Low Back PainNCT03444493
The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation
A study testing Exercise in people with Low Back Pain and Facet Joint Pain, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Low Back Pain, Facet Joint Pain, Radiofrequency Denervation
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2015to 16 Jun 2016
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 45 year, failure to improve with conservative treatment, limited functions and daily life, pain exacerbated by rest, sitting or standing
Who cannot join
- 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
About this study
Official title: The Effect of Stabilization Exercises on Pain, Disability and Physical Performance After Radiofrequency Lumbar Facet Denervation
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.
Read the 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.
- Being tested
- Exercise
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Other: Exercise |
| Control | No intervention | Control group was informed about protecting for biomechanics of lumbar spine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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''.
Measured: Change from Baseline visual analog scale(rest) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Visual Analog Scale
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''.
Measured: Change from Baseline visual analog scale(activity) after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Visual Analog Scale
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''.
Measured: Change from Baseline visual analog scale (sleep)after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Secondary outcomes (3)
Oswestry Disability Index
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%.
Measured: Change from Baseline Oswestry Disability Index after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Physical Performance
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).
Measured: Change from Baseline physical performance tests after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Walking speed
10 meter walking speed was also measured and recorded as m/sec.
Measured: Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start15 Feb 2015
- Primary completion30 Apr 2016
- Study completion16 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Stabilizastion (exercise group) and control group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444493
- Sponsor's protocol ID
- GO14605
- Status last verified
- Feb 2018
- First submitted
- 17 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26005713Standaert 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.
PubMed 18164459
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stabilization Exercises on Pain, Disability and Physical Performance After Radiofrequency Lumbar Facet Denervation
- ClinicalTrials.gov ID
- NCT03444493
- Acronym / sponsor ID
- GO14605
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 16 Jun 2016 (actual)
- First posted
- 23 Feb 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stabilizastion (exercise group) and control group
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseThe 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. |
| Control | No intervention | –Control group was informed about protecting for biomechanics of lumbar spine. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age older than 45 year, failure to improve with conservative treatment, limited functions and daily life, pain exacerbated by rest, sitting or standing
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| ExerciseExercises 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. | Other | Exercise |
Primary outcome
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''.
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''.
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''.
3 secondary outcomes
Oswestry Disability Index
Time frame: 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)
Walking speed
Time frame: Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)
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 23 Feb 2018.
- Background: PubMed 26005713McCormick 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.
- Background: PubMed 18164459Standaert 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Low Back Pain and Facet Joint Pain, run by Hacettepe University.
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 1 inclusion and 1 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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)). 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?
On the ClinicalTrials.gov record for NCT03444493, which also lists 2 linked publications.
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 23 Feb 2018.