Clinical trial NCT03852667: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Keywords: low back pain
recurrent
non-specific
secondary prevention
pain neuroscience education
exercise therapy
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Quality of core movement control by use of the Luomajoki test battery
timeFrame: 6 weeks
measure: Quality of proprioception of the core by use of the lumbopelvic position-reposition test
timeFrame: 6 weeks
measure: Quality of neuromuscular control by use of the lumbopelvic movement control test
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement of trunk strength by use of a hand held dynamometer
timeFrame: 6 weeks
measure: Psychosocial factor "Tampa scale of kinesiophobia"
timeFrame: 6 weeks
measure: Psychosocial factor "Pain catastrophizing scale"
timeFrame: 6 weeks
measure: Psychosocial factor "Pain disability index"
timeFrame: 6 weeks
measure: Psychosocial factor "Multidimensional pain inventory"
timeFrame: 6 weeks
measure: Psychosocial factor "Roland Morris disability questionnaire"
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Vakgroep Revalidatiewetenschappen
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghet
name: Lieven Danneels, PhD
role: STUDY_CHAIR
References: