Cervical radiculopathy: Study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044]

Abstract

BackgroundCervical radiculopathy is a common form of neck pain and has been shown to lead to severe disability. Clinical rehabilitation approaches for cervical radiculopathies commonly include exercise and manual therapy interventions targeting the opening of intervertebral foramen, but evidence regarding their effectiveness is scarce. The primary objective of this randomised clinical trial is to compare, in terms of pain and disability, a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program, for patients presenting acute or subacute cervical radiculopathies. The hypothesis is that the rehabilitation program targeting the opening of intervertebral foramen will be significantly more effective in reducing pain and disability than the conventional rehabilitation program.Methods/DesignThis study is a double-blind (participants and evaluators blinded) randomised clinical trial that will allow the comparison of patients with a cervical radiculopathy randomly assigned to one of two groups: one group will receive a 4-week rehabilitation program targeting the opening of intervertebral foramen, and the second group will receive a 4-week conventional rehabilitation program. Thirty-six subjects with cervical radiculopathy will be recruited from participating medical and physiotherapy clinics and will be evaluated at baseline, at the end of the 4-week program and four weeks following the end of the program. The primary outcome measure will be the validated Neck Disability Index questionnaire. Secondary outcome measures will include the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients' perceived global rating of change. During the 4-week rehabilitation program, each participant will take part in eight physiotherapy treatment sessions (2 session/week) and will perform a home exercise program. A mixed-model, 2-way ANOVA will be used to analyze the effects of the rehabilitation programs.DiscussionControl trials are needed to define ideal intervention approaches in rehabilitation for this population. This randomised clinical trial will be the first study that directly compares a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program for patients with cervical radiculopathy. The results of this study may help to establish best clinical practice guidelines for this patient population.Trial RegistrationClinicalTrials.gov: NCT01500044

Home exercises for neck pain: A Delphi survey

“…Thirty articles were included and analyzed, and the information was synthesized ([Ahn et al., 2015; Alagha, 2015; Alpayci & Ilter, 2017; Andias et al., 2018; Boyoung et al., 2016; Bronfort et al., 2012; Bunketorp et al., 2006; Chan et al., 2015; Cramer et al., 2013; Dellve et al., 2011; Dusunceli et al., 2009; Galindez‐Ibarbengoetxea et al., 2017; Gallego Izquierdo et al., 2016; Gelecek & Akkan, 2017; Hakkinen et al., 2008; Iversen et al., 2018; Jakobsen et al., 2014; Karlsson et al., 2014; Langevin et al., 2012; Lauche et al., 2017; Lee et al., 2016a; Martel et al., 2011; Nazari et al., 2018; Nikander et al., 2006; Soderlund et al., 2000; Taimela et al., 2000; Takasaki & Herbowy, 2016; Vikne et al., 2007; Yesil et al., 2018; Ylinen et al., 2007] —Table ). The protocol was developed based on the principles of treatment with the strongest available evidence.…”

A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol

“…Adults with single-level cervical radiculopathy of less than 12 weeks duration are eligible to participate. Inclusion & exclusion criteria are adapted from studies of similar cohorts [26, 27].…”

“…1), as decided by the treating physiotherapist from a best-practice physiotherapy treatment manual. Previous RCTs investigating physiotherapy for nerve-related arm pain or cervical radiculopathy have involved 2 to 6 week programmes [27, 31, 32]. All participants receive lateral glide mobilisation [33] to the appropriate segmental level, applied using a treatment algorithm modified from Nee et al [26].…”

The shift of segmental contribution ratio in patients with herniated disc during cervical lateral bending

“…Forty-six diagnosed C4/5 and/or C5/6 disc-herniated patients with neck, shoulder blades or radiating arm symptoms (such as: pain, sensory disorder, reflex abnormalities, and motor weakness) within recent 3 months were recruited from the Department of the Physical Medicine and Rehabilitation in a medical center to enroll in this study. The patients were excluded if she/he had (1) history of cervical surgery, such as disc replacement, bone fusion, and discectomy, (2) significant potential for cord injury, such as cord impingement from a large disk herniation, (3) advanced cervical spondylosis, (4) severe spinal stenosis, (5) inflammatory arthritic disorders (ankylosing spondylitis, rheumatoid arthritis), (6) severe spinal instability, and (7) pregnancy [ 6 , 10 , 18 ]. The age of the participants ranged from 20 to 45 years and clinical characteristics of the patients were documented.…”