Upper Trapezius Trigger PointsNCT05275634
Interferential Current And Trapezius Myofascial Trigger Points
A study testing Stander treatment, Interferential current with carrier frequency 2 KHz and Interferential current with carrier frequency 4 KHz in people with Upper Trapezius Trigger Points, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of different carrier frequencies of interferential current on pressure pain threshold, neck disability, cervical range of motion and upper trapezius muscle activity when applied on upper trapezius chronic myofascial trigger points: Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Upper Trapezius Trigger Points
- What is being tested?
- Stander treatment, Interferential current with carrier frequency 2 KHz and Interferential current with carrier frequency 4 KHz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages from18-29 years old with unilateral chronic myofascial trigger points in upper trapezius muscle will be included in this study.
- Participants have chronic myofascial trigger points if they have pain with pressure, local twitch response, jump sign, limited range of motion and referred pain lies over the lateral aspect of the upper trapezius fibers and superiorly to the ipsilateral occiput.
- Normal body mass index (BMI) from 18-24.9 Kg/m (BMI = body mass in kg divided by participant height in meters).
Who cannot join
- Onset of pain less than 3 months
- History of whiplash injury
- History of cervical spine surgery
- Cervical radiculopathy or myelopathy and cervical disc lesion
- Cervical spondylolisthesis
- Having multiple sclerosis, thyroid dysfunction and chronic infection
Show all 12Show fewer
- Having rheumatologic condition as poly articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases
- Skin disease and impaired sensation
- Phobia of using electrical current
- Pregnancy, tumor, thrombosis and pacemaker
- Administration of regular analgesic drugs or any medications that affect skin sensation.
- Receiving physical therapy intervention during the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Carrier Frequencies of Interferential Current on Upper Trapezius Myofascial Trigger Points: A Randomized Controlled Trial
To investigate the effect of different carrier frequencies of interferential current on pressure pain threshold, neck disability, cervical range of motion and upper trapezius muscle activity when applied on upper trapezius chronic myofascial trigger points: Randomized Controlled Trial
Read the detailed description
Interferential current (IFC) is a medium frequency current derived from the interference of two symmetrical, but asynchronous alternating currents ranged from 1 to 10 KHz. The two main currents resulting in a single interference current with properties uniquely different from the two original currents.The lesser current of the two original currents is termed the carrier frequency and the interference current is called the beat frequency. A specific beat frequency can be obtained from several possible interference currents as long as the difference between the original currents is the same. For electro pain modulation, IFC is commonly used form of electrotherapy. It has the advantage of reducing the skin impedance, deeper penetration into tissues and is perceived as more comfortable.
Myofascial pain syndrome (MPS) is a common form of chronic musculoskeletal pain that widely spread and contributing to a significant financial burden and job- related disability. It represents the most common disorder in patients with nonspecific chronic neck pain.The main characteristics of MPS include the presence of myofascial trigger points (MTrPs) which are defined as hyperirritable nodule in a taut band of skeletal muscle fibers which is palpable and tender during physical examination. Trigger points (TrPs) are usually seen in the upper fiber of trapezius. TrPs can be clinically classified as either active or latent. Active TrPs was defined as: MTrPs that refer pain during activity and during rest without any pressure. They prevent full muscle lengthening and induce their weakness. Latent TrPs was defined as: MTrPs that is painful only when palpated. Evidence on the effect of IFC on pain modulation is not confirmed up till now. This might be attributed to multiple factors such as limited number of studies, inappropriate use of the parameters or using single carrier frequency (4 KHz) in majority of studies and the physiological effects of all our modalities are dose dependent. Dose depends on details of parameters including frequency. For IFC, the carrier frequency of the current has been suggested as an important parameter to achieve the most effective hypoalgesic response. However, there remains no evidence to support the selection of one carrier frequency over another. Few studies were conducted to examine the effect of different carrier frequencies by comparing their individual effects. Further researches are needed to prove which carrier frequency is more effective in treatment. Therefore, this study will be conducted to compare the effect of different carrier frequencies of the IFC in the management of upper trapezius chronic TrPs.
- Conditions
- Upper Trapezius Trigger Points
- Being tested
- Stander treatment, Interferential current with carrier frequency 2 KHz, Interferential current with carrier frequency 4 KHz, Interferential current with carrier frequency 8 KHz, placebo interferential current
- Keywords
- Interferential current, Carrier frequency, Upper trapezius, Trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stander treatmentOther
Standard treatment will be (active cervical range of motion exercises, myofascial release to upper trapezius muscle and postural advices at home).
Interferential current with carrier frequency 2 KHzDevice
Interferential current treatment parameters will be as following; carrier frequency 2 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.
Interferential current with carrier frequency 4 KHzDevice
Interferential current treatment parameters will be as following; carrier frequency 4 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.
