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RCT of Multimodal Physiotherapy for Acute / Sub-acute Cervical Radiculopathy (PACeR)

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ClinicalTrials.gov Identifier: NCT02449200
Recruitment Status : Recruiting
First Posted : May 20, 2015
Last Update Posted : March 28, 2019
Sponsor:
Collaborators:
Beaumont Hospital
EuroSpine - the Spine Society of Europe
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Brief Summary:
Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a research gap exists for optimal management in the first 12 weeks and short-term natural history of the condition is unclear, although thought to be favourable within the first 4 weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb unloading tape compared to advice to stay active, on disability, pain and other biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in self-reported disability and pain, compared to advice to stay active, in patients with acute / sub-acute cervical radiculopathy. A secondary study objective is to identify whether variables from the baseline examination, group allocation and aetiology confirmed by MRI can predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation, allocation concealment, blinded assessment and intention to treat analysis will be employed. Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability and their rating of recovery will also be recorded by telephone interview at 6 months. An internal pilot feasibility study will be undertaken in advance of the main study to test recruitment and retention strategies. Statistical analysis of differences between groups will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used to explore predictors of outcome.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Other: Multimodal physiotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Multimodal Physiotherapy for Patients With Acute / Sub-acute Cervical Radiculopathy
Actual Study Start Date : May 2015
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Multimodal physiotherapy group
4 week multimodal physiotherapy treatment programme provided by an experienced musculoskeletal physiotherapist
Other: Multimodal physiotherapy
Manual therapy, exercise and neural unloading tape provided twice weekly over 4 weeks by an experienced musculoskeletal physiotherapist

No Intervention: Advice to stay active group
Advice to stay active and continue use of prescribed medication as appropriate, via weekly phone calls from a physiotherapist over a 4 week period.



Primary Outcome Measures :
  1. Change from baseline in neck and arm pain (Numerical Pain Rating Scale) [ Time Frame: 4 weeks ]
    Neck and arm pain levels measured with the Numerical Pain Rating Scale for current, best and worst pain levels over last 24 hours (Jensen et al 1994)

  2. Change from baseline in Neck Disability Index [ Time Frame: 4 weeks ]
    Disability resulting from the cervical radiculopathy measured with the Neck Disability Index (Vernon and Mior 1991)


Secondary Outcome Measures :
  1. Cervical range of motion (ROM) measured with a CROM 3 device [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Cervical ROM measured with a CROM 3 device (Performance Attainment Associates, USA). Flexion, extension, bilateral sideflexion and rotation will be measured.

  2. SF-12 version 2 Health Survey [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Quality of Life using the SF-12 version 2 Health Survey (Cheak-Zamora et al, 2009)

  3. Pressure Pain Thresholds measured with a SenseBox pressure algometer [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Pressure pain thresholds measured with a SenseBox pressure algometer (Somedic, Sweden) at standardised sites on both hands at site of maximal pain and anterior tibia as a remote site (Walton et al 2011).

  4. Hospital Anxiety Depression Scale [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Hospital Anxiety Depression Scale (HADS), a validated scale that assesses non-somatic symptoms of anxiety and depression (Zigmond and Snaith, 1983).

  5. Upper Limb Neurodynamic test 1 [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Upper limb neurodynamic test 1 is a validated pain provocation test of nervous tissue directly assesses nerve mechanosensitivity (Elvey, 1994 and Wainner and Gill, 2000). It is considered positive if it reproduces arm pain with differentiation tests. Degrees of elbow flexion at point of symptom onset, measured with a universal goniometer.

  6. Fear Avoidance Belief Questionnaire (Neck) [ Time Frame: Baseline, 4 weeks and 12 weeks ]
    Fear Avoidance Belief Questionnaire (FABQ). The FABQ was initially established to measure how patients' beliefs about physical activity and work affected their low back pain (Waddell et al., 1993). Landers et al. (2008) have since established that the FABQ can predict neck pain patients who may develop prolonged disability.

  7. painDETECT Questionnaire [ Time Frame: Baseline ]
    PainDETECT is a self-report questionnaire that was designed to detect neuropathic pain components in adult patients with low back pain (Freynhagen et al., 2006). It has since been used in a cervical radiculopathy cohort and will be used in this study in the secondary analysis of predictors to treatment response.

  8. Change from baseline in neck and arm pain levels (Numerical Pain Rating Scale) [ Time Frame: 12 weeks and 6 months ]
    NPRS described above

  9. Change from baseline in Neck Disability Index [ Time Frame: 12 weeks and 6 months ]
    NDI described above



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for CR diagnosis on a clinical prediction rule (CPR) by demonstrating positive responses to at least 3 of the following 4 clinical tests: Spurling's Test, Upper Limb Neural Tissue Provocation Test 1 (ULNT 1), Cervical Distraction Test, and less than 60° of cervical rotation on the symptomatic side (Wainner et al., 2003).
  • Complaints of neck / periscapular pain, in addition to radicular pain, paraesthesia or numbness in the upper limb; aggravated by neck posture or movement (Thoomes et al., 2012).
  • Symptom duration must be greater than 2 weeks and less than 3 months.
  • Mean of Numerical Pain Rating Scale (NPRS) scores for both neck and arm pain must be ≥ 3/10.
  • Fluent in spoken and written English.
  • Willing to give informed consent.

Exclusion Criteria:

  • Previous physiotherapy / manual treatment to cervical spine within past 6 months.
  • Previous epidural injection since the onset of current symptoms.
  • Prior surgery to the cervicothoracic spine or currently symptomatic upper limb.
  • Current symptoms & signs of bilateral radiculopathy.
  • Myotomal paresis less than 4 / 5 on Medical Research Council Scale in affected upper limb.
  • Signs and symptoms suggestive of Cervical Spondylotic Myelopathy (CSM): bilateral paraesthesia, hyperreflexia, positive Babinski reflex and spasticity.
  • Diagnosis of any generalised neurological disorder e.g. multiple sclerosis.
  • Concurrent peripheral neuropathy affecting either upper limb e.g. carpal tunnel syndrome, thoracic outlet syndrome.
  • Medical red flags suggestive of serious pathology such as neoplastic conditions, upper cervical ligamentous instability, vertebral artery insufficiency and inflammatory or systemic disease (Childs et al., 2004).
  • Diagnosis of fibromyalgia.
  • Psychiatric diagnosis in past 6 months.
  • Ongoing litigation relating to cervical symptoms.

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): NCT02449200


Contacts
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Contact: Louise Keating, MPhtySt 353 1 4022259 lkeating@rcsi.ie
Contact: Dara Meldrum, PhD 353 1 4022368 meldrumd@tcd.ie

Locations
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Ireland
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Prof. Ciaran Bolger, PhD       cbolger@rcsi.ie   
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Beaumont Hospital
EuroSpine - the Spine Society of Europe
Investigators
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Principal Investigator: Louise Keating, MPhtySt Royal College of Surgeons in Ireland

Additional Information:
Publications:
Jull, G., Sterling, M., Falla, D., Treleaven, J. & O'Leary, S. 2008. Whiplash, Headache and Neck Pain. Research-based directions for physical therapists., Churchill Livingstone.

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02449200     History of Changes
Other Study ID Numbers: GR 14-0917
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Royal College of Surgeons, Ireland:
cervical radiculopathy
exercise
manual therapy
tape

Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases