Head Repositioning Accuracy During Experimental Neck Pain

June 27, 2019 updated by: Steffan Wittrup Christensen, Aalborg University

Neck Pain - Motor and Sensory Aspects

This study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy volunteers will participate in a single session study with a crossover design.

During the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.

Head repositioning accuracy will be assessed with and without performing a cognitive task.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Dept. Of Health Science and Technology, SMI, Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women aged 18-50 years
  • Right handed
  • Able to speak, read and understand Danish or English
  • Normal pain free neck and shoulder range of motion

Exclusion Criteria:

  • Pain from the neck or shoulder area
  • Prior surgery in neck or shoulder
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Self reported neurologic, musculoskeletal or mental illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Painful condition
Participants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle
Drug: Injection of hypertonic saline
Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)
Other Names:
  • Hypertonic saline (5.8%)
EXPERIMENTAL: Control condition
Participants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle
Drug: Injection of Isotonic saline
Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)
Other Names:
  • Isotonic saline (0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in head repositioning accuracy
Time Frame: Within session (session lasts approximately 2 hours)
Participants will be blindfolded and asked asked to, from a neutral position, to move the head into full range of motion before returning to to a neutral position again. The difference between the start and end position will be used as an estimate of head repositioning error.
Within session (session lasts approximately 2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived pain
Time Frame: Within session (session lasts approximately 2 hours)
Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain, by drawing on body charts and choosing words from the McGill Pain Questionnaire.
Within session (session lasts approximately 2 hours)
Change in perceived performance of head repositioning accuracy test
Time Frame: Within session (session lasts approximately 2 hours)
Likert scores of the perceived difficultness (0=no problems, 1=minimally difficult, 2=somewhat difficult, 3=fairly difficult, 4= very difficult, 5=unable to perform)
Within session (session lasts approximately 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

The Danish Rheumatism Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2015

Primary Completion (ACTUAL)

September 22, 2015

Study Completion (ACTUAL)

September 22, 2015

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N20120018_Subproject 1d

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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