Vivo Cura Health
Calgary, Alberta, T2E2P5, Canada
NCT Number: NCT03949959
The investigators will explore a standardized and previously published evidence-based conservative multimodal physiotherapy treatment fulfilling clinical practice guidelines in individuals with chronic whiplash-associated disorders (WAD) with facet-mediated pain (appropriate response to dual medial branch blocks) undergoing cervical facet joint Plasma-Rich Platelet (PRPt) and compare health outcomes to individuals' undergoing cervical facet joint PRP with usual care (PRPu), which consists of advice, supervised home exercise and pharmacological management for treatment of residual pain. To be clear, the investigators are not investigating the efficacy or effectiveness of cervical facet joint PRP - these individuals have already consented to proceed with PRP treatment. The investigators are evaluating the role of adjuvant conservative multimodal physiotherapy treatment. It must be noted that these patients have previously failed to respond to conservative physiotherapy. The investigators will use a design which is quite novel in physiotherapy, Single Case Experimental Designs (SCEDs). In contrast to an experimental group design in which one group is compared with another, participants in single-subject research provide their own control data for the purpose of comparison in a within-subject rather than a between-subjects design. SCEDs provide a method to determine response and benefit for every individual patient.
Therefore, the investigators will assess effectiveness of conservative multimodal physiotherapy for chronic WAD with facet-mediated pain undergoing cervical facet joint PRP, using patients as their own control, in a multiple baseline design.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Calgary, Alberta, T2E2P5, Canada
This will be a single case with randomized multiple baseline experimental design with enrolment of 3 patients undergoing PRPt, and 3 patients undergoing PRPu following PRP. There will be a variable length baseline (A1) and then a staggered start to provide internal validity - one patient starting at 5 days (post-PRP), one at 8 (post-PRP) and one at 11 days post-PRP, randomly allocated. This study will utilise an A1-B-A2 design: a baseline (A1 no intervention); intervention phase (B); and a no intervention (A2 follow up).
Primary outcome measures will be collected daily during this time period. The baseline phase will be followed by a 6-week intervention period (B). Participants will have 10 one hour sessions over a 6-week period. The intervention will be delivered by an experienced physiotherapist with postgraduate qualifications. During the intervention period, once or twice per week the daily collection of the primary outcome measures will coincide with the delivery of each intervention session. The intervention phase will be followed by a 12-week follow-up phase (A2) where participants will have no contact with the intervention personnel. This follow-up phase is implemented in order to determine the possible duration of improvement post intervention. All outcome measures will be collected at the completion of this 12-week follow-up period.
Secondary outcome measures for generalisation purposes will be collected prior to commencing PRP, at the end of the intervention period (which coincides with the commencement of the no-intervention period), and at the end of the no-intervention period; totalling 3 sampling points throughout the study duration.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undertake their usual activities for the 5, 8 or 11 day baseline period following PRP. Participants will begin the 6 week intervention period following this period during which time they will participate in 10 sessions with an experienced postgraduate physiotherapist. After these 6-weeks, participants will have no contact with intervention personnel during the 6-week follow-up period.
Time frame: 12 weeks
PEG measures average neck pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) on the continuous numeric rating scale (NRS) of 0 to 10 during the last 24 hours (Krebs et al., 2009).
Time frame: 12 weeks
This question will ask participants to identify "how confident are you in your ability to perform your daily tasks in the presence of your neck pain or disability?" with 1 indicating not at all confident; 2 indicating a little confident 3 indicating moderately confident; 4 very confident and 5 indicating extremely confident.
Time frame: Up to 11 days + 12 weeks
The NDI is a reliable and responsive measure of neck pain related disability, validated for use with individuals following whiplash injury (Vernon & Mior, 1991). The 10-item questionnaire includes activities of daily living that may be affected by neck pain. A percentage score will be calculated from the 0-5 Likert scored response to each question.
Time frame: Up to 11 days + 12 weeks
This is a 7 point scale that requires the clinician to assess how much the patient's condition has improved or worsened relative to a baseline state at the beginning of the intervention. +/- 3 relates to Very Much Improved/Worse; +/- 2 to Much Improved/Worse; +/-1 Minimally Improved/Worse
Time frame: Up to 11 days + 12 weeks
The DASS-21 consists of 21 questions, each reflecting a negative emotional symptom. It consists of 3 subscales: Depressive, Anxiety and Stress symptoms. Each question is Likert scored (0-3). The sum of the relevant 7 items for each subscale constitute the participants' scores for each subscale (Lovibond & Lovibond, 1995).
Time frame: Up to 11 days + 12 weeks
This scale is a 13-item scale to evaluate catastrophic thinking about pain. It is Likert scored (1-4).
Time frame: Up to 11 days + 12 weeks
This survey measures health related quality of life. The SF-12 contains 12 questions relating to the domains physical functioning; role limitations because of physical health problems; bodily pain; general health perceptions; vitality (energy/fatigue); social functioning; role limitations because of emotional problems; and general mental health (psychological distress and psychological well-being). Physical and mental component summary scores are computed using the 12 questions and range from 0 (lowest level of health) to 100 (highest level of health) (Ware et al, 1996).
University of Calgary
Other
Effectiveness of Conservative Multimodal Physiotherapy in Chronic Whiplash-associated Disorders With Facet-mediated Pain Undergoing Platelet Rich Plasma (PRP) Treatment: a Series of Single Case Experimental Designs (SCEDs).
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