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Head Repositioning Accuracy During Experimental Neck Pain

Primary Purpose

Healthy, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Injection of hypertonic saline
Injection of Isotonic saline
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Painful condition

Control condition

Arm Description

Participants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle

Participants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle

Outcomes

Primary Outcome Measures

Change in head repositioning accuracy
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.

Secondary Outcome Measures

Change in perceived pain
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.
Change in perceived performance of head repositioning accuracy test
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)

Full Information

First Posted
June 26, 2019
Last Updated
June 27, 2019
Sponsor
Aalborg University
Collaborators
The Danish Rheumatism Association
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1. Study Identification

Unique Protocol Identification Number
NCT04001218
Brief Title
Head Repositioning Accuracy During Experimental Neck Pain
Official Title
Neck Pain - Motor and Sensory Aspects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2015 (Actual)
Primary Completion Date
September 22, 2015 (Actual)
Study Completion Date
September 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
The Danish Rheumatism Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Neck Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Painful condition
Arm Type
Experimental
Arm Description
Participants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle
Arm Title
Control condition
Arm Type
Experimental
Arm Description
Participants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle
Intervention Type
Drug
Intervention Name(s)
Injection of hypertonic saline
Other Intervention Name(s)
Hypertonic saline (5.8%)
Intervention Description
Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)
Intervention Type
Drug
Intervention Name(s)
Injection of Isotonic saline
Other Intervention Name(s)
Isotonic saline (0.9%)
Intervention Description
Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)
Primary Outcome Measure Information:
Title
Change in head repositioning accuracy
Description
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.
Time Frame
Within session (session lasts approximately 2 hours)
Secondary Outcome Measure Information:
Title
Change in perceived pain
Description
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.
Time Frame
Within session (session lasts approximately 2 hours)
Title
Change in perceived performance of head repositioning accuracy test
Description
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)
Time Frame
Within session (session lasts approximately 2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffan W Christensen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Of Health Science and Technology, SMI, Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

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Head Repositioning Accuracy During Experimental Neck Pain

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