Myofacial Pain SyndromeNCT06604962
Intramuscular Electrical Stimulation on Upper Trapezius With Trigger Points
A study testing IMES using IEP and IMES using CEP in people with Myofacial Pain Syndrome, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The prevalence of myofascial pain ranges from 30 to 93% and can result in sensorimotor and autonomic deficits. In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) and inverse electrode placement (IEP) are used to deliver electrical stimulation for pain modulation. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofacial Pain Syndrome
- What is being tested?
- IMES using IEP and IMES using CEP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Oct 2023to 25 Apr 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of myofascial trigger points in the upper trapezius (UT) muscle.
- Pressure pain threshold range between 0.5 to 1.5 kg/cm2
Who cannot join
- Shoulder conditions such as adhesive capsulitis, impingement syndrome, etc.
- Individuals with cervical radiculopathy,
- Nutritional deficiencies,
- Metabolic disorders such as obesity, diabetes mellitus,
- Participation in strength training,
- Cardiac pacemakers,
- History of migraine, epilepsy, electrophobia, needle phobia, skin diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intramuscular Electrical Stimulation Using Inverse Electrodes Placement on Electromyographic Activity and Pressure Pain Threshold in the Upper Trapezius With Trigger Points - A Randomized Controlled Trial
The prevalence of myofascial pain ranges from 30 to 93% and can result in sensorimotor and autonomic deficits. In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) and inverse electrode placement (IEP) are used to deliver electrical stimulation for pain modulation. However, Whether pain modulation can be achieved better from the intramuscular electrical stimulation (IMES) using the inverse electrode placement (IEP) or the conventional electrode placement (CEP) is still an open issue. Thus, current study's aim to compare the effects of IMES using IEP and CEP, and sham-IMES on pressure pain threshold (PPT), EMG activity, upper trapezius (UT) muscle length and pain severity in the UT muscle with myofascial trigger points (MTrPs) among young adults.
Read the detailed description
Myofascial trigger points (MTrPs) are defined as discrete areas of tenderness in taut bands of skeletal muscles that are painful. The upper trapezius (UT) muscle has been found to be often affected by MTrPs, which can result in altered sensory-motor function.
MTrPs may be related to pressure pain sensitivity and alterations in the upper trapezius muscle activity. A reduction in PPTs and increased electromyographic (EMG) activity of the UT muscle with MTrPs can be respectively interpreted as increased pain receptors sensitization and motor endplate activity.
In routine clinical practice, exercises, TrP injections, medications, and alternative therapies such as acupuncture dry needling (DN) are used to treat MTrPs. In recent years, some studies have reported that intramuscularly delivered electrical stimulation is a potential resource for the management of myofascial pain syndrome (MPS). Evidence from the literature suggests that IMES is effective in conditions such as adhesive capsulitis, MPS, and other non-traumatic musculoskeletal disorders.
In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) is used, in which an active cathode pole is placed in the peripheral target tissue and a reference anode is placed over the spinal level for peripheral pain modulation. Inverse electrode placement (IEP) is a alternate electrode placement method in which a cathode pole is placed over the spinal level and an anode pole over the distal parts of the limbs. IEP model experiments on MPS and non-traumatic shoulder pain disorders achieved significant clinical outcomes for shoulder pain and associated functional disabilities.
Although IMES is effective in reducing the pain threshold and changing EMG activity, the difference between the effects of IMES based on IEP and CEP on PPT and EMG activity (%MVIC) remains unknown. In line with previous study findings, this study hypothesized that IMES using IEP would achieve significant changes in the PPT, EMG activity, muscle length, and pain severity of the UT muscle with TrPs compared with IMES using CEP and Sham-IMES
- Conditions
- Myofacial Pain Syndrome
- Being tested
- IMES using IEP, IMES using CEP, Sham-IMES
- Keywords
- Myofascial trigger points, Electrical stimulation, Pressure pain threshold, Electromyography, Intramuscular stimulation, Intramuscular electrical stimulation
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMES using IEPProcedure or surgery
First group (n=12) received IMES using inverse electrode placement. The needle electrode inserted into the paraspinal region was connected to the active or cathode pole of the electrical stimulator. The reference or anode pole of the electrical stimulator was connected to the electrode that was inserted into the MTrP area of the UT muscle. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation
IMES using CEPProcedure or surgery
Second group (n=12) underwent IMES with conventional electrode placement. In this group, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. Needle electrodes were connected using alligator clip connectors. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation.
