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Clinical Trials/NCT07378735
NCT07378735
Not yet recruiting
Not Applicable

Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study

Rigshospitalet, Denmark0 sites12 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
12
Primary Endpoint
Patient-specific goal

Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Masking Description

Full blinding is not feasible in this MBD. Allocation to baseline length will be concealed until the intervention is initiated. The randomisation schedule will be generated by co-investigator Jan Christensen.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

SOGA - 14 days post-surgery

Active Comparator

The intervention SOGA will start 14 days after the participants lumbar spinal fusion.

Intervention: SOGA - Socratic dialogue and Graded Activity (Behavioral)

SOGA - 18 days post-surgery

Active Comparator

The intervention SOGA will start 18 days after the participants lumbar spinal fusion.

Intervention: SOGA - SOcratic dialougue and Graded-Activity (Behavioral)

SOGA - 22 days post-surgery

Active Comparator

The intervention SOGA will start 22 days after the participants lumbar spinal fusion.

Intervention: SOGA - SOcratic dialogue and Graded-Activity (Behavioral)

SOGA - 26 days post-surgery

Active Comparator

The intervention SOGA will start 28 days after the participants lumbar spinal fusion.

Intervention: SOGA - SOcratic dialogue and Graded Activity (Behavioral)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Physical activity(Daily, from 1 day post-surgery to 3 months post-surgery)
  • Pain intensity(Daily, from 1 day post-surgery to 3 months post-surgery)
  • Fear of movement(Daily, from 1 day post-surgery to 3 months post-surgery)
  • Pain interference(Daily, from 1 day post-surgery to 3 months post-surgery)
  • Pain self-efficacy(Daily, from 1 day post-surgery to 3 months post-surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heidi Tegner

Research Physiotherapist, Post doc

Rigshospitalet, Denmark

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