Low Back PainBack to LifeNCT07378735
Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion
A study testing SOGA - Socratic dialogue and Graded Activity, SOGA - SOcratic dialougue and Graded-Activity and SOGA - SOcratic dialogue and Graded-Activity in people with Low Back Pain and Lumbar Spinal Fusion, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Lumbar Spinal Fusion
- What is being tested?
- SOGA - Socratic dialogue and Graded Activity, SOGA - SOcratic dialougue and Graded-Activity and SOGA - SOcratic dialogue and Graded-Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2026to Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Low back pain (LBP) > 3 months
- Read and understand the Danish language
- The participants should be a part of Frederiksberg Municipality and Copenhagen Municipality (in Denmark)
Who cannot join
- Post-traumatic vertebral compression/deformity
- Patients with the following conditions (infection, neoplasm, metastasis, metabolic bone disease, fractures or other known autoimmune arthropathies)
- Patients with patient-related circumstances (physical or mental status) that impede their ability to give informed consent and adhere to the study program (e.g., dementia, developmental disorders, or substance-induced cognitive impairment)
- Other special conditions, where the patient is judged by the surgeon as inappropriate to participate
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, 1 recruiting
- Recruiting
Department of Occupational Therapy and Physiotherapy
Glostrup Municipality, 2600
Heidi Tegner, Ph.d:, 38633092, Heidi.tegner@regionh.dk
Jan Christensen, Ph.D, 38633092, jan.christensen.02@regionh.dk
About this study
Official title: Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study
Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. The effectiveness will be evaluated on patient-specific goals, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after a lumbar spinal fusion.
Read the detailed description
In 2023, above 1400 patients underwent lumbar spinal fusion (LSF) in Denmark to treat CLBP. LSF aims to relieve pain by eliminating movement between joints by fusing one or more adjacent vertebrae. The use of LSF has been increasing because of the ageing population and because of improvements in surgical techniques and technologies.
Unfortunately, despite LSF surgery, many patients are not improving their physical activity level post-surgery, and inactivity is associated with an increased risk of disease mortality.
Therefore, healthcare professionals must address physical activity in post-surgical rehabilitation to help patients achieve healthy behaviour after surgery.
To perform physical activity, both physiological, psychological, and social factors have an influence. Further, qualitative interviews with patients undergoing LSF reveal significant concerns about engaging in physical activity after surgery. It thereby seems important that a rehabilitation approach includes a bio-psycho-social approach to incorporate the complexity of physical activity.
Rehabilitation involving physical exercises combined with a cognitive behavioural approach (CBA) has shown beneficial effects on short- and long-term functional outcomes in patients undergoing LSF. The purpose of CBA is to provide patients with techniques that can lead to a sense of control over their lives, despite pain. The approaches have no sharply defined treatment modalities but include a range of techniques that modify the behavioural, cognitive, affective, and sensory aspects of pain. Tegner et al. supported the evidence of a CBA in an RCT by showing that CBA was safe to start with just after LSF and significantly affected fear of movement and sedentary behaviour compared to usual care.
Despite the increasing consensus regarding an early CBA for patients after LSF, several problems remain unsolved. First, in many studies, the beneficial effect of an early approach consisting of CBA post-surgery is not above the minimal clinically important change.
Secondly, a huge concern is that rehabilitation, including CBA, is complex and time-consuming and thereby difficult to implement in a clinical setting where time and resources are sparse. Thirdly, it is still uncertain what drives the beneficial effects of CBA, what constitutes optimal intervention timing, and which components moderate and mediate change in physical activity behaviour.
To investigate these problems, several initiatives are needed, among others, the use of alternative research methods which include the individual patients much closer. Furthermore, a close collaboration between health sectors is important to integrate each responsible partner in the rehabilitation process, to incorporate the essential expertise and experience, and finally to be able to design an intervention that is realistic and manageable to implement in clinical practice.
Therefore, in this project, the investigators will implement an early CBA in close collaboration between partners from the hospital and a rehabilitation centre. Further, the investigators would like to test the effect of the intervention closely on patients after surgery based on function, physical activity and pain response by a single-case experimental study design (SCED) in the setting where the rehabilitation in clinical practice will be performed.
Aim and hypothesis This study aims to test the effectiveness of an early intervention consisting of a CBA on a patient-specific goal, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after an LSF. An intervention planned between sectors and delivered in a community care centre.
