search
Back to results

High Frequency RF Current Effects on Muscle Pain and Function

Primary Purpose

Transcutaneous Electric Nerve Stimulation, Chronic Low-back Pain, Hamstring Injury

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Radiofrequency Energy Transfer
Transcutaneous Nerve Stimulation
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcutaneous Electric Nerve Stimulation focused on measuring Sport injuries, TECAR therapy, Low back pain, Muscle injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Muscle injury group

Inclusion Criteria:

  • Acute hamstring or quadriceps or calf strain injury
  • Age above 18 years

Exclusion Criteria:

  • Other injury or musculoskeletal condition
  • Any observed organ dysfunctions
  • Receipt of medication or treatment for the past 3 months

Low back pain group

Inclusion criteria

  • Pain between bottom of ribs and buttock creases
  • Incidents for at least half the days in the past six months
  • Visual analogue pain score equal or greater than 2/10

Exclusion Criteria:

  • spinal stenosis
  • radiographic evidence of inflammatory disease affecting the spine
  • fracture
  • spondylolysis or spondylolisthesis
  • important genetic structure abnormality in the spine
  • daily intensive low back pain
  • pregnancy
  • use of medication that might influence heart rate and/or blood pressure
  • psychiatric disorders
  • receipt of medication or treatment for the past 3 months

Sites / Locations

  • Physiotherapy ClinicRecruiting
  • Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of ThessalonikiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acute effects

Chronic effects

Arm Description

The experimental group will receive one single session of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive one 20-minute session of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 24 and 48 hours after.

The experimental group will receive 10 sessions of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive 10 20-minute sessions of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 3 and 6 months after.

Outcomes

Primary Outcome Measures

Change in pain Intensity
Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain
Change in sit and reach test measurement
From supine position, with the feet in contact with a wooden box and the trunk flexed, participants attempt to reach with their hands as far as posible. Score is measured in cm. A higher measurement indicates higher flexibility
Change in straight leg raising test
From supine position, the tester raises one leg (with the knee flexed about 10-20 degrees) until discomfort is reported. The range of motion (in degrees) is stored.
Change in prone flexibility test
From the prone position, the tester flexes the knee of the participant. The maximum range of motion is stored in degrees
Change in Oswestry index score
A questionnaire which provides a score which reflects function in activities of daily living for those with acute or chronic back pain. It consists of 10 categories of questions, with a total sum of 50. Score is expressed as a percentage of 50, where 0% indicates no functional disability and pain. 100% indicates maximum functional disability and pain

Secondary Outcome Measures

Change in single leg balance test center of pressure
Displacement of center of pressure during a 30s single-leg standing test on a pressure platform. A greater center of pressure displacement indicates less postural stability.

Full Information

First Posted
April 9, 2022
Last Updated
January 6, 2023
Sponsor
Aristotle University Of Thessaloniki
search

