Myofascial Pain SyndromesNCT04645095
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?
A study testing Transcutaneous electrical nerve stimulation and Hot pack in people with Myofascial Pain Syndromes, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Transcutaneous electrical nerve stimulation and Hot pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2017to 1 Mar 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons
Who cannot join
- The onset of symptoms is less than 3 months
- Severe cervical disc hernia, radiculopathy or myelopathy
- Stage 3-4 cervical degeneration
- Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease
- Cardiac pacemaker
- Diagnosed with fibromyalgia syndrome
Show all 11Show fewer
- Kyphoscoliosis
- Acute trauma history
- Having had previous brain or shoulder surgery
- Injections for MAS and / or physiotherapy programs in the last 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome? A Randomized Controlled Trial
The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.
Read the detailed description
Myofascial pain syndrome (MAS) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. Transcutaneous electrical nerve stimulation (TENS) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. Knowledge on how modulation parameters such as frequency, wave width and form alter TENS activity are limited.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Transcutaneous electrical nerve stimulation, Hot pack
- Keywords
- Myofascial Pain Syndromes, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called TENS
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Hot packDevice
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional TENS | Active comparator | Frequency:80 Hz, duration:100 μs Receives: Device: Transcutaneous electrical nerve stimulation; Device: Hot pack |
| Burst TENS | Active comparator | Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz Receives: Device: Transcutaneous electrical nerve stimulation; Device: Hot pack |
| Modulated TENS | Active comparator | Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs Receives: Device: Transcutaneous electrical nerve stimulation; Device: Hot pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Number of trigger points in the upper back region
using number
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Pressure pain
using algometer (kg/cm2)
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Neck joint range of motion
using double inclinometer
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Disability
using Modified Neck Disability Index
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start5 May 2017
- Primary completion6 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birkan Sonel Tur, Ankara University
- Investigators
- Birkan Sonel Tur, Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645095
- Sponsor's protocol ID
- 10-427-16
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04645095
- Acronym / sponsor ID
- 10-427-16
- Conditions
- Myofascial Pain Syndromes
- Keywords
- Myofascial Pain Syndromes, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Nov 2020 (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 aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.
Detailed description
Myofascial pain syndrome (MAS) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. Transcutaneous electrical nerve stimulation (TENS) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. Knowledge on how modulation parameters such as frequency, wave width and form alter TENS activity are limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional TENS | Active comparator | Device: Transcutaneous electrical nerve stimulation, Device: Hot packFrequency:80 Hz, duration:100 μs |
| Burst TENS | Active comparator | Device: Transcutaneous electrical nerve stimulation, Device: Hot packFrequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz |
| Modulated TENS | Active comparator | Device: Transcutaneous electrical nerve stimulation, Device: Hot packFrequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons
Key exclusion criteria (11 listed)
- The onset of symptoms is less than 3 months
- Severe cervical disc hernia, radiculopathy or myelopathy
- Stage 3-4 cervical degeneration
- Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease
- Cardiac pacemaker
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulationAlso: TENSAll groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions. | Device | Burst TENS, Conventional TENS, Modulated TENS |
| Hot packAll groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions. | Device | Burst TENS, Conventional TENS, Modulated TENS |
Primary outcome
Pain intensity
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Number of trigger points in the upper back region
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using number
Pressure pain
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using algometer (kg/cm2)
Neck joint range of motion
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using double inclinometer
Disability
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using Modified Neck Disability Index
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 27 Nov 2020.
Related trials for Myofascial Pain Syndromes
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
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.
Birkan Sonel Tur, Prof. principal investigator
Ankara 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 Transcutaneous electrical nerve stimulation and Hot pack in people with Myofascial Pain Syndromes, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 11 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 27 Nov 2020. 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 Turkey (Türkiye). 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. 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?
Pain intensity (time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.