The Effect of Experimental Neck Pain in Healthy Participants

NCT ID: NCT03848247

Last Updated: 2019-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-05-01

Brief Summary

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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

Detailed Description

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All included healthy volunteers will participate in test-sessions on 4 separate days over approximately 2 weeks.

During the study participants will be randomised into and either a control group (injection of isotonic saline into a neck muscle) or neck pain group (injection of Nerve Growth Factor (NGF) into a neck muscle).

Alle participants tested with regards to:

Brain activity related to neck muscles will be estimated using TMS Balance will be tested using a force place Body movements will be recorded using 3D tracking Muscle activity will be estimated using electromyography (EMG)

Conditions

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Healthy Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type EXPERIMENTAL

Injection of Isotonic saline

Intervention Type OTHER

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).

Neck pain

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

Group Type EXPERIMENTAL

Injection of NGF

Intervention Type OTHER

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

Interventions

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Injection of Isotonic saline

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).

Intervention Type OTHER

Injection of NGF

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Steffan Wittrup Christensen

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffan W Christensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Steffan W Christensen, PhD

Role: CONTACT

+45 99408889

Facility Contacts

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Steffan W Christensen, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36584579 (View on PubMed)

Other Identifiers

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N-20180063_Sub-project_1

Identifier Type: -

Identifier Source: org_study_id

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