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Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders

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ClinicalTrials.gov Identifier: NCT02483091
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Andre Bussieres, McGill University

Brief Summary:

To assess the feasibility of conducting a larger cluster randomized controlled trial to facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e. implementation of multimodal care, into chiropractic clinical practice, designed to improve the management of patients with Non-Specific Neck Pain (NSNP) disorders.

To evaluate feasibility, the investigators will ascertain how well participating chiropractors and patients adhere to the study protocol and will solicit feedback from them about the overall usefulness of the content and format of the KT intervention. This study will determine planning for the main study and also the outcomes to be used as a primary outcome.


Condition or disease Intervention/treatment Phase
Neck Pain Behavioral: Multifaceted KT intervention Phase 1

Detailed Description:

The aim of this pilot study project is to determine the feasibility of implementing a multifaceted KT intervention to promote the use of multimodal care by chiropractors managing patients with NSNP.

Design: Cluster randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be randomized to receive either a theory-based tailored KT intervention in the experimental group or simply a printed copy of the guideline in the control group.

Study population and sample size: 30 chiropractors will be recruited from a random, nationally representative sample of 200 chiropractors. Each chiropractor will recruit five neck pain patients for a total of 150 patients.

The design of the KT intervention was informed by the results of a related qualitative study (Theoretical Domains Framework interviews) and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning (BAP) and a printed copy of the practice guideline (Bussières et al., 2015).

Primary feasibility outcomes for both chiropractors and patients include rates of: 1) recruitment, 2) study retention, and 3) adherence to the intervention (Tickle-Degnen, 2013). A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations e.g., exercise and self-care prescriptions, at study onset and at three months follow-up.

Secondary outcomes include whether or not the chiropractor's recommended multimodal care, scores on measures of behavioural constructs e.g., self-efficacy, knowledge.

Primary clinical outcomes for patients includes measures of pain intensity and neck pain-specific disability.

Analyses from this pilot study will focus on generating point estimates and corresponding 95% confidence intervals for parameters of a priori interest (e.g., recruitment, retention, adherence, pain intensity, neck disability index).

Discussion: The main strength of this study includes its use of a representative sample and randomized controlled design. The results of this study will inform the design of a larger cluster randomized controlled trial aimed at confirming the effectiveness and increasing the use of multimodal care by chiropractors managing patients with NSNP.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Chiropractors Can Do: Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders: A Pilot Cluster Randomized Controlled Trial
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multifaceted KT intervention
Webinars, online vignettes and e-module, copy of guideline recommendations
Behavioral: Multifaceted KT intervention

The intervention consists of three webinars followed by the quiz, two online case scenario and a video on BAP model plus a printed copy of Clinical Practice Guideline (CPGs) on NSNP.

After completing these modules and learning the key strategies, each chiropractor will recruit five neck pain patients and implement the strategies on their patients to measure the clinical outcomes for a follow-up of three months.

The control group will receive only a printed copy of CPGs. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations at study onset and at three months.


No Intervention: Control
Printed copy of guideline recommendations



Primary Outcome Measures :
  1. Feasibility outcome (composite outcome measure) [ Time Frame: 6 months ]

    The main outcome of interest is feasibility that includes recruitment, retention, adherence to the study protocol and effectiveness potential.

    Recruitment rate include: 1) eligibility rate (number of eligible chiropractors and patients divided by invited chiropractors or patients) and 2) participation rate (number agreeing to participate divided by eligible chiropractors or patients).

    Retention rate: Number of chiropractors and patients who completed all outcome measures at baseline and at 3 month follow-up plus rate of completion of questionnaires by chiropractors (measures of behavioural constructs) and patients (clinical outcomes).

    For chiropractors, rate of adherence includes attendance of all 3 webinars, associated quizzes, 2 clinical vignettes and the self-management learning module; For patients, rate of adherence includes follow-up visits, prescribed home exercise and physical activity.



Secondary Outcome Measures :
  1. Scores on measures of behavioural constructs (composite outcome measure) [ Time Frame: 6 months ]
    For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.


Other Outcome Measures:
  1. Pain [ Time Frame: 3 months (before and at the end of treatment) ]
    Self-rated level of pain on an 11 points continuous Visual Analogue Scale (VAS)

  2. Disability [ Time Frame: 3 months (before and at the end of treatment) ]
    Self-rated disability due to neck pain measured on the Neck Disability Index (NDI). Scale range and subscales:10 items in total, each item is scored from 0-5 ("0" = no disability and "5" = full disability) for a total of 50

  3. Satisfaction with care [ Time Frame: 3 months (end of treatment) and 3 months of follow-up ]
    Self-rated satisfaction with care measured on the Short Form Patient Satisfaction Questionnaire (PSQ-18). Scale range and subscales:10 items in total, each item is scored from 1-5 ("1" = strongly agree and "5" = strongly disagree)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Chiropractors

Inclusion criteria:

  • Registered with their professional licensing boards and in private practice in the Canada;
  • Graduated at least one year ago;
  • Provide chiropractic treatment to a minimum of two adults (age 18-65) with neck pain per week;
  • Speak English or French; and
  • Have access to Internet.

Exclusion criteria:

  • Chiropractors will be excluded if they have already attended the webinar series or the self-management learning module. Prior webinar and learning module participants will have needed to register beforehand, which therefore provides the mechanism for confirming study ineligibility.

Patients

Inclusion criteria:

  • Attend a consenting chiropractor for non-specific neck pain of any duration;
  • Aged between 18 and 65, with a primary complaint of acute (<3 months) or chronic (>3 months) neck pain presenting as a new condition for treatment at the participating clinic;
  • Fluency in English or French to a level where they can read and understand the study information sheet, complete the consent form, and respond to the telephone-administered questionnaire. This will be assessed by the staff member of each chiropractor's team at the time of screening; and
  • Provide written informed consent.

Exclusion criteria:

  • Previous neck surgery;
  • Presence of Red flags;
  • Pregnancy; and
  • Chiropractic care received in the preceding 3 months for a complaint of neck pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483091


Locations
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Canada, Quebec
McGill University
Montreal, Quebec, Canada, H3G 1Y5
Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: André E Bussières, PhD McGill University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Andre Bussieres, Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT02483091     History of Changes
Other Study ID Numbers: G241013 R.E Strauss X-C 218563
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Andre Bussieres, McGill University:
Knowledge translation
Clinical practice guidelines
Multimodal care
Brief Action Planning
Feasibility outcomes

Additional relevant MeSH terms:
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Neck Pain
Somatoform Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders