The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change from baseline in sedentary behavior (sitting or reclining/lying posture)
Study Overview
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.
Detailed Description
Introduction:
Over half a Billion people worldwide report low back pain (LBP), and it is the leading cause of disability at all levels of income and age groups. For the majority of people with LBP the condition has a natural course and the pain will diminish over time, but for a small percentage the conditions turns into a chronic state with significant levels of life disruption, healthcare costs and economic losses and even premature death. Lumbar spinal fusion (LSF) is a widely adopted surgical procedure for the treatment of persistent LBP, with the aim of relieving pain and increasing functional ability. Over recent decades a substantially increasing number of patients with chronic low back pain (CLBP) undergo LSF in the western world.
Unfortunately, a substantial part of the patients undergoing spine surgery still have persistent pain, functional disability and poor quality of life 4 and 8-10 years after surgery. A report from the Swedish Spine register shows that pain level remains the same 1-5 years after LSF for 25 % of the patients, and consumption of medication remains unchanged in almost 50 % of the patients.
Rationale:
The majority of patients (70 %) planned for spine surgery have fear of movement, and it is well supported in the literature that fear of movement, avoidance coping, negative affect and depression postoperative are associated with persistent pain and function after spine surgery up to 3 years postoperative. Individual differences of pain related coping strategies after LSF also seems to have an influence on the patient's sedentary behavior postoperative.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Control group
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)
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.
Intervention: Graded Activity and Pain Education (GAPE) (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in sedentary behavior (sitting or reclining/lying posture)
Time Frame: 3 months post-surgery
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.
Secondary Outcomes
- 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)
- 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)
- EuroQol 5: Health-related quality of life(Baseline, 3, 6 and 12 months post-surgery)
- Self-efficacy for exercise scale: Self-efficacy for exercise(Baseline, 3, 6 and 12 months post-surgery)
- Patient satisfaction with results of the surgery(Baseline, 3, 6 and 12 months post-surgery)
Investigators
Heidi Tegner
Principal Investigator, PT, MScH
Rigshospitalet, Denmark