The Effect of Stabilization Exercises After Radiofrequency Lumbar Facet Denervation

NCT03444493 | Completed

• 1 other identifier: GO14605
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Facet Joint Pain; Radiofrequency Denervation; Pain; Disability Physical

Outcome Measures

Primary Outcomes (3)

• 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''.

  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''.

  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''.

  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

  Change from Baseline Oswestry Disability Index after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)

• Physical Performance

  Change from Baseline physical performance tests after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)

• Walking speed

  Change from Baseline 10 meter walking speed after radiofrequency denervation (at 2 week) and after exercise procedure (at 8 week)

Study Arms (2)

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.

Other: Exercise

Control

NO INTERVENTION

Control group was informed about protecting for biomechanics of lumbar spine.

Interventions

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.

Exercise

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (2)

• 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.

  PMID: 26005713 BACKGROUND

• 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.

  PMID: 18164459 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Stabilizastion (exercise group) and control group

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: February 23, 2018
• Study Start: February 15, 2015
• Primary Completion: April 30, 2016
• Study Completion: June 16, 2016
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share