Neck PainNCT05727462
Effects of Manual Therapy With TECAR in Woman With Chronic Neck Pain
A study testing Manual Therapy with TECAR and Manual Therapy without TECAR in people with Neck Pain, run by International Hellenic University at 1 site in Greece.
Trial summary
The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy, utilizing two specialized anti-static electrode bracelets. Read more about this study
- Who is it for?
- Ages 22 to 60 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual Therapy with TECAR and Manual Therapy without TECAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2023to 1 Mar 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 22 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with chronic neck pain lasting at least three months Presence of at least one active or latent trigger point in the upper trapezius muscle Numerical Rating Pain Scale score greater than 3 Written consent to participate in the study
Who cannot join
- Participation in any form of treatment in the past three months (e.g., physiotherapy, massage, local anesthetic injections) History of neck trauma and/or surgery in the neck region Paresthesia in the neck area Implanted pacemaker Cancer Pregnancy Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's disease), epilepsy, or history of psychiatric disorders
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: Effects of a Protocol of Soft Tissue Mobilization Techniques With or Without TECAR Treatment on Pain, Local Sensitivity, Neck Range of Motion, and Functional Ability in Woman With Chronic Neck Pain: A Randomized Clinical Trial
The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy, utilizing two specialized anti-static electrode bracelets. A total of 80 women with upper trapezius trigger points and neck pain persisting for more than 12 weeks will be randomly assigned to two groups. In the first group, combined treatment involving manual techniques and two TECAR anti-static electrode bracelets will be administered, while in the second group, the same protocol will be followed without the electrode bracelets. All participants will receive a total of 15 treatments over five weeks, with a follow-up assessment six months post-treatment. Pain will be measured using the Numerical Pain Rating Scale (NPRS), and pain thresholds at the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer. Additionally, neck range of motion will be assessed with a goniometer, and functional ability will be evaluated using the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.
Read the detailed description
Background: Chronic neck pain is defined as neck pain lasting more than 12 weeks and is often accompanied by painful trigger points in the neck muscles. The use of manual techniques, such as myofascial release and ischemic compression on painful points in the neck muscles, has been shown to reduce pain and improve functional ability and neck range of motion in individuals with chronic neck pain.
Aim: The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy using two specialized anti-static electrode bracelets.
Method: Eighty women with upper trapezius trigger points and neck pain symptoms persisting for more than 12 weeks will be randomly assigned to two groups. The first group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the second group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over five weeks, with a follow-up assessment after six months. Pain will be measured using the Numerical Pain Rating Scale (NPRS), pressure pain threshold (PPT) of the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer, neck range of motion (ROM) will be assessed using a goniometer, and functional ability will be measured with the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.
Expected Results: Modern TECAR devices, through special resistive bracelet electrodes, allow the therapist's hand to function as a mobile electrode. This enables the simultaneous effect of both therapeutic modalities-manual techniques and high-frequency current. Therefore, we expect the combination to be more effective than manual techniques alone in improving the clinical profile of adult women with chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- Manual Therapy with TECAR, Manual Therapy without TECAR
- Keywords
- Neck Pain, Myofascial trigger points, Manual Therapy, TECAR, 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.
Manual Therapy with TECAROther
The following myofascial release techniques will be applied:
Myofascial release of the upper trapezius Gross stretch, vertical gross stretch, and focused stretch of the upper trapezius Myofascial release at the cranial base Gross release of the sternocleidomastoid muscle
Additionally, the following ischemic compression technique will be applied:
Ischemic compression on the upper trapezius muscle Manual therapy manipulations will be administered in combination with a capacitive conventional electrode and two special electrode bracelets that turn the therapist's hands into anti-static electrodes. High-frequency currents will be applied at frequencies of 300 kHz, 500 kHz, and 1 MHz, with a flexible self-adhesive grounding electrode placed on the thoracic spine for reference.
Manual Therapy without TECAROther
Participants in this group will follow the same manual protocol as the first group, without the application of high-frequency current. Each manual therapy session will begin with a ten-minute preparation involving light massage and stretching. The massage will include the effleurage technique, followed by petrissage and kneading, focusing on the cervical and thoracic areas, particularly the upper trapezius, suboccipital region, and cervical paraspinal muscles. Stretching will be applied to the upper trapezius, levator scapulae, and sternocleidomastoid muscles.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy with TECAR | Experimental | Participants allocated to this group received 15 sessions of a manual therapy protocol applied by two resistive TECAR bracelet electrodes (one in each hand). Receives: Other: Manual Therapy with TECAR |
| Manual Therapy without TECAR bracelet electrodes | Active comparator | Participants allocated to this group received the same Manual Therapy protocol without the resistive TECAR bracelet electrodes Receives: Other: Manual Therapy without TECAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity
Measured: pre-treatment, week 5, 6-month follow-up
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Pressure pain threshold (PPT) is defined as the minimum amount of pressure that induces pain. PPT was assessed using a digital algometer. Measurements were taken over the upper border of the trapezius muscle, midway between the midline and the lateral border of the acromion, as well as in the suboccipital area, 2 cm lateral to the spinous process of the axis. The metal rod of the algometer was positioned vertically on each site, and the examiner applied gradually increasing pressure at a rate of 1 kg/s. PPT was recorded in kg/cm².
