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

NCT07378735 | Not Yet Recruiting

• 2 other identifiers: H-25053000p-2024-17807
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

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).

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

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Additional questions

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

Study Arms (4)

SOGA - 14 days post-surgery

ACTIVE COMPARATOR

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

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.

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.

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.

Behavioral: SOGA - SOcratic dialogue and Graded Activity

Interventions

SOGA - SOcratic dialogue and Graded Activity BEHAVIORAL

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 - 14 days post-surgery

SOGA - SOcratic dialougue and Graded-Activity BEHAVIORAL

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 - 18 days post-surgery

SOGA - SOcratic dialogue and Graded-Activity BEHAVIORAL

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 - 22 days post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Health Care Centre Frederiksberg: collaborator
• The Danish Arthritis Association: collaborator
• The Capital Region of Denmark Research Foundation: collaborator
• Lundbeck Foundation: collaborator
• Danish Physiotherapists: collaborator
• The Cross-Sectoral Fund: collaborator

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Bente Appel Esbensen, Professor

  Centre for Rheumatology and Spine Diseases, Rigshospitalet

  STUDY CHAIR

Central Study Contacts

Heidi Tegner, Post doc

CONTACT

0045 38633092; heidi.tegner@regionh.dk

Jan Christensen, Associate Professor

CONTACT

0045 38633092; jan.christensen.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiotherapist, Post doc

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• 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.