Interferential current with carrier frequency 8 KHzDevice
Interferential current treatment parameters will be as following; carrier frequency 8 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.
placebo interferential currentDevice
Interferential current intensity will not be raised.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment and interferential current with carrier frequency 2 KHz | Experimental | Standard treatment and interferential current with carrier frequency 2 KHz will be received three times a week for four weeks. Receives: Other: Stander treatment; Device: Interferential current with carrier frequency 2 KHz |
| Standard treatment and interferential current with carrier frequency 4 KHz | Experimental | Standard treatment and interferential current with carrier frequency 4 KHz will be received three times a week for four weeks. Receives: Other: Stander treatment; Device: Interferential current with carrier frequency 4 KHz |
| Standard treatment and interferential current with carrier frequency 8 KHz | Experimental | Standard treatment and interferential current with carrier frequency 8 KHz will be received three times a week for four weeks. Receives: Other: Stander treatment; Device: Interferential current with carrier frequency 8 KHz |
| Standard treatment and placebo interferential current | Placebo comparator | Standard treatment and placebo interferential current will be received three times a week for four weeks. Receives: Other: Stander treatment; Device: placebo interferential current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressure pain threshold
Pressure pain threshold will be measured by digital pressure algometer
Measured: Immediately after the end of the treatment
Secondary outcomes (7)
Change in Pressure pain threshold
Pressure pain threshold will be measured by digital pressure algometer
Measured: 12 weeks following the end of the treatment
Change in neck disability
Neck disability will be measured by Arabic neck disability index
Measured: Immediately after the end of the treatment
Change in neck disability
Neck disability will be measured by Arabic neck disability index
Measured: 12 weeks following the end of the treatment
Change in cervical range of motion
Cervical range of motion will be measured by cervical range of motion device
Measured: Immediately after the end of the treatment
Change in cervical range of motion
Cervical range of motion will be measured by cervical range of motion device
Measured: 12 weeks following the end of the treatment
Change in upper trapezius muscle activity
Muscle activity will be measured by electromyography in the form of root mean square
Measured: Immediately after the end of the treatment
Change in upper trapezius muscle activity
Muscle activity will be measured by electromyography in the form of root mean square
Measured: 12 weeks following the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Jun 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Trapezius Trigger PointsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial has four groups; three experimental and one group control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Samir Elsaid Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275634
- Sponsor's protocol ID
- P.T.REC/012/003591
- Status last verified
- May 2023
- First submitted
- 15 Feb 2022
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Venancio RC, Pelegrini S, Gomes DQ, Nakano EY, Liebano RE. Effects of carrier frequency of interferential current on pressure pain threshold and sensory comfort in humans. Arch Phys Med Rehabil. 2013 Jan;94(1):95-102. doi: 10.1016/j.apmr.2012.08.204. Epub 2012 Aug 23.
PubMed 22922327Correa JB, Costa LO, Oliveira NT, Lima WP, Sluka KA, Liebano RE. Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial. Eur J Pain. 2016 Nov;20(10):1653-1666. doi: 10.1002/ejp.889. Epub 2016 May 6.
PubMed 27150263
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Carrier Frequencies of Interferential Current on Upper Trapezius Myofascial Trigger Points: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05275634
- Acronym / sponsor ID
- P.T.REC/012/003591
- Conditions
- Upper Trapezius Trigger Points
- Keywords
- Interferential current, Carrier frequency, Upper trapezius, Trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of different carrier frequencies of interferential current on pressure pain threshold, neck disability, cervical range of motion and upper trapezius muscle activity when applied on upper trapezius chronic myofascial trigger points: Randomized Controlled Trial
Detailed description
Interferential current (IFC) is a medium frequency current derived from the interference of two symmetrical, but asynchronous alternating currents ranged from 1 to 10 KHz. The two main currents resulting in a single interference current with properties uniquely different from the two original currents.The lesser current of the two original currents is termed the carrier frequency and the interference current is called the beat frequency. A specific beat frequency can be obtained from several possible interference currents as long as the difference between the original currents is the same. For electro pain modulation, IFC is commonly used form of electrotherapy. It has the advantage of reducing the skin impedance, deeper penetration into tissues and is perceived as more comfortable.
Myofascial pain syndrome (MPS) is a common form of chronic musculoskeletal pain that widely spread and contributing to a significant financial burden and job- related disability. It represents the most common disorder in patients with nonspecific chronic neck pain.The main characteristics of MPS include the presence of myofascial trigger points (MTrPs) which are defined as hyperirritable nodule in a taut band of skeletal muscle fibers which is palpable and tender during physical examination. Trigger points (TrPs) are usually seen in the upper fiber of trapezius. TrPs can be clinically classified as either active or latent. Active TrPs was defined as: MTrPs that refer pain during activity and during rest without any pressure. They prevent full muscle lengthening and induce their weakness. Latent TrPs was defined as: MTrPs that is painful only when palpated. Evidence on the effect of IFC on pain modulation is not confirmed up till now. This might be attributed to multiple factors such as limited number of studies, inappropriate use of the parameters or using single carrier frequency (4 KHz) in majority of studies and the physiological effects of all our modalities are dose dependent. Dose depends on details of parameters including frequency. For IFC, the carrier frequency of the current has been suggested as an important parameter to achieve the most effective hypoalgesic response. However, there remains no evidence to support the selection of one carrier frequency over another. Few studies were conducted to examine the effect of different carrier frequencies by comparing their individual effects. Further researches are needed to prove which carrier frequency is more effective in treatment. Therefore, this study will be conducted to compare the effect of different carrier frequencies of the IFC in the management of upper trapezius chronic TrPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This trial has four groups; three experimental and one group control.
