Protocol for a Randomized Controlled Trial Comparing the Effectiveness of Mechanical Diagnosis and Therapy Versus Generalized Exercise for Reducing Pain in Surgeons With Chronic Spinal Pain

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mechanical Diagnosis and Therapy (MDT)
  A classification-based physiotherapy intervention in which exercises are prescribed based on the individual's directional preference identified during assessment. Treatment includes repeated movements and/or sustained positions, supported by education and advice to promote self-management. Delivered by physiotherapists trained in MDT.
• Поведенческое Generalized Exercise
  A structured exercise program including strengthening, stretching, and endurance training, adapted to the individual's symptoms and capacity. The intervention does not target directional preference and reflects usual physiotherapy care for chronic spinal pain. Delivered by physiotherapists experienced in musculoskeletal rehabilitation.

Первичные конечные точки

• Average spinal pain intensity [Срок оценки: 12 weeks]

Вторичные конечные точки (8)

• Patient-Specific Functional Scale [Срок оценки: Baseline, 4 weeks, 12 weeks, 26 weeks]
• Short Form-12 [Срок оценки: Baseline, 4 weeks, 12 weeks, 26 weeks]
• Fear-Avoidance Beliefs Questionnaire [Срок оценки: Baseline, 4 weeks, 12 weeks, 26 weeks]
• Pain Catastrophizing Scale [Срок оценки: Baseline, 4 weeks, 12 weeks, 26 weeks]
• Pain Self-Efficacy Questionnaire [Срок оценки: Baseline, 4 weeks, 12 weeks, 26 weeks]
• Working Alliance Inventory [Срок оценки: 4 weeks, 12 weeks, 26 weeks (no baseline)]
• Exercise Adherence Rating Scale [Срок оценки: 4 weeks, 12 weeks, 26 weeks (no baseline)]
• Patient Global Impression of Change [Срок оценки: 4 weeks, 12 weeks, 26 weeks (no baseline)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Aalborg University Hospital — Aalborg

Публикации

• Kjaergaard C, Madeleine P, Dalboge A, Steinhilber B, Olesen AV, Nielsen TK. Comparing Mechanical Diagnosis and Therapy with generalised exercise for chronic spinal pain in surgeons: protocol for a pragmatic randomised controlled trial. BMJ Open. 2026 May 8;16(5):e117630. doi: 10.1136/bmjopen-2026-117630. PMID 42103375

Идентификаторы

NCT: NCT07293130 · N-20240046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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