Chronic Spinal PainNCT07293130
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
A study testing Mechanical Diagnosis and Therapy (MDT) and Generalized Exercise in people with Chronic Spinal Pain, run by Claus Kjærgaard at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Chronic Spinal Pain
- What is being tested?
- Mechanical Diagnosis and Therapy (MDT) and Generalized Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aalborg University Hospital
Aalborg, Aalborg, 8200
Tommy K. Nielsen, Consultant, PhD, Assoc Prof, +4597663008, t.kjaergaard@rn.dk
About this study
Official 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
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).
Read more
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.
Read the 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.
- Conditions
- Chronic Spinal Pain
- Being tested
- Mechanical Diagnosis and Therapy (MDT), Generalized Exercise
- Keywords
- spinal pain, chronic pain, musculoskeletal pain, occupational health, surgeons, rehabilitation, exercise
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Diagnosis and Therapy (MDT)Behavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Generalized Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Pain Self-Efficacy Questionnaire
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.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Working Alliance Inventory
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.
Measured: 4 weeks, 12 weeks, 26 weeks (no baseline)
Exercise Adherence Rating Scale
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.
Measured: 4 weeks, 12 weeks, 26 weeks (no baseline)
Patient Global Impression of Change
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.
Measured: 4 weeks, 12 weeks, 26 weeks (no baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start30 Mar 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spinal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claus Kjærgaard
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor-investigator, Claus Kjærgaard, Aalborg University Hospital
- Investigators
- Claus Kjærgaard, M.Sc. Health Science, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293130
- Sponsor's protocol ID
- N-20240046
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results (text, tables, figures, appendices) will be made available no earlier than 12 months after publication of the primary results and for up to 5 years. Access will be granted for academic purposes to qualified researchers upon reasonable request and approval by the Principal Investigator. Data sharing will require a formal application and a data use agreement, and data will be provided through secure transfer.
Publications
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.
PubMed 42103375
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07293130
- Acronym / sponsor ID
- N-20240046
- Conditions
- Chronic Spinal Pain
- Keywords
- spinal pain, chronic pain, musculoskeletal pain, occupational health, surgeons, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Claus KjærgaardUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Diagnosis and Therapy (MDT) | Experimental | Behavioral: Mechanical Diagnosis and Therapy (MDT)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. |
| Generalized Exercise | Active comparator | Behavioral: Generalized ExerciseNon-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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mechanical Diagnosis and Therapy (MDT) |
| Generalized ExerciseA 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. | Behavioural | Generalized Exercise |
Primary outcome
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.
8 secondary outcomes
Patient-Specific Functional Scale
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Short Form-12
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Pain Catastrophizing Scale
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Pain Self-Efficacy Questionnaire
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Working Alliance Inventory
Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)
Exercise Adherence Rating Scale
Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)
Patient Global Impression of Change
Time frame: 4 weeks, 12 weeks, 26 weeks (no baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 42103375Kjaergaard 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results (text, tables, figures, appendices) will be made available no earlier than 12 months after publication of the primary results and for up to 5 years. Access will be granted for academic purposes to qualified researchers upon reasonable request and approval by the Principal Investigator. Data sharing will require a formal application and a data use agreement, and data will be provided through secure transfer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus Kjærgaard, M.Sc. Health Science principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Diagnosis and Therapy (MDT) and Generalized Exercise in people with Chronic Spinal Pain, run by Claus Kjærgaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus Kjærgaard, M.Sc Health Science (+4599409940, clauskja@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average spinal pain intensity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07293130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.