About this trial
Chronic nonspecific neck pain is a prevalent and recurrent condition frequently characterised by persistent impairments in cervical-scapular neuromuscular function. Deep cervical flexor motor-control deficits and reduced upper trapezius endurance represent two clinically relevant but distinct manifestations of neuromuscular dysfunction. Deep cervical flexor motor-control exercise targets cervical segmental control and movement coordination, while upper trapezius endurance exercise targets at the mechanical capacity of the cervical-scapular system. Although both exercise approaches have demonstrated clinical benefit when used independently, it remains unknown whether combining these two exercises as compared to single-exercise approach would provide additional or synergistic effects on the clinical recovery for individuals with chronic nonspecific neck pain.
This three-arm comparative randomised controlled trial will investigate a 5-week hybrid programme combining deep cervical flexor motor-control and upper trapezius endurance exercise as compared to their single-exercise comparator programme (i.e., deep cervical flexor motor-control exercise alone or upper trapezius endurance exercise alone) in managing the clinical recovery of adults with chronic nonspecific neck pain. Two hundred and ten participants will be randomly allocated to one of the three groups (70 participants per group) upon the completion of the baseline evaluation of the study outcomes. All programmes will use standardised exercise procedures, individualised progression, supervised instruction, and structured home exercise format. Study outcomes will be assessed at baseline, immediately after the 5-week intervention, and 6 months after programme completion in order to enable the evaluation of the exercise programme effectiveness at immediate and longer-term.
The primary objective is to determine the effectiveness of hybrid exercise programme as compared to the two single-component exercise programmes on the primary outcomes namely neck pain intensity, neck-related disability and upper-extremity physical function, and general health status (as secondary outcome) at immediate (change between pre- and post-programme of the 5-week programme) and longer-term reassessments (change between pre-programme and 6-month after the 5-week programme).
The secondary objective aims to study the mechanisms underpinning the observed effectiveness produced by the exercise programmes by evaluating the changes in neuromuscular and muscle-mechanical function, including deep cervical flexor performance, upper trapezius endurance, joint position error, muscle mechanical properties and vascularity, together with changes in pain sensitivity, exercise-induced hypoalgesia, and pain-related and exercise-specific self-efficacy, at both the immediate and longer-term reassessments.
Findings this trial will provide evidence if differential effectiveness on clinical outcomes present when rehabilitating adults with chronic nonspecific neck pain using combined and single-component exercise approaches. Furthermore, findings of the mechanism-mediation analysis will provide a scientific basis for more targeted, mechanism-informed exercise prescription for chronic nonspecific neck pain. Overall, results to be obtained from this trial will help refine the therapeutic exercise prescription and promote the outcome recovery for conservative management of this highly prevalent spinal condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults aged 18-50 years
unilateral CNSNP of more than 3 months' duration with mechanical nature (neck pain provoked or aggravated by cervical posture or movement)
baseline neck pain ≥3/10 on Numerical Pain Rating Scale (NPRS)
baseline functional disability ≤25/50 on Neck Disability Index (NDI)
Disqualifiers
neck pain caused by trauma or with a specific diagnosis (including radiculopathy, disc herniation, or spinal stenosis, or if neurological deficits or congenital cervical deformity)
history of previous surgery of the cervical or thoracic spine or shoulder
marked restriction of cervical mobility verified by extension <30° or rotation <60° (Cleland et al., 2010; Wainner et al., 2003)
inability to achieve full shoulder elevation required for the prescribed exercise
Trial design
Parallel
Treatments tested in this trial
Hybrid exercise group
Other interventionHybrid exercise programme included 1) deep cervical flexor motor-control and 2) upper trapezius endurance exercise for five consecutive weeks. The low-load craniocervical flexion exercise (for facilitation of the activation of longus capitis and longus colli) will be performed in supine crook lying position with the participants' head and neck in a neutral position. Training commences at the participant's baseline craniocervical flexion test endurance score (20mmHg to 30mmHg) for 10 repetiation of 10-second hold time using the pressure biofeedback unit, under the supervision by a physiotherapist, who is independent from study outcome assessment. Upper trapezius endurance exercise will be performed through overhead shrugging with an elastic band while maintaining the neutral head and neck in sitting. Three set of 15 repeitations with 1-min rest between sets, at the exercise level standardised to a perceived exertion of 7/10 on the Borg Category Ratio 10 scale.
Motor control exercise group
Other interventionDeep cervical flexor motor-control will be performed by participants who are allocated to this exercise group. The same low-load craniocervical flexion exercise (for facilitation of the activation of longus capitis and longus colli) will be performed in supine crook lying position with the participants' head and neck in a neutral position. Training commences at the participant's baseline craniocervical flexion test endurance score (20mmHg to 30mmHg) for 10 repetiation of 10-second hold time using the pressure biofeedback unit, under the supervision by a physiotherapist, who is independent from study outcome assessment.
Endurance exercise group
Other interventionUpper trapezius endurance exercise (the same exercise component described in hybrid exercise programme) will be performed through overhead shrugging with an elastic band while maintaining the neutral head and neck in sitting. Three set of 15 repeitations with 1-min rest between sets, at the exercise level standardised to a perceived exertion of 7/10 on the Borg Category Ratio 10 scale.
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity
Pain intensity of the neck region measured by the Numeric Pain Raing Scale 0-10
Functional disability
Functional disabilty related to chronic nonspecific neck pain will be measured by 1. Neck Disabilty Index (NDI) and 2. Disability of Arm, Shoulder and Hand Qestionnaire (DASH)
Secondary outcomes
General health status
Short-Form 12 is used to assess the self-reported general health status of the participants.
Other outcomes
Self-Efficacy
Self-reported 1. Pain Self-Efficacy (measured by the Pain Self-Efficacy Questionnaire) (Lim et al., 2007) and 2. Exercise Self-Efficacy (measured by the Self-Efficacy for Exercise Scale (Wong et al., 2018).
Pain sensitivity
Measures of pain senstivity assessed by pressure pain threshold and pincprick-induced temporal summation of pain, over the cervical extensors and upper trapezius muscles. Pressure pain threshold indexes pressure pain sensitivity, whereas temporal summation of pain quantifies the facilitation of pain responses to repeated noxious stimulation.
Exercise-induced hypoalgesia index
EIH is assessed immediately before and after the assigned exercise intervention within the same assessment session using the NPRS and PPT procedures described above. The magnitude of EIH is quantified using an EIH index based on the pre-to-post change in NPRS and PPT, calculated as pre-exercise NPRS - post-exercise NPRS and post-exercise PPT - pre-exercise PPT, respectively. Positive values indicate a hypoalgesic response (van Leer et al., 2017). Relative changes are additionally calculated as the corresponding change divided by the pre-exercise value × 100%.
Mechanical properties of the muscles (cervical extensors and upper trapezius)
Mechanical properties of the cervical extensors and upper trapeizus will be assessed using the myotonPRO device (for muscle tone, stiffness and elasticity) and the shearwave elastography (for stiffness).
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
University of Birmingham
Collaborator
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
Chinese University of Hong Kong
Collaborator
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