| Arm | Type | Receives |
|---|---|---|
| Standard treatment and interferential current with carrier frequency 2 KHz | Experimental | Other: Stander treatment, Device: Interferential current with carrier frequency 2 KHzStandard treatment and interferential current with carrier frequency 2 KHz will be received three times a week for four weeks. |
| Standard treatment and interferential current with carrier frequency 4 KHz | Experimental | Other: Stander treatment, Device: Interferential current with carrier frequency 4 KHzStandard treatment and interferential current with carrier frequency 4 KHz will be received three times a week for four weeks. |
| Standard treatment and interferential current with carrier frequency 8 KHz | Experimental | Other: Stander treatment, Device: Interferential current with carrier frequency 8 KHzStandard treatment and interferential current with carrier frequency 8 KHz will be received three times a week for four weeks. |
| Standard treatment and placebo interferential current | Placebo comparator | Other: Stander treatment, Device: placebo interferential currentStandard treatment and placebo interferential current will be received three times a week for four weeks. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages from18-29 years old with unilateral chronic myofascial trigger points in upper trapezius muscle will be included in this study.
- Participants have chronic myofascial trigger points if they have pain with pressure, local twitch response, jump sign, limited range of motion and referred pain lies over the lateral aspect of the upper trapezius fibers and superiorly to the ipsilateral occiput.
- Normal body mass index (BMI) from 18-24.9 Kg/m (BMI = body mass in kg divided by participant height in meters).
Key exclusion criteria (12 listed)
- Onset of pain less than 3 months
- History of whiplash injury
- History of cervical spine surgery
- Cervical radiculopathy or myelopathy and cervical disc lesion
- Cervical spondylolisthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stander treatmentStandard treatment will be (active cervical range of motion exercises, myofascial release to upper trapezius muscle and postural advices at home). | Other | Standard treatment and interferential current with carrier frequency 2 KHz, Standard treatment and interferential current with carrier frequency 4 KHz, Standard treatment and interferential current with carrier frequency 8 KHz, Standard treatment and placebo interferential current |
| Interferential current with carrier frequency 2 KHzInterferential current treatment parameters will be as following; carrier frequency 2 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level. | Device | Standard treatment and interferential current with carrier frequency 2 KHz |
| Interferential current with carrier frequency 4 KHzInterferential current treatment parameters will be as following; carrier frequency 4 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level. | Device | Standard treatment and interferential current with carrier frequency 4 KHz |
| Interferential current with carrier frequency 8 KHzInterferential current treatment parameters will be as following; carrier frequency 8 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level. | Device | Standard treatment and interferential current with carrier frequency 8 KHz |
| placebo interferential currentInterferential current intensity will not be raised. | Device | Standard treatment and placebo interferential current |
Primary outcome
Change in pressure pain threshold
Time frame: Immediately after the end of the treatment
Pressure pain threshold will be measured by digital pressure algometer
7 secondary outcomes
Change in Pressure pain threshold
Time frame: 12 weeks following the end of the treatment
Change in neck disability
Time frame: Immediately after the end of the treatment
Change in neck disability
Time frame: 12 weeks following the end of the treatment
Change in cervical range of motion
Time frame: Immediately after the end of the treatment
Change in cervical range of motion
Time frame: 12 weeks following the end of the treatment
Change in upper trapezius muscle activity
Time frame: Immediately after the end of the treatment
Change in upper trapezius muscle activity
Time frame: 12 weeks following the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 22922327Venancio RC, Pelegrini S, Gomes DQ, Nakano EY, Liebano RE. Effects of carrier frequency of interferential current on pressure pain threshold and sensory comfort in humans. Arch Phys Med Rehabil. 2013 Jan;94(1):95-102. doi: 10.1016/j.apmr.2012.08.204. Epub 2012 Aug 23.
- Background: PubMed 27150263Correa JB, Costa LO, Oliveira NT, Lima WP, Sluka KA, Liebano RE. Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial. Eur J Pain. 2016 Nov;20(10):1653-1666. doi: 10.1002/ejp.889. Epub 2016 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stander treatment, Interferential current with carrier frequency 2 KHz and Interferential current with carrier frequency 4 KHz in people with Upper Trapezius Trigger Points, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pressure pain threshold (time frame: Immediately after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.