Neck PainNCT05367752
Effects of MR With TENS Conductive Glove in Adults With Neck Myofascial Syndrome.
A study testing Myofascial release with TENS conductive glove, Myofascial release without TENS conductive glove and Conventional TENS in people with Neck Pain, run by International Hellenic University at 1 site in Greece.
Trial summary
Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release and the application of TENS currents to the painful points of the neck muscles have been… Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Myofascial release with TENS conductive glove, Myofascial release without TENS conductive glove and Conventional TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2022to 15 Jun 2022
- 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 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of at least one trigger point in the upper part of the trapezius muscle
- Age range 22-60 years
- Scoring 10% or higher on the Neck Disability Index
- Scoring of 20mm or more on the Visual Analogue Scale of pain at initial evaluation
- Written consent to participate in the study
Who cannot join
- History of acute neck injury
- Sensory disorders in the neck area
- Diagnosis with a serious illness (cancer, severe osteoporosis, infectious or inflammatory processes, fractures, congenital anomalies)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
Thessaloniki, Sindos Thessaloníki, 57 400
About this study
Official title: Short-term Effects of Myofascial Release With TENS Conductive Glove in Pain, Range of Motion and Functional Disability in Adults With Neck Myofascial Syndrome: A Randomized Clinical Trial Study
Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release and the application of TENS currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck. 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of myofascial release with conductive TENS glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional ability with the "Neck Disability Index" (NDI) questionnaire.
Read the detailed description
Background: Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release (MR) and the application of transcutaneous electrical nerve stimulation (TENS) currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck.
Aim: To study the efficacy of the combination of MR and the simultaneous application of TENS currents in the painful points of the upper part of the trapezius muscle. The myofascial release protocol will be applied with a conductive glove, which will be connected to a TENS device so that the physiotherapist's hand can be used simultaneously as a mobile electrode.
Method: 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of MR with a TENS conductive glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional disability with the "Neck Disability Index" (NDI) questionnaire. For the statistical analysis of the results, a two-way ANOVA with repeated measurements will be applied.
Expected results: The combination protocol proposed in this clinical study combines the beneficial effects of TENS with the benefits of MR. For this reason, this combination is expected to be more effective than their individual application in improving the clinical picture of adults with myofascial neck syndrome.
- Conditions
- Neck Pain
- Being tested
- Myofascial release with TENS conductive glove, Myofascial release without TENS conductive glove, Conventional TENS, Sham TENS
- Keywords
- Neck Pain, Myofascial trigger points, Myofascial release, Transcutaneous electrical nerve stimulation, Physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial release with TENS conductive gloveOther
Before each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle.
Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles.
Myofascial release without TENS conductive gloveOther
Before each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle.
Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles.
Conventional TENSOther
Two 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021)
Sham TENSOther
Two 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Myofascial release with TENS conductive glove | Experimental | Participants allocated to this group received six sessions of a myofascial release protocol with a TENS conductive glove applying a TENS current of 120Hz frequency through an electrotherapy device. Receives: Other: Myofascial release with TENS conductive glove |
| Group 2: Myofascial release without TENS conductive glove | Experimental | Participants allocated to this group received the same myofascial release protocol with group 1 without the TENS conductive glove. Receives: Other: Myofascial release without TENS conductive glove |
| Group 3: Conventional TENS | Experimental | Participants allocated to this group received the application of a conventional TENS current. Receives: Other: Conventional TENS |
| Control: Sham TENS | Active comparator | Participants allocated to this group received the same TENS treatment with group 3, but with the current intensity set to zero to ensure that they received no current. Receives: Other: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain intensity with visual analogue scale (VAS)
VAS is a card with an uncalibrated scale ranging from 0-100 mm on the one side (with zero representing no pain and 100 representing the worst pain in life) with each millimeter representing one pain level. The patient subjectively estimated his or her pain level by marking a vertical line on the uncalibrated scale between zero and one hundred. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
Measured: pre-treatment, week: 1, 3, 7
Changes in Pressure Pain threshold with pressure algometry
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.
Measured: pre-treatment, week: 1, 3, 7
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Changes in functional capacity with the Greek Version of Neck disability index questionnaire It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.
Measured: pre-treatment, week: 1, 3, 7
Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees. To measure the right and left range of flexion, a long universal goniometer will be placed at the top of the head. The arms of the goniometer will be positioned in such a way that they form a right angle with each other. One arm should face forward, while the second should look to the side towards the side of the turn to be made by the examinee, so that the goniometer reading at the beginning of the measurement is 90°. The patient will then make a turn while the examiner follows the movement without displacing the center of the goniometer.
Measured: pre-treatment, week: 1, 3, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Apr 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- An assessor-blind randomized control trial with a duration of three weeks and a one-month follow up will be performed in 80 adults with neck pain due to the presence of trigger points on the upper part of trapezius muscle. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). In the first group, a combination therapy of myofascial release with conductive TENS gloves will be applied, in the second group the same protocol of myofascial release without conductive gloves, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
- Investigators
- Paris Iakovidis, PhD, Study director, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367752
- Sponsor's protocol ID
- EC-03/2022
- Status last verified
- Aug 2022
- First submitted
- 5 May 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Myofascial Release With TENS Conductive Glove in Pain, Range of Motion and Functional Disability in Adults With Neck Myofascial Syndrome: A Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT05367752
- Acronym / sponsor ID
- EC-03/2022
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Myofascial trigger points, Myofascial release, Transcutaneous electrical nerve stimulation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 10 May 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.
Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release and the application of TENS currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck. 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of myofascial release with conductive TENS glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional ability with the "Neck Disability Index" (NDI) questionnaire.
Detailed description
Background: Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release (MR) and the application of transcutaneous electrical nerve stimulation (TENS) currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck.
Aim: To study the efficacy of the combination of MR and the simultaneous application of TENS currents in the painful points of the upper part of the trapezius muscle. The myofascial release protocol will be applied with a conductive glove, which will be connected to a TENS device so that the physiotherapist's hand can be used simultaneously as a mobile electrode.
Method: 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of MR with a TENS conductive glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional disability with the "Neck Disability Index" (NDI) questionnaire. For the statistical analysis of the results, a two-way ANOVA with repeated measurements will be applied.
Expected results: The combination protocol proposed in this clinical study combines the beneficial effects of TENS with the benefits of MR. For this reason, this combination is expected to be more effective than their individual application in improving the clinical picture of adults with myofascial neck syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- An assessor-blind randomized control trial with a duration of three weeks and a one-month follow up will be performed in 80 adults with neck pain due to the presence of trigger points on the upper part of trapezius muscle. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). In the first group, a combination therapy of myofascial release with conductive TENS gloves will be applied, in the second group the same protocol of myofascial release without conductive gloves, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Myofascial release with TENS conductive glove | Experimental | Other: Myofascial release with TENS conductive gloveParticipants allocated to this group received six sessions of a myofascial release protocol with a TENS conductive glove applying a TENS current of 120Hz frequency through an electrotherapy device. |
| Group 2: Myofascial release without TENS conductive glove | Experimental | Other: Myofascial release without TENS conductive gloveParticipants allocated to this group received the same myofascial release protocol with group 1 without the TENS conductive glove. |
| Group 3: Conventional TENS | Experimental | Other: Conventional TENSParticipants allocated to this group received the application of a conventional TENS current. |
| Control: Sham TENS | Active comparator | Other: Sham TENSParticipants allocated to this group received the same TENS treatment with group 3, but with the current intensity set to zero to ensure that they received no current. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of at least one trigger point in the upper part of the trapezius muscle
- Age range 22-60 years
- Scoring 10% or higher on the Neck Disability Index
- Scoring of 20mm or more on the Visual Analogue Scale of pain at initial evaluation
- Written consent to participate in the study
Key exclusion criteria (3 listed)
- History of acute neck injury
- Sensory disorders in the neck area
- Diagnosis with a serious illness (cancer, severe osteoporosis, infectious or inflammatory processes, fractures, congenital anomalies)
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 |
|---|---|---|
| Myofascial release with TENS conductive gloveBefore each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle. Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles. | Other | Group 1: Myofascial release with TENS conductive glove |
| Myofascial release without TENS conductive gloveBefore each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle. Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles. | Other | Group 2: Myofascial release without TENS conductive glove |
| Conventional TENSTwo 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021) | Other | Group 3: Conventional TENS |
| Sham TENSTwo 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021) | Other | Control: Sham TENS |
Primary outcome
Changes in neck pain intensity with visual analogue scale (VAS)
Time frame: pre-treatment, week: 1, 3, 7
VAS is a card with an uncalibrated scale ranging from 0-100 mm on the one side (with zero representing no pain and 100 representing the worst pain in life) with each millimeter representing one pain level. The patient subjectively estimated his or her pain level by marking a vertical line on the uncalibrated scale between zero and one hundred. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
Changes in Pressure Pain threshold with pressure algometry
Time frame: pre-treatment, week: 1, 3, 7
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Time frame: pre-treatment, week: 1, 3, 7
Changes in functional capacity with the Greek Version of Neck disability index questionnaire It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.
Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
Time frame: pre-treatment, week: 1, 3, 7
Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees. To measure the right and left range of flexion, a long universal goniometer will be placed at the top of the head. The arms of the goniometer will be positioned in such a way that they form a right angle with each other. One arm should face forward, while the second should look to the side towards the side of the turn to be made by the examinee, so that the goniometer reading at the beginning of the measurement is 90°. The patient will then make a turn while the examiner follows the movement without displacing the center of the goniometer.
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 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Paris Iakovidis, PhD study director
International Hellenic 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 Myofascial release with TENS conductive glove, Myofascial release without TENS conductive glove and Conventional TENS in people with Neck Pain, run by International Hellenic University at 1 site in Greece.
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 5 inclusion and 3 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 4 Aug 2022. 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 Greece. 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?
Changes in neck pain intensity with visual analogue scale (VAS) (time frame: pre-treatment, week: 1, 3, 7). The study lists 4 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 4 Aug 2022.