Sham-IMESOther
Third group (n=12) received sham-IMES. Similar to the experimental intervention groups, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. However, the delivered IMES was very minimal intensity
| Study group | Role | What they receive |
|---|---|---|
| Group I: IMES using IEP | Experimental | Participants in this group has allocated to the Intramuscular electrical stimulation using inverse electrode placement Receives: Procedure: IMES using IEP |
| Group II: IMES using CEP | Active comparator | Participants in this group has allocated to the Intramuscular electrical stimulation using conventional electrode placement Receives: Procedure: IMES using CEP |
| Group III: Sham-IMES | Sham comparator | Participants in this group has allocated to the Sham Intramuscular electrical stimulation Receives: Other: Sham-IMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT)
Pressure algometry, a device that applies an increasing force over a limited constant surface, allows the quantification of the minimum pressure, which induces pain or discomfort, indicated as the PPT. PPT in the UT muscle area was assessed using a pressure algometer (JTECH Medical Commander Echo-Algometer with Console, Serial No-0d219167) by an experienced physiotherapist blinded to the intervention groups
Measured: Day one before the treatment, day one post treatment and day three follow-up
Upper trapezius' Surface Electromyographic activity
The surface Electromyography (EMG) recording during the experimental condition and Maximum Voluntary Isometric Contraction (MVIC) of the UT muscle was performed using a BTS FREEEMG 1000 system (BTS Bioengineering, Milan, Italy) in three sessions: day one before and after treatment and day three follow-up. EMG data collected during the MVIC of the right-side UT muscle was used as a reference value to normalize the EMG activity of the experimental condition.
Measured: Day one before the treatment, day one post treatment and day three follow-up
Secondary outcomes (2)
Pain severity
The severity of Upper Trapezius muscle pain was assessed using a visual analog scale (VAS: 0-10 cm, where 0 indicates no pain and 10 indicates severe pain), which has high intra- and inter-rater reliability to measure pain severity.
Measured: Day one before the treatment, day one post treatment and day three follow-up
Upper trapezius' muscle length
The upper trapezius length test was used to assess the UT muscle length. This involves gently lifting the patient\'s head off the table, flexing the neck slightly to take the upper trapezius to a lengthened position, and assessing the range of motion and any restrictions or discomfort experienced by the patient during this maneuver. This test is a valid assessment tool for identifying restrictions or tightness in the upper trapezius muscle. The reliability coefficients for muscle length were generally higher for the healthy group compared to the neck pain group, with ICC values ranging from 0.19 to 0.93 for the neck pain group and 0.40 to 0.93 for the healthy group
Measured: Day one before the treatment, day one post treatment and day three follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start28 Oct 2023
- Primary completion30 Mar 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofacial Pain SyndromeStudies of the same condition, open and under way.
- 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 is an experimental study to study the effects of intramuscular electrical stimulation using different electrode placements over sham comparator group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Sul de Santa Catarina
- Responsible party
- Sponsor
- Investigators
- Ramprasad Muthukrishnan, PhD, Study chair, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604962
- Sponsor's protocol ID
- IRB-COHS-FAC-28-OCT-2023
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shanmugam S. Inverse Electrode Placement May Help to Improve Electrotherapeutic Effects in the Field of Chronic Pain Management. Korean J Pain. 2016 Jul;29(3):202-4. doi: 10.3344/kjp.2016.29.3.202. Epub 2016 Jul 1. No abstract available.
PubMed 27413488Shanmugam S, Mathias L, Thakur A, Kumar D. Effects of Intramuscular Electrical Stimulation Using Inversely Placed Electrodes on Myofascial Pain Syndrome in the Shoulder: A Case Series. Korean J Pain. 2016 Apr;29(2):136-40. doi: 10.3344/kjp.2016.29.2.136. Epub 2016 Apr 1.
PubMed 27103970Shanmugam S, Mathias L, Manickaraj N, Kumar KUD, Kandakurti PK, Dorairaj SK, Muthukrishnan R. Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial. Int J Surg Protoc. 2021 May 18;25(1):71-83. doi: 10.29337/ijsp.25.
