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

Official title

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

Overview

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.

Interventions

• 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
• 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
• 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
• 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

Primary outcome measures

• Patient-specific goal [Time frame: Daily, from 1 day post-surgery to 3 months post-surgery]

Secondary outcome measures (5)

• 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07378735 · H-25053000 · p-2024-17807

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