|- candidate number||3022|
|- NTR Number||NTR1208|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mrt-2008|
|- Secondary IDs||NL21128.091.08 |
|- Public Title||Effectiveness of manual therapy (according to the dutch school for Manual Therapy Utrecht) and physical therapy in patients with subacute and chronic non-specific neck pain. A randomized clinical trial.|
|- Scientific Title||Effectiveness of manual therapy (according to the dutch school for Manual Therapy Utrecht) and physical therapy in patients with subacute and chronic non-specific neck pain. A randomized clinical trial.|
|- ACRONYM||NECKproject (Nederlands Effectonderzoek Cervicale Klachten)|
|- Healt Condition(s) or Problem(s) studied||Neck pain|
|- Inclusion criteria||1. Patients with at least two weeks of neck pain |
2. Last episode starts at a maximum of one year ago
3. Age between 18 and 70 years
4. Patient is willing to undergo the treatment
5. Neck pain is mechanical and can be provocated by movements or postures
6. Neck pain is the main problem to treatment
7. Neck pain may also give pain in the upper arm or cervicogene headaches
|- Exclusion criteria||1. Appearance of “red flags” |
2. Cervical surgery in the past
4. Whiplash trauma
5. Health conditions with may disturb the treatment or makes it impossible to undergo the treatment.
6. Not enough understanding of the Dutch questionnaires
7. Undergoing treatments like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture, exercise therapy according tot Cesar or Mensendieck during the last three months
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||1-mrt-2011|
|- Target number of participants||180|
|- Interventions||Manual therapy (according to the dutch school for Manual Therapy Utrecht) and physical therapy (usual care)|
|- Primary outcome||Global Perceived Effect (GPE) and the NDI-DV (Neck disability index) will be applied.|
|- Secondary outcome||VAS (Visual Analogue Scale) for pain and SF36 (Quality of life). The MHLC (Multidimensional Health Locus of Control), credibility/ expectancy, FABQ-DLV (Fear Avoidance Beliefs Questionnaire) will be measured to answer secondary questions.|
|- Timepoints||0-3-7-13-26-52 weeks|
|- Trial web site||http://www.neckproject.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. R.A.B. Oostendorp |
|- CONTACT for SCIENTIFIC QUERIES||Drs. R.A.B. Oostendorp |
|- Sponsor/Initiator ||University Medical Center St. Radboud, Neckprojectgroup|
(Source(s) of Monetary or Material Support)
|- Brief summary||Manual Therapy applied to patients with non-specific neck pain has been investi-gated several times, both internationally and within the Netherlands. In the Netherlands different types of manual therapy treatment exist. To date Manual Therapy as practiced under the Utrecht School (one of the existing kinds) hasn’t been subject of a randomised controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy.
Objective of the study: The RCT will investigate the effectiveness of Manual Therapy according to the Utrecht School of Manual Therapy in the short and long-term up to 52 weeks in patient with sub acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect will be measured.
Study design: The study is a single blind randomized controlled trial.
Study population: Men and women aged 18 to 70 years with neck pain for at least two weeks.
Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks.
Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the NDI-DV (Neck disability index) will be applied.
Secondary study parameters / outcome of the study: VAS (Visual Analogue Scale) for pain and SF36 (Quality of life). The MHLC (Multidimensional Health Locus of Control), credibility/ expectancy questionnaire, FABQ-DLV (Fear Avoid-ance Beliefs Questionnaire) will be measured to answer secondary questions.
Data will be collected at baseline, 3, 7, 13, 26 and 52 weeks.
|- Main changes (audit trail)|
|- RECORD||20-jan-2008 - 14-feb-2011|