Clinical Trial: RCT of Multimodal Physiotherapy for Acute / Sub-acute Cervical Radiculopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Trial of Multimodal Physiotherapy for Patients With Acute / Sub-acute Cervical Radiculopathy

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.

Detailed Summary:

Cervical radiculopathy (CR) has been defined by the North American Spine Society (NASS) as pain in a radicular pattern in one or both upper extremities related to compression and/or irritation of one or more cervical nerve roots, with signs and symptoms including varying degrees of sensory, motor, and reflex changes in addition to dysaesthesia and paraesthesia (Bono et al. 2011). CR is of particular clinical concern, given the higher levels of pain and disability associated with the presence of nerve-related arm pain resulting in higher healthcare costs for this cohort of people with neck pain (Rubinstein et al., 2007, Haldeman et al., 2008).

Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability for chronic (symptom duration > 3 months) CR (Boyles et al., 2011). No consensus on the optimum conservative management, or indeed optimal timing of such management, currently exists for acute / sub-acute cervical radiculopathy. The combined use of manual therapy with exercise for this cohort is now garnering interest; evident by the emergence of several randomised controlled trials (Nee et al., 2012, Langevin et al., 2015) involving treatment duration of 2-4 weeks. Langevin et al. (2015) demonstrated that using 2 varied programmes of manual therapy & exercise, led to similarly clinically significant improvements in pain and disability, particularly immediately after a 4 week intervention. However, without a 'no treatment' control group, natural recovery could not be excluded, confirming the need for adequate control groups in future trials (Langevin et al., 2015). The most recent Cochrane review of exercise for the treatment of mechanical neck disorders (MND) (including CR) concluded that there was low quality evidence to suggest a small pain reduction benefit with cervical stretch / strengthening / stabili
Sponsor: Royal College of Surgeons, Ireland

Current Primary Outcome:

• 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)
• 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)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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)
• 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).
• 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).
• 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.
• 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.
• 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.
• Short-form McGill Pain Questionnaire [ Time Frame: Baseline ]
  The Short-Form McGill Pain Questionnaire (SFMPQ) will also be used to assess the sensory and affective characteristics of pain (Melzack, 1987). It is a widely used assessment tool with well-established reliability and validity (Katz and Melzack, 2011). It will be used in this study in the secondary analysis of predictors to treatment response.
• Change from baseline in neck and arm pain levels (Numerical Pain Rating Scale) [ Time Frame: 12 weeks and 6 months ]
  NPRS described above
• Change from baseline in Neck Disability Index [ Time Frame: 12 weeks and 6 months ]
  NDI described above

Original Secondary Outcome:

• 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.
• 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)
• 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).
• 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).
• 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 smart phone application inclinometer.
• 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.
• 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.
• Short-form McGill Pain Questionnaire [ Time Frame: Baseline ]
  The Short-Form McGill Pain Questionnaire (SFMPQ) will also be used to assess the sensory and affective characteristics of pain (Melzack, 1987). It is a widely used assessment tool with well-established reliability and validity (Katz and Melzack, 2011). It will be used in this study in the secondary analysis of predictors to treatment response.
• Change from baseline in neck and arm pain levels (Numerical Pain Rating Scale) [ Time Frame: 12 weeks and 6 months ]
  NPRS described above
• Change from baseline in Neck Disability Index [ Time Frame: 12 weeks and 6 months ]
  NDI described above

Information By: Royal College of Surgeons, Ireland

Dates:
Date Received: May 5, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: June 28, 2016
Last Verified: May 2015