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NCT Number: NCT07293130

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

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.

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Key information

Conditions

Chronic Spinal Pain Behavior Chronic Pain Motor Activity Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, 8200, Denmark

Location contact

Tommy K. Nielsen, Consultant, PhD, Assoc Prof

CONTACT

[email protected]

+4597663008

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mechanical Diagnosis and Therapy (MDT)

Behavioral

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.

Generalized Exercise

Behavioral

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.

Primary outcomes

  1. Average spinal pain intensity

    Time frame: 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.

Secondary outcomes

  1. Patient-Specific Functional Scale

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

    Patient-Specific Functional Scale (PSFS). Self-reported functional limitations assessed on a scale from 0 to 10 for each activity, where 0 indicates inability to perform the activity and 10 indicates ability to perform at the pre-injury level. Higher scores indicate better function. Total score will be analyzed as change from baseline by group mean.

  2. Short Form-12

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

    Short Form-12 Health Survey (SF-12). Health-related quality of life assessed using Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, each ranging from 0 to 100, where higher scores indicate better health status. Scores will be analyzed as change from baseline by group mean.

  3. Fear-Avoidance Beliefs Questionnaire

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

    Fear-Avoidance Beliefs Questionnaire (FABQ). Fear of movement and work-related beliefs assessed on a scale from 0 to 96, where higher scores indicate greater fear-avoidance beliefs. Total score will be analyzed as change from baseline by group mean.

  4. Pain Catastrophizing Scale

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

    Pain Catastrophizing Scale (PCS). Pain catastrophizing assessed on a scale from 0 to 52, where higher scores indicate greater catastrophizing. Total score will be analyzed as change from baseline by group mean.

  5. Pain Self-Efficacy Questionnaire

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

    Pain Self-Efficacy Questionnaire (PSEQ). Pain self-efficacy assessed on a scale from 0 to 60, where higher scores indicate greater confidence in performing activities despite pain. Total score will be analyzed as change from baseline by group mean.

  6. Working Alliance Inventory

    Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)

    Working Alliance Inventory (WAI). Therapeutic alliance assessed on a scale from 12 to 84, where higher scores indicate stronger therapeutic alliance. Total score will be analyzed as change from prior assessment by group mean.

  7. Exercise Adherence Rating Scale

    Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)

    Exercise Adherence Rating Scale (EARS). Exercise adherence assessed on a scale from 0 to 24, where higher scores indicate greater adherence to prescribed exercise. Total score will be analyzed as change from prior assessment by group mean.

  8. Patient Global Impression of Change

    Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)

    Patient Global Impression of Change (PGIC). Patient-rated global improvement assessed on a 7-point scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. Scores will be summarized by group at each follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Claus Kjærgaard, M.Sc Health Science

CONTACT

[email protected]

+4599409940

Tommy K. Nielsen, Consultant, PhD, Assoc Prof

CONTACT

[email protected]

+4599409940

Sponsors and collaborators

Lead sponsor

Claus Kjærgaard

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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