Effectiveness of Physiotherapy Following PRP for Chronic Whiplash

NCT03949959 | Completed

• 1 other identifier: REB18-0724
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries; Neck Injuries; Platelet Rich Plasma

Keywords

Physiotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Neck Disability Index (NDI)

  Up to 11 days + 12 weeks

• Patient Global Impression of Change (-3 to +3 scale)

  Up to 11 days + 12 weeks

• Depression & Anxiety Stress Scales (DASS-21)

  Up to 11 days + 12 weeks

• The Pain Catastrophizing Scale (PCS)

  Up to 11 days + 12 weeks

• Medical Outcomes Survey Short Form (SF-12)

  Up to 11 days + 12 weeks

Study Arms (2)

Physiotherapy (PRPt)

EXPERIMENTAL

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

Wait and See (PRPu)

NO INTERVENTION

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.

Interventions

Multimodal physiotherapy OTHER

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.

Physiotherapy (PRPt)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Vivo Cura Health

Calgary, Alberta, T2E2P5, Canada

Location

Related Publications (51)

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Related Links

• Oxford Centre for Evidence-Based Medicine Levels of Evidence Working Group(2011). The Oxford 2011 Levels of Evidence Table (Introduction)

MeSH Terms

Conditions

Whiplash Injuries; Neck Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ashley Smith, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 14, 2019
• Study Start: March 4, 2019
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)