Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion (Back to Life)

August 12, 2026 updated by: Heidi Tegner, Rigshospitalet, Denmark

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The investigators will in total include 12 patients undergoing an LSF from the Centre for Rheumatology and Spine Diseases at Rigshospitalet, Denmark.

Before inclusion, a pilot of three participants will be performed.

Inclusion Criteria for all included:

  • ≥ 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SOGA - 14 days post-surgery
The intervention SOGA will start 14 days after the participants lumbar spinal fusion.
Behavioral: SOGA - Socratic dialogue and Graded Activity

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.
Active Comparator: SOGA - 18 days post-surgery
The intervention SOGA will start 18 days after the participants lumbar spinal fusion.
Behavioral: SOGA - SOcratic dialougue and Graded-Activity

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.
Active Comparator: SOGA - 22 days post-surgery
The intervention SOGA will start 22 days after the participants lumbar spinal fusion.
Behavioral: SOGA - SOcratic dialogue and Graded-Activity

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.
Active Comparator: SOGA - 26 days post-surgery
The intervention SOGA will start 28 days after the participants lumbar spinal fusion.
Behavioral: SOGA - SOcratic dialogue and Graded Activity

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Daily, from 1 day post-surgery to 3 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Daily, from 1 day post-surgery to 3 months post-surgery

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.
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

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
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
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.
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 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.
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
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".
Daily, from 1 day post-surgery to 3 months post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additional questions
Time Frame: Daily, from 1 day post-surgery to 3 months post-surgery

Two additional questions will be asked each day, including a free-text area:

  1. Have you taken more or less pain medication, and if yes, please briefly explain why?
  2. Has anything happened in the past 24 hours, apart from your normal daily routine, that has affected your physical activity or pain? If yes, please briefly explain what has affected your physical activity or pain.
Daily, from 1 day post-surgery to 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lundbeck Foundation
Region Capital Denmark
Gigtforeningen
Danske Fysioterapeuter
The County of Frederiksberg
Tværspuljen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bente Appel Esbensen, Professor, Centre for Rheumatology and Spine Diseases, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-25053000
  • p-2024-17807 (Other Identifier: The Danish Data Protection Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On reasonable request

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

De-identified individual participant data will be shared with qualified researchers who have a scientifically relevant research question. Data sharing will be subject to approval of a written research proposal describing the planned analyses. Access will require the signing of a data sharing agreement outlining the purpose of use, data protection, and confidentiality. Requests can be submitted by contacting the study investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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