Low Back Pain, RecurrentNCT03852667
The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain
A study testing Pain Neuroscience Education and Exercise therapy in people with Low Back Pain, Recurrent, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Pain Neuroscience Education and Exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain, Recurrent
- Being tested
- Pain Neuroscience Education, Exercise therapy
- Keywords
- low back pain, recurrent, non-specific, secondary prevention, pain neuroscience education, exercise therapy
- Medical subject headings
- Low Back Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationBehavioural
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.
Exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention between the two test sessions |
| Pain Neuroscience Education | Active comparator | Two sessions (30 min) of Pain Neuroscience Education Receives: Behavioral: Pain Neuroscience Education |
| Pain neuroscience education - exercise | Experimental | 2 sessions of PNE and 5 sessions of exercise therapy. Receives: Behavioral: Pain Neuroscience Education; Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (6)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start29 Sep 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Danneels, PhD, Study chair, University Ghet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852667
- Sponsor's protocol ID
- EC/GK2017/1508
- Status last verified
- Nov 2021
- First submitted
- 24 Jan 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03852667
- Acronym / sponsor ID
- EC/GK2017/1508
- Conditions
- Low Back Pain, Recurrent
- Keywords
- low back pain, recurrent, non-specific, secondary prevention, pain neuroscience education, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention between the two test sessions |
| Pain Neuroscience Education | Active comparator | Behavioral: Pain Neuroscience EducationTwo sessions (30 min) of Pain Neuroscience Education |
| Pain neuroscience education - exercise | Experimental | Behavioral: Pain Neuroscience Education, Other: Exercise therapy2 sessions of PNE and 5 sessions of exercise therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience EducationThe 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. | Behavioural | Pain Neuroscience Education, Pain neuroscience education - exercise |
| Exercise therapyThe 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. | Other | Pain neuroscience education - exercise |
Primary outcome
Quality of core movement control by use of the Luomajoki test battery
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
6 secondary outcomes
Improvement of trunk strength by use of a hand held dynamometer
Time frame: 6 weeks
Psychosocial factor "Tampa scale of kinesiophobia"
Time frame: 6 weeks
Psychosocial factor "Pain catastrophizing scale"
Time frame: 6 weeks
Psychosocial factor "Pain disability index"
Time frame: 6 weeks
Psychosocial factor "Multidimensional pain inventory"
Time frame: 6 weeks
Psychosocial factor "Roland Morris disability questionnaire"
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Danneels, PhD study chair
University Ghet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Exercise therapy in people with Low Back Pain, Recurrent, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of core movement control by use of the Luomajoki test battery (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.