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临床试验/NCT07837414
NCT07837414尚未招募不适用

Powering Exercise-induced Hypoalgesia and Functional Recovery in Chronic Nonspecific Neck Pain by Hybrid Muscle Conditioning: a Comparative Effectiveness Randomised Controlled Trial With Mechanistic Analysis

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2026年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
210
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

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.

详细描述

Study Summary This randomised controlled trial evaluates whether a 5-week hybrid exercise programme combining deep cervical flexor (DCF) motor-control training and upper trapezius (UT) endurance training yields greater improvements in neck pain, disability, and upper-extremity function than either single-exercise programme alone (Objective 1). Two hundred and ten adults with chronic non-specific neck pain will be randomised into three groups and followed for 6 months. Mechanistic domains (pain sensitivity, exercise-induced hypoalgesia, muscle mechanical properties, neuromuscular performance, joint position error, and self-efficacy) will be examined as potential mediators of clinical change (Objective 2).

Study Design

  • Type: Interventional, randomised controlled trial
  • Design: Three-arm parallel-group comparative effectiveness trial
  • Intervention Duration: 5 weeks
  • Follow-up: 6 months
  • Masking: Outcome assessors blinded
  • Allocation: Computer-generated minimisation for intervention randomisation
  • Primary Purpose: Treatment
  • Study Site: Musculoskeletal Physiotherapy Classroom (Room GH014), The Hong Kong Polytechnic University

Participants

Target Population and Recruitment Adults aged 18-50 years with unilateral chronic non-specific neck pain (CNSNP) lasting >3 months. Convenience sampling from the local community and from Prince of Wales Hospital. Eligibility screening conducted by physiotherapists with ≥5 years of musculoskeletal experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)
  • •baseline funcctional diability ≤60/100 on Disabilities of the Arm, Shoulder and Hand (DASH)
  • •impaired deep cervical flexor performance verified by <26 mmHg on craniocervical flexion test (CCFT) activation score (Jull et al., 2004)
  • •positive scapular reposition test verified by an immediate reduction in pain or improvement in cervical range of motion during manual scapular repositioning (Van Dillen et al., 2007; Wannaprom et al., 2021)

排除标准

  • •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
  • •BMI ≥25 kg/m²
  • •comoborities orthopaedic, neurological, or systemic conditions
  • •high fear-avoidance beliefs verified by Tampa Scale for Kinesiophobia score ≥37 (Vlaeyen and Linton, 2000); psychological distress (SF-12 Mental Component Summary score ≤40) (Yu et al., 2015)
  • •regular use of analgesics, muscle relaxants, or vasoactive medications
  • •dizziness or vertigo suggestive of vestibular dysfunction or vertebrobasilar insufficiency
  • •any contraindications to electrical stimulation for muscle endurance index measurement (any mental or neural implant, seizure)

研究组 & 干预措施

Hybrid exercise group

Experimental

Deep cervical flexor motor control exercise combined with upper trapezius endurance exercise (named as Hybrid group and serves as the experimental group for comparison of its effectiveness to the two single-exercise comparator groups)

干预措施: Hybrid exercise group (Other)

Motor control exercise group

Active Comparator

Deep cervical flexor motor control exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)

干预措施: Motor control exercise group (Other)

Endurance exercise group

Active Comparator

Upper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)

干预措施: Endurance exercise group (Other)

结局指标

主要结局

Pain intensity

时间窗: At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

Pain intensity of the neck region measured by the Numeric Pain Raing Scale 0-10

Functional disability

时间窗: At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

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)

次要结局

  • General health status(At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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