The use of a three dimensional untrasound-based measurement device for the evaluation of subjects with and without neckpain

Transcription

1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title The use of a three dimensional untrasound-based measurement device for the evaluation of subjects with and without neckpain Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language The objective of this study is to evaluate wheater neckpain can be detected by altered motion patterns. Motions analysis will be done by ultrasound. If this device can be validated part of the patients with neckpain may be prevented from x-ray exposítion in future. For that purpose movemnet+ characteristics of healthy subjects will be compared to those of Patientes with neck pain as a first step. Brief Summary in Scientific Language The purpose of the study is to compare movement characteristic of healthy subjects to those of patients with acute and chronic neck pain. By analyziing velocity and acceleration typical movement pattern of subjects with and without neckpain will be identified and compared to validated clinical tests, x-rays and psychosocial varaibles. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 40/09, Ethik-Kommission des Fachbereichs Medizin der Philipps- Universität Marburg Page 1 of 5

2 Secondary IDs Health condition or Problem studied ICD10: M Cervicalgia ICD10: [---]* - [---]* Interventions/Observational Groups Arm 1: Motions patterns of healthy subjects will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires Arm 2: Motions patterns of patients with acute neck pain will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires Arm 3: Motions patterns of patients with chronic neck pain will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires Characteristics Study Type: Non-interventional Study Type Non-Interventional: Other Allocation: Non-randomized controlled trial Blinding: Single blind Who is blinded: [---]* Control: Other Purpose: Diagnostic Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Primary Outcome Motion patterns (velocity and acceleration) are investigated by means of ultrasound topometry. Prímary endpoints are peaks within the acceleration curve, for which an analysis of frequency will be performed. Page 2 of 5

3 Secondary Outcome Data from physical and psychological evaluation from validated quationnaires for mobility, pain, disability, anxiety, depression, fear-avoidance-beliefs. quality of life. Countries of recruitment DE Locations of Recruitment Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2010/04/22 Target Sample Size: 180 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional Inclusion Criteria Patients with neck pain and subjects without pain and symptoms during the last 12 months and without medical interventions for neck pain during the last 5 years. Exclusion criteria Any conditions where active movement may harm the patient irre-versibly or severely, mental dísorders (except anxiety and depression), severe nerve root or spinal cord compression with neurological signs, Neurological symptoms during cervical movements, Vertigo, Patients with running lawsuit where neck pain plays a role, Patients aiming at retirement Page 3 of 5

4 Addresses Primary Sponsor Baldinger Strasse 1 Contact for Scientific Queries Baldinger Strasse 1 Contact for Public Queries Fachbereoich Medizin Baldfnger Strasse 1 Fax: Sources of Monetary or Material Support Page 4 of 5

5 Institutional budget, no external funding (budget of sponsor/pi) Baldinger Srrasse 1 Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5