Back to resultsThe Effect of Secondary Prevention in Patients With Recurrent Low Back Pain
Primary Purpose
Low Back Pain, Recurrent
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pain Neuroscience Education
Exercise therapy
Sponsored by
About this trial
This is an interventional prevention trial for Low Back Pain, Recurrent focused on measuring low back pain, recurrent, non-specific, secondary prevention, pain neuroscience education, exercise therapy
Eligibility Criteria
Inclusion Criteria:
- In remission during testing
- recurrent low back pain (RLBP) >6months
- 2 or more episodes in the past year
- Pain flare of ≥24 hours, characterized by an increase of ≥2 on an Numeric Rating Scale (NRS) scale and/or ≥5 on the Roland Morris Disability Questionnaire
- Followed by a pain-free episode of ≥1 month, characterized by a 0/10 on an NRS scale and/or <2 on the Roland Morris Disability Questionnaire
- Non-specific RLBP (no cause for Low back pain (LBP); >3y post discus herniation)
- 1 year or more post-natal
Exclusion Criteria:
- Use of antidepressants or analgesics (except for NSAIDs or paracetamol), taken 2 weeks before the testing
- Neurologic, respiratory, circulatory, or severe orthopedic diseases
- Pregnancy
- Specific LBP causes
- A history of cognitive exercise therapy and/or specific motor control training
- current treatment or new therapies starting <6 weeks before baseline assessment
Sites / Locations
- Vakgroep Revalidatiewetenschappen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control
Pain Neuroscience Education
Pain neuroscience education - exercise
Arm Description
No intervention between the two test sessions
Two sessions (30 min) of Pain Neuroscience Education
2 sessions of PNE and 5 sessions of exercise therapy.
Outcomes
Primary Outcome Measures
Quality of core movement control by use of the Luomajoki test battery
A core movement control test battery is performed pre and post intervention, to assess a possible movement control dysfunction of the low back. This test battery consists out of six tests: waiters bow, dorsal tilt of pelvis actively in upright standing, one leg stance, sitting knee extension test, quadruped position, prone lying active knee flexion.
Quality of proprioception of the core by use of the lumbopelvic position-reposition test
A lumbopelvic position-reposition test was performed pre and post intervention for measuring proprioceptive deficits in the core in the subjects. This repositioning test evaluates the participant's repositioning accuracy of the pelvis, low back and trunk after a dynamic task.
Quality of neuromuscular control by use of the lumbopelvic movement control test
The neuromuscular control of the lumbar region is measured pre and post intervention. This test evaluates a repeated lumbopelvic movement on five categories; quality of the lumbopelvic motion, control of the adjacent areas, preference of motion direction, breathing, and the amount of good quality repetitions.
Secondary Outcome Measures
Improvement of trunk strength by use of a hand held dynamometer
The maximal voluntary contraction of the extensor and flexor muscles of the back will be assessed pre and post intervention, using a hand-held dynamometer. This measurement will provide an insight on the total muscle strength.
Psychosocial factor "Tampa scale of kinesiophobia"
The clinical questionnaire "Tampa scale of kinesiophobia" was used to assess the the amount of pain related anxiety in low back pain, pre and post intervention. This scale contains 17 items rated on a 4-point Likert scale (ranging from 1= highly agree to 4 highly disagree). A higher total score means a higher amount of fear of movement.
Psychosocial factor "Pain catastrophizing scale"
The clinical questionnaire "Pain catastrophizing scale" was used to assess the amount of catastrophizing pre and post intervention. The PCS contains 13 items rated on a 5-point Likert scale (ranging from 0 =not at all to 4 =all the time). The total score and 3 subscale scores are measured (rumination, magnification and helplessness) with subscale scores ranging between 0-16, 0-12, and 0-24, respectively. A score ≥11 for rumination, ≥5 for magnification, ≥13 for helplessness or a total score of ≥30 are clinically relevant cut offs for identifying pain catastrophizing.
Psychosocial factor "Pain disability index"
The clinical questionnaire "pain disability index" was used to assess the degree of interruption of activities from daily life due to pain in the previous week, pre and post intervention. The PDI contains 7 items scored on a Likert scale with scores ranging between 0 (=no disability at all) and 10 (=affectation or disruption of an individual's ability to participate in activities due to pain). Higher scores indicate more pain related disability.
