Conventional Radiofrequency, Pulse Radiofrequency, and TENS for Lumbar Facet Joint Pain

NCT02942147 | Completed

• 1 other identifier: TIP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: The objective of this study is to compare the efficacy of TENS (transcutaneous electrical nerve stimulation) therapy with those of the conventional radiofrequency and pulse radiofrequency therapies. Design: A single-blind randomized controlled trial Setting: An outpatient physical therapy and rehabilitation clinic Subjects: The study included 60 patients who presented with a complaint of chronic low back pain prevailing at least for 3 months and who were diagnosed with facet joint syndrome. Interventions: The patients were randomized into 3 groups so that Group 1 (n: 20) patients would receive conventional radiofrequency therapy, Group 2 (n: 20) patients conventional TENS procedure for 15 days and Group 3 (n: 20) patients pulse radiofrequency therapy. Main measures: The patients were assessed before treatment, and at month 1 and 6 for pain (visual analogue scale), disability (Oswestry Disability Index), lumbar movements (hand-floor distance), functional status (20-meter walking times, 6-min walking distances), quality of life (Short Form 36), and depression (Beck Depression Inventory).

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change-Visual Analogue Scale

  Pre-treatment, 1 month, 6 month

Secondary Outcomes (3)

• Change-Oswestry Disability Index

  0 month, 1 month, 6 month

• Change-Short Form 36

  0 month, 1 month, 6 month

• Change-Beck Depression Inventory

  0 month, 1 month, 6 month

Study Arms (3)

conventional radiofrequency therapy

ACTIVE COMPARATOR

In the conventional radiofrequency method applied to Group 1 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position.

Procedure: Conventional or Pulse Radiofrequency

conventional TENS

ACTIVE COMPARATOR

Group 2 patients were administered TENS therapy 30 minutes a day for 15 days at the outpatient physiotherapy unit of the Physiotherapy and Rehabilitation Department. The TENS therapy was applied in the form of conventional TENS subtype with 80-100 Hz frequency by placing four electrodes on the region where the pain was most intense.

Device: TENS

pulse radiofrequency therapy

ACTIVE COMPARATOR

In the pulse radiofrequency method applied to Group 3 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position.

Procedure: Conventional or Pulse Radiofrequency

Interventions

TENS DEVICE

Group 2 patients were administered TENS therapy 30 minutes a day for 15 days at the outpatient physiotherapy unit of the Physiotherapy and Rehabilitation Department. The TENS therapy was applied in the form of conventional TENS subtype with 80-100 Hz frequency by placing four electrodes on the region where the pain was most intense.

conventional TENS

Conventional or Pulse Radiofrequency PROCEDURE

In the radiofrequency method applied to Group 1 and Group 3 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position. During this marking, the fluoroscope was directed towards cephal or caudal so that at whatever level the median ramus block was to be involved the endplate of that vertebra would become a straight line. The connection point of the superior articular protrusion was marked on the fluoroscope using the transverse process and the intervention was applied with a 22G, 10-cm radiofrequency cannula with 0.5 cm active tip in a way that bone contact was established through the tunneled vision technique. The intervention was completed after the radiofrequency procedure was applied at four levels.

conventional radiofrequency therapy; pulse radiofrequency therapy

Eligibility Criteria

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

You may qualify if:

• The study included patients who presented to the outpatient clinics of these units with the complaint of chronic low back pain prevailing for at least 3 months that had not responded to previous medical treatment

You may not qualify if:

• The patients who were excluded from the study consisted of those who had:
• coagulation disorder
• history of malignity
• mental disorder
• psychiatric disorder
• pregnancy
• prior low back surgery
• advanced (grade 3-4) spondylolisthesis defect
• extruded and sequestrated disk hernia
• spinal narrow canal
• cauda equine syndrome
• history of systemic inflammatory disease
• advanced cardiac deficiency
• diagnosis of pulmonary disease

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Congresses as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 21, 2016
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2018-01