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Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671370
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Swanenburg, Balgrist University Hospital

Tracking Information
First Submitted Date January 29, 2016
First Posted Date February 2, 2016
Last Update Posted Date May 9, 2017
Study Start Date January 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2016)
Cervical Range of Motion (CROM) [ Time Frame: Baseline ]
The cervical range of motion will be measured using the CROM device
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2016)
  • Neck Disability Index [ Time Frame: Baseline ]
    Questionnaire, measuring the subjective restriction of the participant during activities of daily living
  • S-ROM-Neck [ Time Frame: Baseline ]
    Questionnaire, the participants will be asked to assess their ability to move there neck and if they feel restricted.
  • Interviews (personal,semi-structured guided, open-ended questions) in a one-to-one Setting. Recorded with a voice-recorder. [ Time Frame: Baseline ]
    10 of the participants will be asked to also take part in an interview.
Original Secondary Outcome Measures
 (submitted: February 1, 2016)
  • Neck Disability Index [ Time Frame: Baseline ]
    Questionnaire, measuring the subjective restriction of the participant during activities of daily living
  • S-ROM-Neck [ Time Frame: Baseline ]
    Questionnaire, the participants will be asked to assess their ability to move there neck and if they feel restricted.
  • Interviews [ Time Frame: Baseline ]
    10 of the participants will be asked to also take part in an interview.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study
Official Title Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study
Brief Summary This study there are any associations between objective and subjective outcome measures, measuring the cervical range of motion and if the restriction matter to the patient.
Detailed Description

Objective and subjective outcome measures are frequently used assessments in clinical practice.

The investigators will use different subjective and objective outcome measures to evaluate any possible associations, as well as to investigate if restrictions of movement matters to patients.

Additionally to the assessments tools the investigators will use interviews to extend the scope.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with neck pain of any duration
Condition Neck Pain
Intervention Other: Measurement of the range of motion of the cervical spine
There is no intervention. Only measurements and interviews are taken.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2016)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with any duration of neck pain
  • Men and women older than 18 years
  • Signed informed consent

Exclusion Criteria:

  • Disc herniation of the cervical spine
  • Spinal canal stenosis
  • Acute accidents
  • Surgery of the cervical spine
  • Pacemaker and / or defibrillator
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671370
Other Study ID Numbers 2015-00049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: no there is not
Responsible Party Swanenburg, Balgrist University Hospital
Study Sponsor Balgrist University Hospital
Collaborators Maastricht University
Investigators
Principal Investigator: Jaap Swanenburg, PhD Balgrist University Hospital
PRS Account Balgrist University Hospital
Verification Date May 2017