Psychosocial factor "Multidimensional pain inventory"
The clinical questionnaire "Multidimensional pain inventory" was used to assess the different aspects of pain and their influence on daily life experiences pre and post intervention. The MPI contains 28 items rated on a 7-point Likert scale (ranging from 0 to 6). All 28 items are divided among 5 subscales (pain severity, perceived life control and affective distress, interference with the daily life due to present pain complaint and social support). A higher score on the social support and life control subscales represents a better outcome. A higher score on the subscales interference in daily life, pain severity and affective distress represents a less favourable outcome.
Psychosocial factor "Roland Morris disability questionnaire"
The clinical questionnaire was used to assess the disability due to low back pain in the last 24 hours, pre and post intervention. The RMDS contains 24 statements. The patient is instructed to put a mark next to each appropriate statement and all marks are added up. Greater levels of disability are reflected by higher numbers on a 24-point scale. A difference of ≥5 indicates a clinical important change.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852667
Brief Title
The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain
Official Title
The Effect of Secondary Prevention for Low Back Pain by Means of Pain Education and Exercise Therapy in Patients With Recurrent Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the effect of a secondary intervention program for low back pain in patients with recurrent low back pain. One third of the subject will receive no therapy, one third wil receive 2 sessions of pain neuroscience education (PNE) and one third will receive two sessions of PNE and 5 sessions of exercise therapy over 6 weeks.
Detailed Description
Participants:
60 individuals with recurrent non-specific LBP were recruited through advertisement in sport facilities, social media and among friends and family.
Testing:
The testing was performed before and after a six week period by three blinded 2nd master students of physiotherapy of University of Ghent. The pre and post testing were almost identical and lasted 1 hour, only for the first testing an anamnesis was conducted to evaluate inclusion and exclusion criteria. The identical parts were tests for motor control, muscle performance and psychosocial factors.
Intervention:
The subjects were divided into 3 groups, only group B and C were given treatment. Group B had 2 sessions PNE over a period of two weeks. Group C received 2 sessions of PNE and 5 sessions of exercise therapy over a period of six weeks. Each of the sessions lasted 30 minutes and took place at the clinical practice room at the university of Ghent. Group C began the exercise therapy a week after the second session of PNE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent
Keywords
low back pain, recurrent, non-specific, secondary prevention, pain neuroscience education, exercise therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomization schedule was extracted from the website www.sealedenvelope.com . The randomization was expected to have the same amount of one gender in each group. The control group was group A, the group that only received PNE was group B and the group who received PNE and exercise therapy was group C.
Masking
InvestigatorOutcomes Assessor
Masking Description
The leading investigators, as well as the outcome assessors are masked and do not know to which arm the subjects are allocated to.
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention between the two test sessions
Arm Title
Pain Neuroscience Education
Arm Type
Active Comparator
Arm Description
Two sessions (30 min) of Pain Neuroscience Education
Arm Title
Pain neuroscience education - exercise
Arm Type
Experimental
Arm Description
2 sessions of PNE and 5 sessions of exercise therapy.
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
The PNE intervention consisted of 2 sessions of 30 minutes. In the first session, the main goal is to explain the patient why pain is important and why people can't live without it. Besides it is explained why objective findings such as x-rays, MRI, CT scans, etc. often lack significant findings despite the pain that the patient experiences. This first session of pain education might help the patient understand that pain is necessarily a result from tissue damage. Furthermore, the session explains the right approach to conquer pain and to avoid going down in this vicious circle of low back pain. The second session of PNE, is a revision of the first session, continuing on what was unclear from the first session.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
The exercise therapy varies form analytical exercises in the first sessions, to functional and sports related exercises near the following sessions. The first session focuses on the lumbar neuromuscular control of the patients: first a voluntary contraction of the Transversus Abdominis muscle, the Multifidus muscle and the pelvic floor muscles is learned. When the subject is able to maintain the combined contraction for 10 times, the exercises evolve to more complicated tasks. In the final stage, more functional and sport specific tasks will be exercised.
Primary Outcome Measure Information:
Title
Quality of core movement control by use of the Luomajoki test battery
Description
A core movement control test battery is performed pre and post intervention, to assess a possible movement control dysfunction of the low back. This test battery consists out of six tests: waiters bow, dorsal tilt of pelvis actively in upright standing, one leg stance, sitting knee extension test, quadruped position, prone lying active knee flexion.
