- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444493
The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation
The Effect of Stabilization Exercises on Pain, Disability and Physical Performance After Radiofrequency Lumbar Facet Denervation
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
The exercise group performed specific localized exercises aimed at restoring the stabilizing protective function of the transversus abdominis (TrA).
The exercises were designed specifically to activate and train the isometric holding function of the TrA muscle at the affected vertebral segment.
Additionally, the exercise group was informed about protecting for biomechanics of lumbar spine.
|
Exercises were basically performed in 3 phases in this study.
In the first phase; effectively and correctly contraction of TrA and multifidus muscles and how the patients adapted to daily life activities was taught.
In the second phase; was aimed that the protection of stabilization by counteracting more muscle activation, in the third phase neutral position along with the activities required high level control.
|
No Intervention: Control
Control group was informed about protecting for biomechanics of lumbar spine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: Change from Baseline visual analog scale(rest) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Patients were asked to marked the level of pain on a 10 cm at rest, activity and sleep; VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable''.
|
Change from Baseline visual analog scale(rest) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Visual Analog Scale
Time Frame: Change from Baseline visual analog scale(activity) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Patients were asked to marked the level of pain on a 10 cm at activity; VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable''.
|
Change from Baseline visual analog scale(activity) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Visual Analog Scale
Time Frame: Change from Baseline visual analog scale (sleep)after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Patients were asked to marked the level of pain on a 10 cm at sleep; VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable''.
|
Change from Baseline visual analog scale (sleep)after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index
Time Frame: Change from Baseline Oswestry Disability Index after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
The ODI assesses ten different aspects of disability (pain, personal care, lifting, sitting, standing, sleeping, sex life, social life, walking and travelling).
Each parameter is scored from 0 to 5, with 0 indicating no functional limitation due to pain and 5 indicating a major functional disability due to low back pain.
This questionnaire is scored using a global percentage score.
The obtainable maximum score is 50, which corresponds to 100%.
|
Change from Baseline Oswestry Disability Index after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Physical Performance
Time Frame: Change from Baseline physical performance tests after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Eight physical performance tests (PPT) of daily activities such as climbing stairs, picking up something from the floor, bending forward, rolling up from supine position, putting on a sock, standing up from a lying position etc. were evaluated.
The tests were observed by trained physiotherapist, who judged the patients' individual performance in each test using four grades of movement quality that were recorded on a four-point ordinal scale (0; performs activity without any difficulty, 3; restricted movement: cannot perform activity).
|
Change from Baseline physical performance tests after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Walking speed
Time Frame: Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
10 meter walking speed was also measured and recorded as m/sec.
|
Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO14605
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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