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

NCT07293130 | Not Yet Recruiting

• 1 other identifier: N-20240046
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spinal Pain

Keywords

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

Outcome Measures

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.

  12 weeks

Secondary Outcomes (8)

• Patient-Specific Functional Scale

  Baseline, 4 weeks, 12 weeks, 26 weeks

• 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

Study Arms (2)

Mechanical Diagnosis and Therapy (MDT)

EXPERIMENTAL

Individualized exercise-based rehabilitation delivered according to the Mechanical Diagnosis and Therapy (MDT) approach. Treatment is based on a standardized assessment to identify directional preference, with exercises prescribed accordingly. Participants receive education, self-management advice, and ergonomic guidance relevant to their work. Up to six physiotherapy sessions are provided over 26 weeks, with home exercises prescribed and progressed between visits.

Behavioral: Mechanical Diagnosis and Therapy (MDT)

Generalized Exercise

ACTIVE COMPARATOR

Non-direction-specific, guideline-based exercise rehabilitation for chronic spinal pain. The program includes strengthening, flexibility, and endurance exercises tailored to the individual but not based on directional preference. Participants receive education, self-management advice, and ergonomic guidance. Up to six physiotherapy sessions are provided over 26 weeks, with home exercises prescribed and progressed between visits.

Behavioral: Generalized Exercise

Interventions

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.

Mechanical Diagnosis and Therapy (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.

Generalized Exercise

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Claus Kjærgaard: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, Aalborg, 8200, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Claus Kjærgaard, M.Sc. Health Science

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus Kjærgaard, M.Sc Health Science

CONTACT

+4599409940; clauskja@dcm.aau.dk

Tommy K. Nielsen, Consultant, PhD, Assoc Prof

CONTACT

+4599409940; t.kjaergaard@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessors and statisticians will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; PhD Student

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of trial results and remain available for 5 years.
• Access Criteria: Data will be shared with qualified researchers for academic purposes only. Access requires submission of a reasonable request and a formal application to the Principal Investigator. Approved applicants will receive de-identified data and supporting materials through secure data transfer.

Locations

DK (1)