The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion

Summary

Background An increasing number of patients with chronic low back pain (CLBP) undergo lumbar spinal fusion (LSF). Unfortunately, a substantial part of the patients still has persistent pain, functional disability and poor quality of life after surgery. Research in the field of rehabilitation after LSF call for high quality research to focus on active approaches which incorporate an early bio-psycho-social focus. A focus which include the patient's context, experiences and thoughts even more in the clinical decision making.

The primary objective of this trial is to examine the effect of an early active rehabilitation-intervention consisting of Graded Activity and Pain Education (GAPE) on sedentary behavior in a population of patients undergoing LSF. The secondary objectives are to examine the effect of GAPE on disability, pain, fear of move-ment, self-efficacy for exercise and health related quality of life.

Methods:

The study is a randomized controlled trial planned to include 144 patients after LSF caused by degeneration of the lumbar spine (including spondylolisthesis). The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of 9 individual sessions, with an overall purpose to influence the patient beliefs and thoughts about movement and pain towards increased self-efficacy for exercise and decreased fear of movement. A physiotherapist will in close collaboration with the patient plan GAPE based on an in-depth pain-anamnesis, individually set functional goals and observations of the patients in their homes. The primary outcome will be "reduction in sedentary behavior" measured by an accelerometer. Sec-ondary outcome will include disability, pain, fear of movement, self-efficacy for exercise and quality of life. Data will be collected at baseline (pre-surgery), and at 3, 6- and 12-months post-surgery.

Conditions

• Low Back Pain

Interventions

BEHAVIORAL

Graded Activity and Pain Education (GAPE)

GAPE is based on a cognitive behavioral perspective that human behavior is affected by behavioral, cognitive and affective factors, this include the patient's perception of and response to pain. The perspective is a psycho-social perspective which amplify and interact with the individual patient's pathology. The overall theoretical perspective in GAPE is that fear of movement and/or lack of self-efficacy for exercise can potentially lead to disuse and sedentary behavior, a perspective modified from the fear-avoidance model. In this modified version the patients´ and the physiotherapists´ former experiences, knowledge, and beliefs are factors influencing on the patients´ experience of pain and thereby their self-efficacy for exercise and fear of movement.

Sponsors & Collaborators

• Frederiksberg University Hospital

  collaborator OTHER

• Defactum, Central Denmark Region

  collaborator OTHER_GOV

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Marius Henriksen · Faculty of Health Sciences, Copenhagen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2022-03-01

Completion

2022-03-01

Countries

• Denmark

Study Locations