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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07293130
Enrollment
62
Registered
2025-12-19
Start date
2026-03-30
Completion date
2027-12-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spinal Pain

Keywords

spinal pain, chronic pain, musculoskeletal pain, occupational health, surgeons, rehabilitation, exercise

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMechanical 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.

BEHAVIORALGeneralized 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.

Sponsors

Claus Kjærgaard
Lead SponsorOTHER
Aalborg University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Outcome assessors and statisticians will remain blinded to group allocation.

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average spinal pain intensity12 weeksAverage 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

MeasureTime frameDescription
Patient-Specific Functional ScaleBaseline, 4 weeks, 12 weeks, 26 weeksPatient-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.
Short Form-12Baseline, 4 weeks, 12 weeks, 26 weeksShort 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.
Fear-Avoidance Beliefs QuestionnaireBaseline, 4 weeks, 12 weeks, 26 weeksFear-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.
Pain Catastrophizing ScaleBaseline, 4 weeks, 12 weeks, 26 weeksPain 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.
Pain Self-Efficacy QuestionnaireBaseline, 4 weeks, 12 weeks, 26 weeksPain 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.
Working Alliance Inventory4 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.
Exercise Adherence Rating Scale4 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.
Patient Global Impression of Change4 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.

Countries

Denmark

Contacts

CONTACTClaus Kjærgaard, M.Sc Health Science
clauskja@dcm.aau.dk+4599409940
CONTACTTommy K. Nielsen, Consultant, PhD, Assoc Prof
t.kjaergaard@rn.dk+4599409940
PRINCIPAL_INVESTIGATORClaus Kjærgaard, M.Sc. Health Science

Aalborg University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026