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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04001218
Other study ID # N20120018_Subproject 1d
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2015
Est. completion date September 22, 2015

Study information

Verified date June 2019
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 22, 2015
Est. primary completion date September 22, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Injection of hypertonic saline
Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)
Injection of Isotonic saline
Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)

Locations

Country Name City State
Denmark Dept. Of Health Science and Technology, SMI, Aalborg University Aalborg

Sponsors (2)

Lead Sponsor Collaborator
Aalborg University The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within session (session lasts approximately 2 hours)
Secondary 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. Within session (session lasts approximately 2 hours)
Secondary 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) Within session (session lasts approximately 2 hours)
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