Low Back Pain, Recurrent Clinical Trial
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
Verified date | November 2021 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Vakgroep Revalidatiewetenschappen | Gent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 weeks | |
Primary | 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. | 6 weeks | |
Primary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks |
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