Effectiveness of Physiotherapy Following PRP for Chronic Whiplash

November 2, 2021 updated by: University of Calgary

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E2P5
        • Vivo Cura Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 11 days + 12 weeks
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
Up to 11 days + 12 weeks
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).
Up to 11 days + 12 weeks
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).
Up to 11 days + 12 weeks
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).
Up to 11 days + 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Ashley Smith, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

October 18, 2021

Study Completion (Actual)

October 18, 2021

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB18-0724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Whiplash Injuries

Clinical Trials on Multimodal physiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe