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Effectiveness of Physiotherapy Following PRP for Chronic Whiplash

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ClinicalTrials.gov Identifier: NCT03949959
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief 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.


Condition or disease Intervention/treatment Phase
Whiplash Injuries Neck Injuries Platelet Rich Plasma Other: Multimodal physiotherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A Single Case Experimental Design (SCED) will be used to evaluate the intervention. Participants act as their own controls, and thus are exposed to both the treatment and control conditions. The study will be conducted and reported according to the Singe Case Reporting guidelines in BEhavioural Interventions (SCRIBE). A randomised, concurrent, multiple-baseline A1 (baseline control) - B (intervention)-A2 (follow-up withdrawal) design will be used to meet the methodological recommendations for SCEDs. Participants will be randomly allocated to a 5, 8 or 11 day baseline period during which they will undertake their usual activities. The baseline phase will be followed by a 6-week intervention period during which participants will participate in 10, one hour sessions with an experienced post-graduate trained physiotherapist. The intervention phase will be followed by a 12-week follow-up phase where participants will have no contact with the intervention personnel.
Masking: Single (Participant)
Masking Description: Participant is not made aware of intervention arm - treat as usual or physiotherapy. Radiologist providing PRP tells participant to refrain from treatment for 6-weeks, or to immediately commence physiotherapy.
Primary Purpose: Treatment
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).
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Physiotherapy (PRPt)
The 6-week exercise program (2 sessions in each of weeks 1-4 and 1 session in each of weeks 5 and 6) will comprise specific individually-tailored exercises to improve the movement and control of the neck and shoulder girdle. The exercises will be of a low load nature and designed to be pain free. At the same time, the physiotherapist will provide pragmatic multimodal physiotherapy to facilitate ability to pursue exercises and guide the participant's return to normal activities. This specific treatment program has been described in detail (Jull et al., 2008; Ritchie et al., 2015b) and focuses on activating and improving the coordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks. Participants will also perform the exercises at home, once per day. Written and illustrated exercise instructions will be provided. The exercise program follows Australian guidelines for the management of chronic whiplash (TRACsa, 2008).
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.

No Intervention: Wait and See (PRPu)

Individuals randomized to usual care will be provided with an advice booklet Whiplash Injury Recovery: A Self Help Guide (MAIC, Qld, 2nd edition). It provides information about whiplash; assurance about prognosis; advice to stay active and resume working as well as information on correct posture; pictorial descriptions of specific exercises for the neck and upper limbs and information on resuming functional daily activities. The booklet is based on the recommendations of the current Australian Guidelines for Whiplash Management (SIRA, 2014).

Usual care involves a 'wait and see' approach (in combination with provision of home exercises) and will include weekly review appointments with a medical doctor, primarily to review the information in the booklet and progress the 'general' exercises and activity recommendations within the booklet. No hands-on physiotherapy will be provided. Education regarding PRP and associated healing cycles will also be provided during this time period.




Primary Outcome Measures :
  1. Pain, Enjoyment of Life and General Activity (PEG) [ 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).

  2. Self-efficacy whilst performing daily activities in chronic WAD. [ 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.


Secondary Outcome Measures :
  1. Neck Disability Index (NDI) [ 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.

  2. Patient Global Impression of Change (-3 to +3 scale) [ 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

  3. Depression & Anxiety Stress Scales (DASS-21) [ 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).

  4. The Pain Catastrophizing Scale (PCS) [ 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).

  5. Medical Outcomes Survey Short Form (SF-12) [ 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03949959


Contacts
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Contact: Ashley Smith, PhD 825-994-2294 ashley.smith@griffith.edu.au

Locations
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Canada, Alberta
Evidence Sport & Spinal Therapy Recruiting
Calgary, Alberta, Canada, T3B 4N2
Contact: Kim Phair    403 210 9969    kim.phair@evidencesportandspinal.com   
Sub-Investigator: Geoff Schneider, PhD         
Sub-Investigator: Arun Gupta, MD         
Sub-Investigator: Jacqueline Stone, MD         
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Ashley Smith, PhD University of Calgary
Additional Information:
Publications:
Lord, S., McDonald, G., & Bogduk, N. (1998). Percutaneous Radiofrequency Neurotomy of the Cervical Medial Branches: A Validated Treatment for Cervical Zygapophysial Joint Pain. Neurosurgery Quarterly, 8(4), 288-308
Lovibond, S., & Lovibond, P. (1995). Manual for the Depression Anxiety Stress Scales (2nd ed.). Sydney: Psychology Foundation.
Nikles, J. (2015). What are N-of-1 Trials? In J. Nikles & G. Mitchell (Eds.), The Essential Guide to N-of-1 Trials in Health (pp. 9-17). Dordrecht: Springer Netherlands.
Parker, R. I., Vannest, K. J., & Brown, L. (2009). The improvement rate difference for single case research. Exceptional Children, 75, 135-150
SIRA - Guidelines for the management of acute whiplash associated disorders - for health professionals. (2014).
Sullivan, M., Bishop, S., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychol Assess, 7, 524-532
Van den Noortgate, W., & Onghena, P. (2007). The aggregation of single-case results using hierarchical linear models. The Behavior Analyst Today, 8(2), 196-209
TRACsa - Clinical guidelines for best practice management of acute and chronic whiplash-associated disorders (2008).
Jull, G., Sterling, M., Falla, D., et al. (2008). Whiplash, Headache and Neck Pain (1 ed.): Churchill Livingstone.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03949959    
Other Study ID Numbers: REB18-0724
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Physiotherapy
Additional relevant MeSH terms:
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Wounds and Injuries
Whiplash Injuries
Neck Injuries