The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation

February 22, 2018 updated by: HATİCE ÇETİN, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO14605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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