1. Study Identification

Unique Protocol Identification Number
NCT05345015
Brief Title
High Frequency RF Current Effects on Muscle Pain and Function
Official Title
Acute and Chronic Effects of High Frequency RF Electrical Current on Pain and Muscle Function in Individuals With Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).
Detailed Description
The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. Participants referred for muscle strain injury (hamstring, quadriceps, gastrocnemius) or chronic low back pain will be randomly allocated into one of the three groups: an experimental group (muscle injuries), experimental group (low back pain) and a control group. The project is divided in two phases. In the first phase, the acute effects of TECAR therapy will be examined. Outcome measures will be obtained prior to, after, 24 and 48 hours following a single intervention session. The intervention consists of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%) or a typical transcutaneous electrical stimulation (TENS, asymmetric biphasic mode, rectangular pulse, f = 80Hz) protocol. In the chronic stage, participants will receive 10 sessions (3 times a week) receiving either protocol while outcome measurements will be obtained before, immediately, 3 and 6 months after the intervention. Analysis of variance designs will be used to compare differences in each outcome between groups at different measurement sessions. The alpha level is set to p <0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcutaneous Electric Nerve Stimulation, Chronic Low-back Pain, Hamstring Injury, Muscle; Injury, Quadriceps (Thigh), Physical Therapy, Calf Muscle Pulled
Keywords
Sport injuries, TECAR therapy, Low back pain, Muscle injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either a electrical energy transfer (TECAR) or a Transcutaneous Electrical Stimulation (TENS) group in parallel for the duration of the study
Masking
Outcomes Assessor
Masking Description
Since each group is assigned into a different intervention, masking is not possible. Outcome measures will be recorded and they will be provided codes, to ensure masking of the outcomes assessors.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute effects
Arm Type
Experimental
Arm Description
The experimental group will receive one single session of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive one 20-minute session of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 24 and 48 hours after.
Arm Title
Chronic effects
Arm Type
Experimental
Arm Description
The experimental group will receive 10 sessions of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%). The control group will receive 10 20-minute sessions of transcutaneous electrical stimulation (TENS, asynchronous rectangular pulse, f< 50Hz). Outcome measures will be measured prior to, immediately after, 3 and 6 months after.
Intervention Type
Device
Intervention Name(s)
Radiofrequency Energy Transfer
Other Intervention Name(s)
TECAR
Intervention Description
Radiofrequency Electrical Currents (TECAR) will be delivered using a winback system (Winback, Villeneuve-Loubet, France) propagating radiofrequency waves of 448 kHz using metallic electrodes via a coupling medium. Radiofrequencies will be used in the capacitive mode , which aims to treat superficial /soft tissues in the area. The "active" plate will be applied sequentially on the skin in the injured or painful region. The base plate will be located to the other side of the injured body region (for back thigh muscle injuries, for example, the base plate will be located on the frontal thigh area, to close the current circuit. Therapy will be applied for 20 minutes, with a target intensity of 40% and a frequency of 0.5Mhz.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Nerve Stimulation
Other Intervention Name(s)
TENS
Intervention Description
Transcutaneous nerve stimulation (TENS) will be delivered using a Chattanooga Intellect Advanced Combo system (Chattanooga, Hixson, TN 3 7343, USA). Two electrodes will be placed on the skin at a distance so that they cover the entire painful area. The TENS asymmetric biphasic mode (phase 300 ms, frequency 80Hz, continuous cycle) will be applied. The intensity will be adjusted between 0 and 110A, such that it is tolerable by the participant. The total application time will be 20 minutes or equal to that applied for the TECAR group.
Primary Outcome Measure Information:
Title
Change in pain Intensity
Description
Visual analogue scale. Scale ranges from 0 to 10. 0 indicates no pain and 10 maximum intensity pain
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6
Title
Change in sit and reach test measurement
Description
From supine position, with the feet in contact with a wooden box and the trunk flexed, participants attempt to reach with their hands as far as posible. Score is measured in cm. A higher measurement indicates higher flexibility
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6
Title
Change in straight leg raising test
Description
From supine position, the tester raises one leg (with the knee flexed about 10-20 degrees) until discomfort is reported. The range of motion (in degrees) is stored.
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6
Title
Change in prone flexibility test
Description
From the prone position, the tester flexes the knee of the participant. The maximum range of motion is stored in degrees
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6
