Clinical trial NCT05345015: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to an electrical energy transfer (TECAR), a Transcutaneous Electrical Stimulation (TENS) or a control (CON) group in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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 4/10
* Pain incidents for for less than half the days in the past six months

Exclusion Criteria:

* radiographic evidence of inflammatory disease affecting the spine
* fracture
* important genetic structure abnormality in the spine
* 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
* No neurologic deficits (sensory, motor, or reflexes)

Primary outcomes:
measure: Change in pain Intensity
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
measure: Change in sit and reach test measurement
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
measure: Change in straight leg raising test
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
measure: Change in prone flexibility test
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
measure: Change in Oswestry index score
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
Secondary outcomes:
measure: Change in single leg balance test center of pressure
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
measure: Functional Assessment Scale for Acute Hamstring Injuries (FASH)
timeFrame: Day before, day 0, day 1, day 2, month 3, month 6
Other outcomes:
Locations:
city: Kavala
country: Greece
facility: Physiotherapy Clinic
city: Serres
country: Greece
facility: Laboratory of Neuromechanics, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki
Study officials:
affiliation: Professor
name: Eleftherios Kellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: International Hellenic University
name: Thomas Apostolou, M.D.
role: STUDY_DIRECTOR
affiliation: International Hellenic University
name: Paris Iakovidis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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