disrupted sleep in the last 24 hours preceding the experiment
  • Lack of ability to cooperate
  • Unable to pass the TASS safety screening questionnaire for TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Of Health Science and Technology, SMI, Aalborg University

Aalborg, 9220, Denmark

RECRUITING

Related Publications (1)

  • Simonsen MB, Cancino EE, de Brito Silva P, Sorensen LB, Hirata RP, Christensen SWM. The impact of prolonged experimental neck pain on walking stability and gait kinematics - A parallel-group study. Clin Biomech (Bristol). 2023 Jan;101:105869. doi: 10.1016/j.clinbiomech.2022.105869. Epub 2022 Dec 23.

    PMID: 36584579DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steffan W Christensen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffan W Christensen, PhD

CONTACT

+45 99408889stc@hst.aau.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 20, 2019

Study Start

January 21, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

DK(1)