Protocol for a Pragmatic, Randomized Controlled, Parallel-group Superiority Trial Comparing the Effectiveness of Mechanical Diagnosis and Therapy Versus Generalized Exercise for Reducing Pain in Surgeons With Chronic Spinal Pain and a Directional Preference
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Average spinal pain intensity
研究概览
简要总结
Surgeons frequently experience chronic spinal pain due to prolonged static postures and repetitive movements during surgical procedures. Exercise therapy is recommended, but it is unclear which type of exercise is most effective for this population.
This randomized clinical trial will compare Mechanical Diagnosis and Therapy (MDT), also known as the McKenzie Method, with a structured program of generalized exercise in surgeons with chronic spinal pain who demonstrate a directional preference (i.e., movement in a specific direction that reduces symptoms).
Participants will be randomly assigned to one of the two interventions and followed for 26 weeks. The primary outcome is spinal pain intensity at 12 weeks measured on a 0-10 scale. Secondary outcomes include function, quality of life, and psychological factors.
This pragmatic trial is conducted in outpatient physiotherapy settings and aims to determine whether an individualized exercise approach (MDT) is more effective than generalized exercise in this occupational group.
详细描述
Chronic spinal pain is common among surgeons due to prolonged static postures and physical demands during surgical procedures. Exercise therapy is recommended as first-line treatment, but the relative effectiveness of different exercise approaches remains unclear.
This study is a pragmatic, randomized, parallel-group trial comparing Mechanical Diagnosis and Therapy (MDT) with generalized exercise in surgeons with chronic spinal pain who demonstrate a directional preference. MDT is a classification-based approach that prescribes exercises based on symptom response to repeated movements, whereas generalized exercise includes strengthening, stretching, and endurance training without targeting directional preference.
Participants will be recruited from surgical specialties in Denmark and randomized 1:1 to MDT or generalized exercise. Interventions will be delivered by physiotherapists in outpatient clinical settings.
The primary objective is to compare the effect of MDT versus generalized exercise on spinal pain intensity at 12 weeks. Secondary objectives include effects on function, quality of life, and psychological factors.
The trial is designed to reflect routine clinical practice and to evaluate whether an individualized, classification-based exercise approach provides additional benefit compared with a guideline-based generalized exercise program.
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
- None
盲法说明
Outcome assessors and statisticians will remain blinded to group allocation.
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-70 years
- •Currently working as a resident, fellow, or attending surgeon
- •Chronic spinal pain (low back, thoracic, or neck) lasting more than 3 months
- •Demonstrated directional preference on standardized clinical examination (i.e., movement in a specific direction reduces symptoms)
- •Sufficient proficiency in Danish to complete trial questionnaires
- •Willing and able to attend treatment sessions at designated physiotherapy clinics
- •Provide written informed consent
排除标准
- •Serious spinal pathology (e.g., fracture, malignancy, infection, inflammatory disease)
- •Cauda equina syndrome
- •Significant neurological deficits requiring urgent medical attention
- •Any diagnosed medical condition preventing safe participation in physical activity
- •Sick leave longer than 6 months at baseline
- •Pregnancy or having given birth within the past 3 months
- •Scheduled for major surgery within the next 3 months
- •Current participation in structured physiotherapy or spinal interventions outside the trial protocol
结局指标
主要结局
Average spinal pain intensity
时间窗: 12 weeks
Average spinal pain intensity over the preceding seven days measured using the Numeric Pain Rating Scale (0-10), where higher scores indicate greater pain. The primary analysis will compare the between-group difference at 12 weeks, adjusted for baseline pain intensity.
次要结局
- Short Form-12(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Fear-Avoidance Beliefs Questionnaire(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Pain Catastrophizing Scale(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Pain Self-Efficacy Questionnaire(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Working Alliance Inventory(4 weeks, 12 weeks, 26 weeks (no baseline))
- Exercise Adherence Rating Scale(4 weeks, 12 weeks, 26 weeks (no baseline))
- Patient Global Impression of Change(4 weeks, 12 weeks, 26 weeks (no baseline))
- Patient-Specific Functional Scale(Baseline, 4 weeks, 12 weeks, 26 weeks)
研究者
Claus Kjærgaard
Principal Investigator; PhD Student
Aalborg University Hospital