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

NCT07378735 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-03

No results posted yet for this study

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

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 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.

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.

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.

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.

Sponsors & Collaborators

  • Health Care Centre Frederiksberg

    collaborator UNKNOWN
  • The Danish Arthritis Association

    collaborator UNKNOWN
  • The Capital Region of Denmark Research Foundation

    collaborator UNKNOWN
  • Lundbeck Foundation

    collaborator OTHER
  • Danish Physiotherapists

    collaborator UNKNOWN
  • The Cross-Sectoral Fund

    collaborator UNKNOWN
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Bente Appel Esbensen, Professor · Centre for Rheumatology and Spine Diseases, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-11-30
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378735 on ClinicalTrials.gov