- Conditions
- Low Back Pain, Lumbar Spinal Fusion
- Being tested
- SOGA - Socratic dialogue and Graded Activity, SOGA - SOcratic dialougue and Graded-Activity, SOGA - SOcratic dialogue and Graded-Activity
- Keywords
- Physical activity, Low back pain, Lumbar spinal fusion, Exercise, Rehabilitation, Physiotherapy, Single-case experimental study, Cognitive behavioural approach
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOGA - Socratic dialogue and Graded ActivityBehavioural
SOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 14 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations.
The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain.
SOGA - SOcratic dialougue and Graded-ActivityBehavioural
SOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 18 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations.
The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain.
SOGA - SOcratic dialogue and Graded-ActivityBehavioural
SOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 22 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations.
The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain.
SOGA - SOcratic dialogue and Graded ActivityBehavioural
SOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 26 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations.
The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain.
| Study group | Role | What they receive |
|---|---|---|
| SOGA - 14 days post-surgery | Active comparator | The intervention SOGA will start 14 days after the participants lumbar spinal fusion. Receives: Behavioral: SOGA - Socratic dialogue and Graded Activity |
| SOGA - 18 days post-surgery | Active comparator | The intervention SOGA will start 18 days after the participants lumbar spinal fusion. Receives: Behavioral: SOGA - SOcratic dialougue and Graded-Activity |
| SOGA - 22 days post-surgery | Active comparator | The intervention SOGA will start 22 days after the participants lumbar spinal fusion. Receives: Behavioral: SOGA - SOcratic dialogue and Graded-Activity |
| SOGA - 26 days post-surgery | Active comparator | The intervention SOGA will start 28 days after the participants lumbar spinal fusion. Receives: Behavioral: SOGA - SOcratic dialogue and Graded Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-specific goal
The patient-specific goal will be reported as the primary outcome. To evaluate the participants' ability to reach their overall goal of the surgery and following rehabilitation, the participants are asked, together with the PI, to formulate an individualised, measurable, achievable, realistic/relevant, and time-bound (SMART) goal. The goal should be manageable to achieve within the three-month intervention period. The participant will evaluate their ability to reach their goal on a scale from 0 ('unable to do') to 10 ('able to perform at the same level as before the injury or problem).
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Secondary outcomes (5)
Physical activity
Physical activity is defined as any bodily movement produced by skeletal muscles that requires energy expenditure. Physical activity thereby refers to all movement, including low-, moderate- and vigorous-intensity physical activity. Total physical activity will be the main physical activity outcome; however, steps per day and light, moderate, and vigorous physical activity will be reported for exploratory purposes.
To measure the amount of time doing physical activity per day, we will use activity data from the accelerometers from the SENS Motion activity measurement system. The accelerometer will be fastened on the thigh using a band-aid that does not interfere with everyday activities. Data will be collected via a dedicated smartphone application installed on the participant's smartphone that automatically uploads data to a secure server but does not provide any data to the participant.
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Pain intensity
Patient-reported LBP intensity will in this study be defined as "The present pain in the area on the posterior aspect of the body from the lower margin of the twelfth ribs to the lower gluteal folds with or without pain referred into one or both lower limbs".
LBP intensity will be measured by the 11-point numerical rating scale (NRS), rating from 0 representing no pain to 10 representing the worst pain imaginable pain
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Fear of movement
Fear of movement will be measured by the physical activity component of the Fear-Avoidance Beliefs Questionnaire (FABQ-P). FABQ-P includes five statements answered by a score from strongly disagree (0 on a Likert scale) to strongly agree (6 on a Likert scale). The FABQ has acceptable internal consistency, test-retest reliability, and construct validity. Further, the responsiveness of the FABQ-PA is moderate in an acute LBP sample. The FABQ has been translated into Danish.
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Pain interference
Pain interference is defined as the consequences of pain on relevant aspects of a patient's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Further pain interference also includes problems with sleep and enjoyment of life. For this study, pain interference will be based on two variables by asking the participants to rate daily, on a scale ranging from 0 ("Has not affected at all") to 10 ("Has affected to the greatest extent"), to what extent pain has interfered with their "movement in daily life" and "enjoyment of life" The two aspects of pain interference have been chosen among the above broad definition of pain interference based on a validated survey among 30 patients going through LSF assessed by the principal investigator and colleagues.
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Pain self-efficacy
Self-efficacy is defined as a person's confidence or belief in the capacity to achieve goals and specific tasks. Pain self-efficacy is based on the definition of self-efficacy and reflects the patient's believed confidence in their ability to achieve specific goals and everyday activities, despite their pain. Patient-reported pain self-efficacy is measured using the short form of the Pain Self-efficacy Questionnaire (PSEQ-2). PSEQ-2 will be measured by the 7-point rating scale, ranging from 0 "Not at all confident" to 6 "Completely confident".
