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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Radiculopathy||Other: Multimodal physiotherapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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)
- 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.
- 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
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
|Contact: Louise Keating, MPhtySt||353 1 email@example.com|
|Contact: Dara Meldrum, PhD||353 1 firstname.lastname@example.org|
|Dublin, Ireland, 9|
|Contact: Prof. Ciaran Bolger, PhD email@example.com|
|Principal Investigator:||Louise Keating, MPhtySt||Royal College of Surgeons in Ireland|