Time Frame
6 weeks
Title
Quality of proprioception of the core by use of the lumbopelvic position-reposition test
Description
A lumbopelvic position-reposition test was performed pre and post intervention for measuring proprioceptive deficits in the core in the subjects. This repositioning test evaluates the participant's repositioning accuracy of the pelvis, low back and trunk after a dynamic task.
Time Frame
6 weeks
Title
Quality of neuromuscular control by use of the lumbopelvic movement control test
Description
The neuromuscular control of the lumbar region is measured pre and post intervention. This test evaluates a repeated lumbopelvic movement on five categories; quality of the lumbopelvic motion, control of the adjacent areas, preference of motion direction, breathing, and the amount of good quality repetitions.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Improvement of trunk strength by use of a hand held dynamometer
Description
The maximal voluntary contraction of the extensor and flexor muscles of the back will be assessed pre and post intervention, using a hand-held dynamometer. This measurement will provide an insight on the total muscle strength.
Time Frame
6 weeks
Title
Psychosocial factor "Tampa scale of kinesiophobia"
Description
The clinical questionnaire "Tampa scale of kinesiophobia" was used to assess the the amount of pain related anxiety in low back pain, pre and post intervention. This scale contains 17 items rated on a 4-point Likert scale (ranging from 1= highly agree to 4 highly disagree). A higher total score means a higher amount of fear of movement.
Time Frame
6 weeks
Title
Psychosocial factor "Pain catastrophizing scale"
Description
The clinical questionnaire "Pain catastrophizing scale" was used to assess the amount of catastrophizing pre and post intervention. The PCS contains 13 items rated on a 5-point Likert scale (ranging from 0 =not at all to 4 =all the time). The total score and 3 subscale scores are measured (rumination, magnification and helplessness) with subscale scores ranging between 0-16, 0-12, and 0-24, respectively. A score ≥11 for rumination, ≥5 for magnification, ≥13 for helplessness or a total score of ≥30 are clinically relevant cut offs for identifying pain catastrophizing.
Time Frame
6 weeks
Title
Psychosocial factor "Pain disability index"
Description
The clinical questionnaire "pain disability index" was used to assess the degree of interruption of activities from daily life due to pain in the previous week, pre and post intervention. The PDI contains 7 items scored on a Likert scale with scores ranging between 0 (=no disability at all) and 10 (=affectation or disruption of an individual's ability to participate in activities due to pain). Higher scores indicate more pain related disability.
Time Frame
6 weeks
Title
Psychosocial factor "Multidimensional pain inventory"
Description
The clinical questionnaire "Multidimensional pain inventory" was used to assess the different aspects of pain and their influence on daily life experiences pre and post intervention. The MPI contains 28 items rated on a 7-point Likert scale (ranging from 0 to 6). All 28 items are divided among 5 subscales (pain severity, perceived life control and affective distress, interference with the daily life due to present pain complaint and social support). A higher score on the social support and life control subscales represents a better outcome. A higher score on the subscales interference in daily life, pain severity and affective distress represents a less favourable outcome.
Time Frame
6 weeks
Title
Psychosocial factor "Roland Morris disability questionnaire"
Description
The clinical questionnaire was used to assess the disability due to low back pain in the last 24 hours, pre and post intervention. The RMDS contains 24 statements. The patient is instructed to put a mark next to each appropriate statement and all marks are added up. Greater levels of disability are reflected by higher numbers on a 24-point scale. A difference of ≥5 indicates a clinical important change.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In remission during testing
recurrent low back pain (RLBP) >6months
2 or more episodes in the past year
Pain flare of ≥24 hours, characterized by an increase of ≥2 on an Numeric Rating Scale (NRS) scale and/or ≥5 on the Roland Morris Disability Questionnaire
Followed by a pain-free episode of ≥1 month, characterized by a 0/10 on an NRS scale and/or <2 on the Roland Morris Disability Questionnaire
Non-specific RLBP (no cause for Low back pain (LBP); >3y post discus herniation)
1 year or more post-natal
Exclusion Criteria:
Use of antidepressants or analgesics (except for NSAIDs or paracetamol), taken 2 weeks before the testing
Neurologic, respiratory, circulatory, or severe orthopedic diseases
Pregnancy
Specific LBP causes
A history of cognitive exercise therapy and/or specific motor control training
current treatment or new therapies starting <6 weeks before baseline assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Danneels, PhD
Organizational Affiliation
University Ghet
Official's Role
Study Chair
Facility Information:
Facility Name
Vakgroep Revalidatiewetenschappen
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain
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