Measured: Daily, from 1 day post-surgery to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Model description
- The study is a single-case experimental study using a Multiple Baseline Design. A characteristic of Multiple Baseline Design is the manipulation of the intervention by introducing it at different points in time. Therefore, the cognitive-behavioural approach will start at 14, 18, 22, and 26 days post-surgery, respectively.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Capital Denmark, Lundbeck Foundation, Gigtforeningen, Danske Fysioterapeuter, Region Hovedstadens Apotek, The County of Frederiksberg
- Responsible party
- Principal investigator, Heidi Tegner, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente Appel Esbensen, Professor, Study chair, Centre for Rheumatology and Spine Diseases, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378735
- Sponsor's protocol ID
- H-25053000
- Other IDs
- p-2024-17807
- Acronym
- Back to Life
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study
- ClinicalTrials.gov ID
- NCT07378735
- Acronym / sponsor ID
- Back to Life / H-25053000
- Conditions
- Low Back Pain, Lumbar Spinal Fusion
- Keywords
- Physical activity, Low back pain, Lumbar spinal fusion, Exercise, Rehabilitation, Physiotherapy, Single-case experimental study, Cognitive behavioural approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Region Capital Denmark, Lundbeck Foundation, Gigtforeningen, Danske Fysioterapeuter, Region Hovedstadens Apotek, The County of Frederiksberg
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Jan 2026 (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.
Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. The effectiveness will be evaluated on patient-specific goals, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after a lumbar spinal fusion.
Detailed description
In 2023, above 1400 patients underwent lumbar spinal fusion (LSF) in Denmark to treat CLBP. LSF aims to relieve pain by eliminating movement between joints by fusing one or more adjacent vertebrae. The use of LSF has been increasing because of the ageing population and because of improvements in surgical techniques and technologies.
Unfortunately, despite LSF surgery, many patients are not improving their physical activity level post-surgery, and inactivity is associated with an increased risk of disease mortality.
Therefore, healthcare professionals must address physical activity in post-surgical rehabilitation to help patients achieve healthy behaviour after surgery.
To perform physical activity, both physiological, psychological, and social factors have an influence. Further, qualitative interviews with patients undergoing LSF reveal significant concerns about engaging in physical activity after surgery. It thereby seems important that a rehabilitation approach includes a bio-psycho-social approach to incorporate the complexity of physical activity.
Rehabilitation involving physical exercises combined with a cognitive behavioural approach (CBA) has shown beneficial effects on short- and long-term functional outcomes in patients undergoing LSF. The purpose of CBA is to provide patients with techniques that can lead to a sense of control over their lives, despite pain. The approaches have no sharply defined treatment modalities but include a range of techniques that modify the behavioural, cognitive, affective, and sensory aspects of pain. Tegner et al. supported the evidence of a CBA in an RCT by showing that CBA was safe to start with just after LSF and significantly affected fear of movement and sedentary behaviour compared to usual care.
Despite the increasing consensus regarding an early CBA for patients after LSF, several problems remain unsolved. First, in many studies, the beneficial effect of an early approach consisting of CBA post-surgery is not above the minimal clinically important change.
Secondly, a huge concern is that rehabilitation, including CBA, is complex and time-consuming and thereby difficult to implement in a clinical setting where time and resources are sparse. Thirdly, it is still uncertain what drives the beneficial effects of CBA, what constitutes optimal intervention timing, and which components moderate and mediate change in physical activity behaviour.
To investigate these problems, several initiatives are needed, among others, the use of alternative research methods which include the individual patients much closer. Furthermore, a close collaboration between health sectors is important to integrate each responsible partner in the rehabilitation process, to incorporate the essential expertise and experience, and finally to be able to design an intervention that is realistic and manageable to implement in clinical practice.
Therefore, in this project, the investigators will implement an early CBA in close collaboration between partners from the hospital and a rehabilitation centre. Further, the investigators would like to test the effect of the intervention closely on patients after surgery based on function, physical activity and pain response by a single-case experimental study design (SCED) in the setting where the rehabilitation in clinical practice will be performed.
