Neck Pain Clinical Trial
— NECKprojectOfficial title:
Effectiveness of Manual Therapy and Physical Therapy in Patients With Subacute and Chronic Non-specific Neck Pain. A Randomized Controlled Trial.
Background of the study: Manual Therapy applied to patients with non-specific neck pain has
been investigated several times, both internationally and nationally. In the Netherlands
different types of manual therapy treatment exist. Manual Therapy, as practiced under the
Utrecht School, has not been subject of a randomized controlled trial. There is a need to
evaluate the effectiveness of this type of manual therapy.
Objective of the study: This trial will investigate the effectiveness 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 are the outcome variables.
Study design: The study is a single blind randomized controlled trial.
Study population: Men and women aged 18 to 70 years old 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 Neck
disability index (NDI-DV ) will be applied.
Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and
SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ),
Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will
also be measured.
Status | Completed |
Enrollment | 180 |
Est. completion date | February 2014 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with at least two weeks of neck pain - Last episode starts at a maximum of one year ago - Age between 18 and 70 years - Patient is willing to undergo the treatment - Neck pain is mechanical and can be provocated by movements or postures of the neck - Neck pain is the main problem to treat - Neck pain may also give pain in the upper arm or cervicogenic headaches Exclusion Criteria: - Appearance of "red flags" - Cervical surgery in the past - Pregnancy - Whiplash trauma - Health conditions with may disturb the treatment or makes it impossible to undergo the treatment. - Not enough understanding of the Dutch questionnaires - Undergoing treatments like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture, other types of exercise therapy during the last three months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | NECKproject.nl | Dordrecht | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Perceived Effect (GPE), Neck disability index (NDI-DV ) | 0-3-7-13-26-52 weeks | No | |
Secondary | Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS)for pain and SF36 (Quality of life). Multidimensional Health Locus of Control (MHLC), credibility/ expectancy, Fear Avoidance Beliefs Questionaire (FABQ-DLV) | 0-3-7-13-26-52 weeks | No |
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