PubMed 34056148
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Electrical Stimulation Using Inverse Electrodes Placement on Electromyographic Activity and Pressure Pain Threshold in the Upper Trapezius With Trigger Points - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06604962
- Acronym / sponsor ID
- IRB-COHS-FAC-28-OCT-2023
- Conditions
- Myofacial Pain Syndrome
- Keywords
- Myofascial trigger points, Electrical stimulation, Pressure pain threshold, Electromyography, Intramuscular stimulation, Intramuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Collaborators
- Universidade do Sul de Santa Catarina
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 20 Sep 2024 (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.
The prevalence of myofascial pain ranges from 30 to 93% and can result in sensorimotor and autonomic deficits. In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) and inverse electrode placement (IEP) are used to deliver electrical stimulation for pain modulation. However, Whether pain modulation can be achieved better from the intramuscular electrical stimulation (IMES) using the inverse electrode placement (IEP) or the conventional electrode placement (CEP) is still an open issue. Thus, current study's aim to compare the effects of IMES using IEP and CEP, and sham-IMES on pressure pain threshold (PPT), EMG activity, upper trapezius (UT) muscle length and pain severity in the UT muscle with myofascial trigger points (MTrPs) among young adults.
Detailed description
Myofascial trigger points (MTrPs) are defined as discrete areas of tenderness in taut bands of skeletal muscles that are painful. The upper trapezius (UT) muscle has been found to be often affected by MTrPs, which can result in altered sensory-motor function.
MTrPs may be related to pressure pain sensitivity and alterations in the upper trapezius muscle activity. A reduction in PPTs and increased electromyographic (EMG) activity of the UT muscle with MTrPs can be respectively interpreted as increased pain receptors sensitization and motor endplate activity.
In routine clinical practice, exercises, TrP injections, medications, and alternative therapies such as acupuncture dry needling (DN) are used to treat MTrPs. In recent years, some studies have reported that intramuscularly delivered electrical stimulation is a potential resource for the management of myofascial pain syndrome (MPS). Evidence from the literature suggests that IMES is effective in conditions such as adhesive capsulitis, MPS, and other non-traumatic musculoskeletal disorders.
In routine neuromuscular electrical stimulation, conventional electrode placement (CEP) is used, in which an active cathode pole is placed in the peripheral target tissue and a reference anode is placed over the spinal level for peripheral pain modulation. Inverse electrode placement (IEP) is a alternate electrode placement method in which a cathode pole is placed over the spinal level and an anode pole over the distal parts of the limbs. IEP model experiments on MPS and non-traumatic shoulder pain disorders achieved significant clinical outcomes for shoulder pain and associated functional disabilities.
Although IMES is effective in reducing the pain threshold and changing EMG activity, the difference between the effects of IMES based on IEP and CEP on PPT and EMG activity (%MVIC) remains unknown. In line with previous study findings, this study hypothesized that IMES using IEP would achieve significant changes in the PPT, EMG activity, muscle length, and pain severity of the UT muscle with TrPs compared with IMES using CEP and Sham-IMES
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This is an experimental study to study the effects of intramuscular electrical stimulation using different electrode placements over sham comparator group
| Arm | Type | Receives |
|---|---|---|
| Group I: IMES using IEP | Experimental | Procedure: IMES using IEPParticipants in this group has allocated to the Intramuscular electrical stimulation using inverse electrode placement |
| Group II: IMES using CEP | Active comparator | Procedure: IMES using CEPParticipants in this group has allocated to the Intramuscular electrical stimulation using conventional electrode placement |
| Group III: Sham-IMES | Sham comparator | Other: Sham-IMESParticipants in this group has allocated to the Sham Intramuscular electrical stimulation |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of myofascial trigger points in the upper trapezius (UT) muscle.
- Pressure pain threshold range between 0.5 to 1.5 kg/cm2
Key exclusion criteria (7 listed)
- Shoulder conditions such as adhesive capsulitis, impingement syndrome, etc.