Title
Change in Oswestry index score
Description
A questionnaire which provides a score which reflects function in activities of daily living for those with acute or chronic back pain. It consists of 10 categories of questions, with a total sum of 50. Score is expressed as a percentage of 50, where 0% indicates no functional disability and pain. 100% indicates maximum functional disability and pain
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6
Secondary Outcome Measure Information:
Title
Change in single leg balance test center of pressure
Description
Displacement of center of pressure during a 30s single-leg standing test on a pressure platform. A greater center of pressure displacement indicates less postural stability.
Time Frame
Day before, day 0, day 1, day 2, month 3, month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Muscle injury group Inclusion Criteria: Acute hamstring or quadriceps or calf strain injury Age above 18 years Exclusion Criteria: Other injury or musculoskeletal condition Any observed organ dysfunctions Receipt of medication or treatment for the past 3 months Low back pain group Inclusion criteria Pain between bottom of ribs and buttock creases Incidents for at least half the days in the past six months Visual analogue pain score equal or greater than 2/10 Exclusion Criteria: spinal stenosis radiographic evidence of inflammatory disease affecting the spine fracture spondylolysis or spondylolisthesis important genetic structure abnormality in the spine daily intensive low back pain pregnancy use of medication that might influence heart rate and/or blood pressure psychiatric disorders receipt of medication or treatment for the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleftherios Kellis, Ph.D.
Phone
+302310991053
Email
ekellis@phed-sr.auth.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Kellis, MSc
Phone
+302510240610
Email
anna24kellis@google.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleftherios Kellis, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy Clinic
City
Kavala
ZIP/Postal Code
64100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Kelli, MSc
Email
physiokelli@gmail.com
Facility Name
Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki
City
Serres
ZIP/Postal Code
62100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleftherios Kellis, Ph.D.
Email
ekellis@phed-sr.auth.gr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32606905
Citation
Paolucci T, Pezzi L, Centra AM, Giannandrea N, Bellomo RG, Saggini R. Electromagnetic Field Therapy: A Rehabilitative Perspective in the Management of Musculoskeletal Pain - A Systematic Review. J Pain Res. 2020 Jun 12;13:1385-1400. doi: 10.2147/JPR.S231778. eCollection 2020.
Results Reference
background
PubMed Identifier
31680597
Citation
Paolucci T, Pezzi L, Centra MA, Porreca A, Barbato C, Bellomo RG, Saggini R. Effects of capacitive and resistive electric transfer therapy in patients with painful shoulder impingement syndrome: a comparative study. J Int Med Res. 2020 Feb;48(2):300060519883090. doi: 10.1177/0300060519883090. Epub 2019 Nov 4.
Results Reference
background
Citation
Takahashi K, Suyama T, Onodera M, Hirabayashi S, Tsuzuki N, Zhong-Shi L. Clinical Effects of Capacitive Electric Transfer Hyperthermia Therapy for Lumbago. J Phys Ther Sci. 1999;11:45-51. doi:10.1589/jpts.11.45.
Results Reference
background
PubMed Identifier
25427571
Citation
Hernandez-Bule ML, Paino CL, Trillo MA, Ubeda A. Electric stimulation at 448 kHz promotes proliferation of human mesenchymal stem cells. Cell Physiol Biochem. 2014;34(5):1741-55. doi: 10.1159/000366375. Epub 2014 Nov 12.
Results Reference
background
PubMed Identifier
26524223
Citation
Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31(8):883-95. doi: 10.3109/02656736.2015.1092172. Epub 2015 Nov 2.
Results Reference
background
PubMed Identifier
32339169
Citation
Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.
Results Reference
background
PubMed Identifier
32273653
Citation
Fousekis K, Chrysanthopoulos G, Tsekoura M, Mandalidis D, Mylonas K, Angelopoulos P, Koumoundourou D, Billis V, Tsepis E. Posterior thigh thermal skin adaptations to radiofrequency treatment at 448 kHz applied with or without Indiba(R) fascia treatment tools. J Phys Ther Sci. 2020 Apr;32(4):292-296. doi: 10.1589/jpts.32.292. Epub 2020 Apr 2.
Results Reference
background
PubMed Identifier
28139939
Citation
Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19.
Results Reference
background
PubMed Identifier
29765189
Citation
Yokota Y, Sonoda T, Tashiro Y, Suzuki Y, Kajiwara Y, Zeidan H, Nakayama Y, Kawagoe M, Shimoura K, Tatsumi M, Nakai K, Nishida Y, Bito T, Yoshimi S, Aoyama T. Effect of Capacitive and Resistive electric transfer on changes in muscle flexibility and lumbopelvic alignment after fatiguing exercise. J Phys Ther Sci. 2018 May;30(5):719-725. doi: 10.1589/jpts.30.719. Epub 2018 May 8.
Results Reference
background
PubMed Identifier
33021115
Citation
Tashiro Y, Suzuki Y, Nakayama Y, Sonoda T, Yokota Y, Kawagoe M, Tsuboyama T, Aoyama T. The effect of Capacitive and Resistive electric transfer on non-specific chronic low back pain. Electromagn Biol Med. 2020 Oct 1;39(4):437-444. doi: 10.1080/15368378.2020.1830795. Epub 2020 Oct 6.
Results Reference
background

Learn more about this trial

High Frequency RF Current Effects on Muscle Pain and Function

We'll reach out to this number within 24 hrs