Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
SOGA - Socratic dialogue and Graded Activity
BehavioralSOGA 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-Activity
BehavioralSOGA 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-Activity
BehavioralSOGA 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 Activity
BehavioralSOGA 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.
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: SOGA - 14 days post-surgeryActive comparator 1 intervention
Group B: SOGA - 18 days post-surgeryActive comparator 1 intervention
Group C: SOGA - 22 days post-surgeryActive comparator 1 intervention
Group D: SOGA - 26 days post-surgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Daily, from 1 day post-surgery to 3 months post-surgerySecondary outcomes
1
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.
Time frame
Daily, from 1 day post-surgery to 3 months post-surgery2
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
Time frame
Daily, from 1 day post-surgery to 3 months post-surgery3
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.
Time frame
Daily, from 1 day post-surgery to 3 months post-surgery4
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.
Time frame
Daily, from 1 day post-surgery to 3 months post-surgeryOther outcomes
1
Additional questions
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.
Time frame
Daily, from 1 day post-surgery to 3 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Region Capital Denmark
Collaborator
Lundbeck Foundation
Collaborator
Gigtforeningen
Collaborator
Danske Fysioterapeuter
Collaborator
Tværspuljen
Collaborator
The County of Frederiksberg
Collaborator
Source ClinicalTrials.gov