- Individuals with cervical radiculopathy,
- Nutritional deficiencies,
- Metabolic disorders such as obesity, diabetes mellitus,
- Participation in strength training,
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 |
|---|---|---|
| IMES using IEPFirst group (n=12) received IMES using inverse electrode placement. The needle electrode inserted into the paraspinal region was connected to the active or cathode pole of the electrical stimulator. The reference or anode pole of the electrical stimulator was connected to the electrode that was inserted into the MTrP area of the UT muscle. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation | Procedure or surgery | Group I: IMES using IEP |
| IMES using CEPSecond group (n=12) underwent IMES with conventional electrode placement. In this group, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. Needle electrodes were connected using alligator clip connectors. The muscle was stimulated for 10 min with a tolerable intensity in a single session to induce muscle relaxation. | Procedure or surgery | Group II: IMES using CEP |
| Sham-IMESThird group (n=12) received sham-IMES. Similar to the experimental intervention groups, the cathode pole of the stimulator was connected to the needle inserted into the UT muscle, and the anode pole was connected to the needles of the paraspinal region of the cervical spine. However, the delivered IMES was very minimal intensity | Other | Group III: Sham-IMES |
Primary outcome
Pressure pain threshold (PPT)
Time frame: Day one before the treatment, day one post treatment and day three follow-up
Pressure algometry, a device that applies an increasing force over a limited constant surface, allows the quantification of the minimum pressure, which induces pain or discomfort, indicated as the PPT. PPT in the UT muscle area was assessed using a pressure algometer (JTECH Medical Commander Echo-Algometer with Console, Serial No-0d219167) by an experienced physiotherapist blinded to the intervention groups
Upper trapezius' Surface Electromyographic activity
Time frame: Day one before the treatment, day one post treatment and day three follow-up
The surface Electromyography (EMG) recording during the experimental condition and Maximum Voluntary Isometric Contraction (MVIC) of the UT muscle was performed using a BTS FREEEMG 1000 system (BTS Bioengineering, Milan, Italy) in three sessions: day one before and after treatment and day three follow-up. EMG data collected during the MVIC of the right-side UT muscle was used as a reference value to normalize the EMG activity of the experimental condition.
2 secondary outcomes
Pain severity
Time frame: Day one before the treatment, day one post treatment and day three follow-up
Upper trapezius' muscle length
Time frame: Day one before the treatment, day one post treatment and day three follow-up
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 1 Oct 2024.
- Background: PubMed 27413488Shanmugam S. Inverse Electrode Placement May Help to Improve Electrotherapeutic Effects in the Field of Chronic Pain Management. Korean J Pain. 2016 Jul;29(3):202-4. doi: 10.3344/kjp.2016.29.3.202. Epub 2016 Jul 1. No abstract available.
- Background: PubMed 27103970Shanmugam S, Mathias L, Thakur A, Kumar D. Effects of Intramuscular Electrical Stimulation Using Inversely Placed Electrodes on Myofascial Pain Syndrome in the Shoulder: A Case Series. Korean J Pain. 2016 Apr;29(2):136-40. doi: 10.3344/kjp.2016.29.2.136. Epub 2016 Apr 1.
- Background: PubMed 34056148Shanmugam S, Mathias L, Manickaraj N, Kumar KUD, Kandakurti PK, Dorairaj SK, Muthukrishnan R. Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial. Int J Surg Protoc. 2021 May 18;25(1):71-83. doi: 10.29337/ijsp.25.
- Individual participant dataSharing planned: No
Related trials for Myofacial Pain Syndrome
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Recruiting
Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Myofacial Pain Syndrome
Recruiting
Massage Gun vs Deep Friction Massage for Upper Trapezius Trigger Points
Myofacial Trigger Points of Upper Trapezius
Recruiting
Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain
Myofacial Pain Syndrome, Local Myalgia
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.
Ramprasad Muthukrishnan, PhD study chair
Gulf Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMES using IEP and IMES using CEP in people with Myofacial Pain Syndrome, run by Gulf Medical University at 1 site in United Arab Emirates.
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 2 inclusion and 7 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 1 Oct 2024. 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 United Arab Emirates. 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?
Pressure pain threshold (PPT) (time frame: Day one before the treatment, day one post treatment and day three follow-up). The study lists 2 primary outcomes in all. 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 NCT06604962, which also lists 3 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 1 Oct 2024.