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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorClaus Kjærgaard

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Mechanical Diagnosis and Therapy (MDT)Experimental treatment 1 intervention
Group B: Generalized ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average spinal pain intensity

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.

Time frame
12 weeks

Secondary outcomes

1

Patient-Specific Functional Scale

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.

Time frame
Baseline, 4 weeks, 12 weeks, 26 weeks
2

Short Form-12

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.

Time frame
Baseline, 4 weeks, 12 weeks, 26 weeks
3

Fear-Avoidance Beliefs Questionnaire

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.

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

Pain Catastrophizing Scale

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Claus Kjærgaard

Lead sponsor

Aalborg University Hospital

Sponsor institution

Aalborg University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: