Effectiveness of Physiotherapy Following PRP for Chronic Whiplash

Whiplash Injuries Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949959
• Other study ID #: REB18-0724
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: October 18, 2021

Study information

• Verified date: October 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Individuals with Grade II Whiplash Associated Disorder with > 80% relief of familiar neck pain after dual medial branch blocks

• > 12 weeks since injury and failed to respond to previous (> 6 weeks) conservative treatment

• Neck pain on numerical pain rating scale = 4/10

• Neck Disability Index > 28%

Exclusion Criteria:

• Presence of dizziness symptoms

• Known or suspected serious spinal pathology (e.g. metastatic disease of the spine);

• Confirmed fracture or dislocation at time of injury (i.e., WAD Grade IV)

• Nerve root compromise (i.e., WAD Grade III)

• Spinal surgery in the past 12 months; and

• History of any mental health conditions such as bipolar disorder, psychosis, schizophrenia, anxiety, PTSD or severe depression

• Inability to stop taking anti-inflammatory medications for 3-days prior to, or 10-days following PRP

• Unable to understand +/- complete validated questionnaire items in English

Related Conditions & MeSH terms

• Neck Injuries
• Platelet Rich Plasma
• Whiplash Injuries
• Wounds and Injuries

Intervention

Other:
• Multimodal physiotherapy
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.

Locations

Country	Name	City	State
Canada	Vivo Cura Health	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Enjoyment of Life and General Activity (PEG)	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).	12 weeks
Primary	Self-efficacy whilst performing daily activities in chronic WAD.	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.	12 weeks
Secondary	Neck Disability Index (NDI)	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.	Up to 11 days + 12 weeks
Secondary	Patient Global Impression of Change (-3 to +3 scale)	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	Up to 11 days + 12 weeks
Secondary	Depression & Anxiety Stress Scales (DASS-21)	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).	Up to 11 days + 12 weeks
Secondary	The Pain Catastrophizing Scale (PCS)	This scale is a 13-item scale to evaluate catastrophic thinking about pain. It is Likert scored (1-4).	Up to 11 days + 12 weeks
Secondary	Medical Outcomes Survey Short Form (SF-12)	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).	Up to 11 days + 12 weeks

External Links

•   Insurance Bureau of Canada. Facts 2017.
•   Motor Accident Authority Annual Report 2014-5.
•   Oxford Centre for Evidence-Based Medicine Levels of Evidence Working Group(2011). The Oxford 2011 Levels of Evidence Table (Introduction)