NCT02972099

Brief Summary

The objective of the study is to assess the short-term and long-term effects of transcutaneous pulsed radio frequency treatment on the physiological status, subjective well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. Patients will be recruited within the clinic population of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

November 18, 2016

Last Update Submit

August 2, 2018

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Physiological status - Change between Baseline and Follow-up 1

    physiological status, assessed by the heart rate variability (HRV)

    Baseline; Follow-up 1 (+2-4 days)

Secondary Outcomes (2)

  • Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2

    Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)

  • Intensity of pain - Change between Baseline and Follow-up 1 & 2

    Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)

Study Arms (2)

TcPRF Group

EXPERIMENTAL

According to the standard application of the device, for the PRF procedure one 5 x 13 cm skin electrode will be placed over the forehead, the other one over the posterior aspect of the neck. PRF with a duty load of 14.8 msec/sec and an average pulse frequency of 5.11 Hz will be applied for 25min. The voltage will be set to generate a current of 1 A. Voltage and impedance will be monitored continuously during treatment and if necessary the voltage will be corrected to ensure the proper current.

Device: TcPRF

Placebo Group

PLACEBO COMPARATOR

The setup will be made as for active treatment but no current will be delivered. The patients will not be able to feel any difference to the real treatment.

Device: Placebo

Interventions

TcPRFDEVICE

Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.

Also known as: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
TcPRF Group
PlaceboDEVICE

In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.

Also known as: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 - 65
  • chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil

You may not qualify if:

  • severe medical issues, such as cancer or comparable diseases
  • severe mental disorders such as severe depression or schizophrenia
  • patients with pacemakers or with atrial fibrillation
  • Women who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Center, Swiss Paraplegic Center

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Lacher, Dr. phil.

    Pain Center, Swiss Paraplegic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

July 31, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)