Aim and hypothesis This study aims to test the effectiveness of an early intervention consisting of a CBA on a patient-specific goal, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after an LSF. An intervention planned between sectors and delivered in a community care centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- The study is a single-case experimental study using a Multiple Baseline Design. A characteristic of Multiple Baseline Design is the manipulation of the intervention by introducing it at different points in time. Therefore, the cognitive-behavioural approach will start at 14, 18, 22, and 26 days post-surgery, respectively.
| Arm | Type | Receives |
|---|---|---|
| SOGA - 14 days post-surgery | Active comparator | Behavioral: SOGA - Socratic dialogue and Graded ActivityThe intervention SOGA will start 14 days after the participants lumbar spinal fusion. |
| SOGA - 18 days post-surgery | Active comparator | Behavioral: SOGA - SOcratic dialougue and Graded-ActivityThe intervention SOGA will start 18 days after the participants lumbar spinal fusion. |
| SOGA - 22 days post-surgery | Active comparator | Behavioral: SOGA - SOcratic dialogue and Graded-ActivityThe intervention SOGA will start 22 days after the participants lumbar spinal fusion. |
| SOGA - 26 days post-surgery | Active comparator | Behavioral: SOGA - SOcratic dialogue and Graded ActivityThe intervention SOGA will start 28 days after the participants lumbar spinal fusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Low back pain (LBP) > 3 months
- Read and understand the Danish language
- The participants should be a part of Frederiksberg Municipality and Copenhagen Municipality (in Denmark)
Key exclusion criteria (4 listed)
- Post-traumatic vertebral compression/deformity
- Patients with the following conditions (infection, neoplasm, metastasis, metabolic bone disease, fractures or other known autoimmune arthropathies)
- Patients with patient-related circumstances (physical or mental status) that impede their ability to give informed consent and adhere to the study program (e.g., dementia, developmental disorders, or substance-induced cognitive impairment)
- Other special conditions, where the patient is judged by the surgeon as inappropriate to participate
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 |
|---|---|---|
| SOGA - Socratic dialogue and Graded ActivitySOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 14 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations. The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain. | Behavioural | SOGA - 14 days post-surgery |
| SOGA - SOcratic dialougue and Graded-ActivitySOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 18 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations. The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain. | Behavioural | SOGA - 18 days post-surgery |
| SOGA - SOcratic dialogue and Graded-ActivitySOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 22 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations. The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain. | Behavioural | SOGA - 22 days post-surgery |
| SOGA - SOcratic dialogue and Graded ActivitySOGA consists of six sessions over two months and is based on a cognitive behavioural approach, starting 26 days after surgery. The intervention is delivered through home visits, in-person sessions at Frederiksberg Health Care Centre, and telephone consultations. The content includes dialogue and exercise, specifically SOcratic dialogue and Graded Activity (in short called SOGA). The dialogue alternates between a deductive approach based on knowledge exchange between the physiotherapist and the participant and an inductive approach using Socratic dialogue. Socratic dialogue involves guided questioning, summaries, and reflections to support the participant's understanding of pain, surgery, and physical activity and to encourage the participant to form their own conclusions. Graded activity is based on operant conditioning principles and uses structured exercise progression to increase meaningful activity levels and reduce pain-related behaviours despite the presence of pain. | Behavioural | SOGA - 26 days post-surgery |
Primary outcome
Patient-specific goal
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
The patient-specific goal will be reported as the primary outcome. To evaluate the participants' ability to reach their overall goal of the surgery and following rehabilitation, the participants are asked, together with the PI, to formulate an individualised, measurable, achievable, realistic/relevant, and time-bound (SMART) goal. The goal should be manageable to achieve within the three-month intervention period. The participant will evaluate their ability to reach their goal on a scale from 0 ('unable to do') to 10 ('able to perform at the same level as before the injury or problem).
5 secondary outcomes
Physical activity
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
Pain intensity
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
Fear of movement
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
Pain interference
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
Pain self-efficacy
Time frame: Daily, from 1 day post-surgery to 3 months post-surgery
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 14 Aug 2026.
- Individual participant dataSharing planned: Yes. On reasonable request
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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.
Bente Appel Esbensen, Professor study chair
Centre for Rheumatology and Spine Diseases, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOGA - Socratic dialogue and Graded Activity, SOGA - SOcratic dialougue and Graded-Activity and SOGA - SOcratic dialogue and Graded-Activity in people with Low Back Pain and Lumbar Spinal Fusion, run by Copenhagen University Hospital, Rigshospitalet 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 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 Heidi Tegner, Post doc (0045 38633092, heidi.tegner@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-specific goal (time frame: Daily, from 1 day post-surgery to 3 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.