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

NCT04103970 | Completed

• 1 other identifier: H-19024440
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Low back pain; Back surgery; Lumbar spinal fusion; Postoperative rehabilitation; Graded activity; Pain education; Disability; Pain; Fear of movement; Self-efficacy for exercise; Health related quality of life; Sedentary behavior

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sedentary behavior (sitting or reclining/lying posture)

  Sedentary behavior will in this study be defined as: "Any waking behavior characterized by a sitting or reclining/lying posture". Sedentary behavior will be assessed objectively as the number of minutes per day the patient is sedentary (lying down and sitting) measured by SENS motion activity measurement system. SENS is a small accelerometer placed within a small plaster to be worn on the patient's thigh. The SENS motion system is considered a reliable and valid device for measuring sedentary behavior. The patients will wear the accelerometer for 7 consecutive days during the week before surgery, and in 7 days at three- and 12-months post-surgery.

  3 months post-surgery

Secondary Outcomes (7)

• Change from baseline in sedentary behavior (sitting or reclining/lying posture)

  12 months

• Ostwestry Disability Index: Disability

  Baseline, 3, 6 and 12 months post-surgery

• Visual Analogue Scale (VAS pain): Pain

  Baseline, 3, 6 and 12 months post-surgery

• Tampa scale of Kinesiophobia: Fear of movement

  Baseline, 3, 6 and 12 months post-surgery

• EuroQol 5: Health-related quality of life

  Baseline, 3, 6 and 12 months post-surgery

Study Arms (2)

Control group

NO INTERVENTION

Usual care: Before surgery all patients are invited to participate in a pre-surgery seminar, where they receive information and advice about the time before, during and after the LSF. The seminar will be guided by nurses, surgeons, anesthesiologist, occupational therapists and physiotherapist. After the surgery the patient will be hospitalized on an average of 3-4 days. During hospitalization a physiotherapist consults the patients on a daily basis to provide information, guidance on mobilization and instructions in gradually progressing movement. The patients will have no restrictions on movement after surgery and should gradually return to normal activity level. Three months post-operatively all patients will receive physical rehabilitation delivered by physiotherapists in a community care center.

Intervention group: Graded Activity and Pain Education (GAPE)

EXPERIMENTAL

Patients in the intervention-group will receive usual care and 9 sessions of GAPE, 4 sessions at the hospital, 2 sessions in the patient's home and 3 sessions by telephone. Pain education in GAPE is viewed as an approach which target cognitive attitudes and beliefs about pain. The pain education will target 3 overall questions: 1. What is pain and is my pain normal? 2. What can affect my pain? 3. What can I do to relieve my pain? The education will be individually adjusted to each patient, so the patient's context and concerns regarding pain and movement are included. The aim of Graded activity is to improve the patient's functional ability by positive reinforcement of health behaviors and activity levels. Graded activity will be based on which short-term activity-goals the patient evaluates as the most important for the treatment outcome. In close collaboration with the patient the physiotherapist will set quotas for the selected exercises/activities.

Behavioral: Graded Activity and Pain Education (GAPE)

Interventions

Graded Activity and Pain Education (GAPE) BEHAVIORAL

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.

Intervention group: Graded Activity and Pain Education (GAPE)

Eligibility Criteria

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

You may qualify if:

• Patients from the Capital Region of Denmark undergoing LSF at Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup from 23st of September 2019 to 30st marts 2021 and fulfilling the following criteria:
• Low back pain \> six months
• \>18 years
• Undergoing an instrumented spinal posterior fusion of 1-2 spinal segments for degeneration of the lumbar spine, with or without an intervertebral cage placed from the anterior approach, posterior approach or from a lateral access.
• Degenerative conditions include disc herniation, spinal stenosis, spondylosis with or with-out myelopathy and spondylolisthesis.
• Read and understand Danish
• Lives no more than 1 ½ hour of transportation from Rigshospitalet, Glostrup

You may not qualify if:

• Has previously been through an LSF
• One or more of following conditions (infection, neoplasm, metastasis, metabolic bone dis-ease, fractures, post-traumatic vertebral compression/deformity or other known autoimmune arthropathies)
• Are cognitively or otherwise unable to give informed consent and adhere to the study program
• Other special conditions where a patient is judged not able to participate in the intervention by the surgeon or researcher (HT) (weakness caused by very high age, extreme poorly functional level, other serious comorbidities)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Frederiksberg University Hospital: collaborator
• Defactum, Central Denmark Region: collaborator

Study Sites (1)

Department of Occupational and Physiotherapy, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (2)

• Tegner H, Rolving N, Henriksen M, Bech-Azeddine R, Lundberg M, Esbensen BA. The Effect of Graded Activity and Pain Education After Lumbar Spinal Fusion on Sedentary Behavior 3 and 12 Months Postsurgery: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Aug;105(8):1480-1489. doi: 10.1016/j.apmr.2024.04.005. Epub 2024 Apr 27.

  PMID: 38685291 DERIVED

• Tegner H, Esbensen BA, Henriksen M, Bech-Azeddine R, Lundberg M, Nielsen L, Rolving N. The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial. Trials. 2020 Sep 15;21(1):791. doi: 10.1186/s13063-020-04719-y.

  PMID: 32933571 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain; Kinesiophobia; Sedentary Behavior

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Behavior

Study Officials

• Marius Henriksen

  Faculty of Health Sciences, Copenhagen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, MScH

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: October 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 15, 2024

Record last verified: 2023-11

Locations

DK (1)