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NCT Number: NCT03444493

The Effect of Stabilization Exercises 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.

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Key information

Conditions

Low Back Pain Back Pain Disability Physical Facet Joint Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Radiofrequency Denervation Signs and Symptoms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. 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''.

  2. 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''.

  3. 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''.

Secondary outcomes

  1. 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%.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Effect of Stabilization Exercises on Pain, Disability and Physical Performance After Radiofrequency Lumbar Facet Denervation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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