BeNe chiropractic cohort study: role of the psychosocial factors in patients with neck and low-back pain (WC2008-095)

Methods

Starting date: 01/09/2009

Study design and source population
Data is to be collected using a prospective, multi-center, practice-based cohort study design. Subjects, who fulfil the inclusion criteria, are to be recruited by chiropractors in their private clinics throughout the Netherlands and Belgium, and are to be followed-up at various intervals up to 12 months. Each participating chiropractor will be asked to recruit 15 consecutive new patients.

Recruitment of chiropractors and subjects
Chiropractor inclusion criteria and recruitment. All chiropractors, who are members in good standing of the Netherlands Chiropractors’ Association (NCA) and Belgian Chiropractors Association (BCA), are to be invited to participate. Participating chiropractors will be required to carry out the examination and treatment personally. Recruitment will be pursued by a number of means including a flyer mailed to all NCA members, by personal invitation, and through a presentation at a national chiropractic association meeting.

Patient inclusion and exclusion criteria. All new patients between the ages of 18-65 years with neck and/or low-back pain of any duration, who have not undergone chiropractic care or manual therapy in the prior 3 months, are to be eligible for recruitment and consecutively included. Neck pain is to be defined and include those with neck and neck-related pain, that is cervico-thoracic and/or periscapular pain, while low-back pain will include those with low-back related pain, that is pain radiating to the sacroiliac joint and gluteal region. Although inclusion is based upon a primary complaint of neck and/or low-back pain, patients who also have pain in other areas are not to be excluded, including those with suspected radicular or sciatic pain. Patients must also have a basic understanding of the Dutch or Flemish French language, and independently able to complete the series of questionnaires. The inclusion period is to be 8 months, with the expected start of data collection to be April 2009.

Subjects are to be excluded if they have a red flag (e.g. suspected infection, fracture, tumor, metastasis, or intravenous drug use), whiplash-associated disorders, or any other condition thought to be a contraindication for treatment (e.g. luxation or instability of the vertebral articulations). This is to be left to the discretion of the chiropractor.

Study protocol
Prior to the start of data collection, training sessions are to be conducted with the chiropractors throughout the Netherlands and Belgium in order to present the study methods and ensure consistency in applying them. Both the chiropractor and his/her assistant(s) will be asked to attend, but at least, one representative will be required to attend.

The protocol to be followed is similar to a recent study conducted at the EMGO-Institute/VUmc by Dr. SM Rubinstein, and therefore, do not anticipate any major problems in this regard.

Data collection and clinical outcome variables
Procedure. Data are to be collected from patients at baseline within the individual practices by means of a self-administered questionnaire. All forms are to be pre-coded in order to ensure anonymity. Envelopes are to be provided to the patients in which to place their completed questionnaires in order to facilitate an unbiased response. Follow-up is to be conducted from a central data collection center at the university either electronically via the internet, or on paper via the mail, if the latter is requested by the patient. If the participant fails to respond to a written reminder at follow-up, a shortened structured telephone interview is to be conducted, consisting of the principal outcome measures.

Covariates. The covariates to be assessed at baseline are to comprise the following areas: sociodemographic, disease specific, clinical, and psychological. Specifically, the following psychological factors are to be assessed using validated questionnaires: Catastrophising, distress, somatisation, kinesiophobia, depression, and anxiety. Additional data is to be collected on the chiropractor regarding basic sociodemographic information, as well as clinical data resulting from the physical examination of the patient using validated tests.