Clinical trial NCT03444493: The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation
Official title: The Effect of Stabilization Exercises on Pain, Disability and Physical Performance After Radiofrequency Lumbar Facet Denervation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Facet Joint Pain
Radiofrequency Denervation
Pain
Disability Physical
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stabilizastion (exercise group) and control group
Primary purpose: TREATMENT

Brief summary: A gap of knowledge exists on the understanding of the acute effects of stabilization exercises on pain, disability and physical performance when applied after radiofrequency denervation. Therefore, the main objective of this study is to show the effects of stabilization exercises when started in acute period and also reduce the frequency of recurrence low back pain of patients with FJS after radiofrequency denervation.

Detailed description: Lumbar facet joint syndrome has been described as a potential cause of low back pain and affects an estimated 4% to 8% of those low back pain patients without neurological deficits or radiographic evidence of lumbar spine disease. The levels of physical performance and functional disability of the patients with lumbar FJS are affected because of the chronicity of the pain.

Radiofrequency denervation (RFD) is one of the therapautic procedures are used most commonly in treatment of facet joint syndrome. Numerous placebo-controlled trials have examined lumbar facet pain and demonstrated that RFD yields positive results in lumbar pain in properly selected patients. The lumbar stabilization exercise is based on the control of the local muscle system (multifidus, transversus abdominis, diaphragm and pelvic floor muscles) responsible for ensuring segmental stability of the vertebral colon in recent years.

In the clinical trials, stabilization exercises have been shown to reduce pain, improves physical performance and prevent the recurrent low back pain by strengthing of muscles supporting the vertebral colon.

Therefore, the main objective of this study is to show the effects of stabilization exercises when started in acute period and also reduce the frequency of recurrence low back pain of patients with FJS after radiofrequency denervation.

Eligibility criteria: Inclusion Criteria:

* age older than 45 year, failure to improve with conservative treatment, limited functions and daily life, pain exacerbated by rest, sitting or standing

Exclusion Criteria:

* previous surgical intervention in the spine or hip, previous local injection to the lumbar spine facet joint, current treatment with a narcotic drug, impairment of cognition or speech

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from Baseline visual analog scale(rest) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
measure: Visual Analog Scale
timeFrame: Change from Baseline visual analog scale(activity) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
measure: Visual Analog Scale
timeFrame: Change from Baseline visual analog scale (sleep)after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Change from Baseline Oswestry Disability Index after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
measure: Physical Performance
timeFrame: Change from Baseline physical performance tests after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
measure: Walking speed
timeFrame: Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Other outcomes:
Locations:
Study officials:
References:
citation: McCormick ZL, Marshall B, Walker J, McCarthy R, Walega DR. Long-Term Function, Pain and Medication Use Outcomes of Radiofrequency Ablation for Lumbar Facet Syndrome. Int J Anesth Anesth. 2015;2(2):028. doi: 10.23937/2377-4630/2/2/1028.
citation: Standaert CJ, Weinstein SM, Rumpeltes J. Evidence-informed management of chronic low back pain with lumbar stabilization exercises. Spine J. 2008 Jan-Feb;8(1):114-20. doi: 10.1016/j.spinee.2007.10.015.