Measured: pre-treatment, week 5, 6-month follow-up
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
It is a self-reported, ten-item scale, with each item assessing different aspects of neck pain complaints. Most items relate to restrictions in activities of daily living, and each item is rated on a scale of 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score ranges from 0 to 50. The Neck Disability Index (NDI) is well-supported in the literature and is the most commonly used tool for reporting neck pain.
Measured: pre-treatment, week 5, 6-month follow-up
Changes in Cervical Range of Motion through goniometry
Active cervical range of motion was measured using two types of goniometers: two bubble inclinometers and a large-scale universal goniometer. Measurements included active cervical flexion, extension, rotation, and side bending, with participants seated in an upright position. Range of motion was recorded in degrees.
Measured: pre-treatment, week 5, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start15 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 controlled trial lasting five weeks, with a six-month follow-up, will be conducted on 80 adult women with chronic neck pain and at least one trigger point in the upper trapezius muscle. Participants will be randomly allocated into two groups of 40 each (intervention and control). The intervention group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the control group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over the five-week period.
- 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, Ph.D, Study chair, Department of Physiotherapy, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727462
- Sponsor's protocol ID
- EC-03/2023
- Status last verified
- Nov 2024
- First submitted
- 5 Feb 2023
- Last updated
- 8 Nov 2024
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Protocol of Soft Tissue Mobilization Techniques With or Without TECAR Treatment on Pain, Local Sensitivity, Neck Range of Motion, and Functional Ability in Woman With Chronic Neck Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05727462
- Acronym / sponsor ID
- EC-03/2023
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Myofascial trigger points, Manual Therapy, TECAR, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Feb 2023 (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 our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy, utilizing two specialized anti-static electrode bracelets. A total of 80 women with upper trapezius trigger points and neck pain persisting for more than 12 weeks will be randomly assigned to two groups. In the first group, combined treatment involving manual techniques and two TECAR anti-static electrode bracelets will be administered, while in the second group, the same protocol will be followed without the electrode bracelets. All participants will receive a total of 15 treatments over five weeks, with a follow-up assessment six months post-treatment. Pain will be measured using the Numerical Pain Rating Scale (NPRS), and pain thresholds at the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer. Additionally, neck range of motion will be assessed with a goniometer, and functional ability will be evaluated using the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.
Detailed description
Background: Chronic neck pain is defined as neck pain lasting more than 12 weeks and is often accompanied by painful trigger points in the neck muscles. The use of manual techniques, such as myofascial release and ischemic compression on painful points in the neck muscles, has been shown to reduce pain and improve functional ability and neck range of motion in individuals with chronic neck pain.
Aim: The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy using two specialized anti-static electrode bracelets.
Method: Eighty women with upper trapezius trigger points and neck pain symptoms persisting for more than 12 weeks will be randomly assigned to two groups. The first group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the second group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over five weeks, with a follow-up assessment after six months. Pain will be measured using the Numerical Pain Rating Scale (NPRS), pressure pain threshold (PPT) of the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer, neck range of motion (ROM) will be assessed using a goniometer, and functional ability will be measured with the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.
Expected Results: Modern TECAR devices, through special resistive bracelet electrodes, allow the therapist's hand to function as a mobile electrode. This enables the simultaneous effect of both therapeutic modalities-manual techniques and high-frequency current. Therefore, we expect the combination to be more effective than manual techniques alone in improving the clinical profile of adult women with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An assessor-blind randomized controlled trial lasting five weeks, with a six-month follow-up, will be conducted on 80 adult women with chronic neck pain and at least one trigger point in the upper trapezius muscle. Participants will be randomly allocated into two groups of 40 each (intervention and control). The intervention group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the control group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over the five-week period.
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy with TECAR | Experimental | Other: Manual Therapy with TECARParticipants allocated to this group received 15 sessions of a manual therapy protocol applied by two resistive TECAR bracelet electrodes (one in each hand). |
| Manual Therapy without TECAR bracelet electrodes | Active comparator | Other: Manual Therapy without TECARParticipants allocated to this group received the same Manual Therapy protocol without the resistive TECAR bracelet electrodes |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with chronic neck pain lasting at least three months Presence of at least one active or latent trigger point in the upper trapezius muscle Numerical Rating Pain Scale score greater than 3 Written consent to participate in the study
Key exclusion criteria (1 listed)
- Participation in any form of treatment in the past three months (e.g., physiotherapy, massage, local anesthetic injections) History of neck trauma and/or surgery in the neck region Paresthesia in the neck area Implanted pacemaker Cancer Pregnancy Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's disease), epilepsy, or history of psychiatric disorders
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 |
|---|---|---|
| Manual Therapy with TECARThe following myofascial release techniques will be applied: Myofascial release of the upper trapezius Gross stretch, vertical gross stretch, and focused stretch of the upper trapezius Myofascial release at the cranial base Gross release of the sternocleidomastoid muscle Additionally, the following ischemic compression technique will be applied: Ischemic compression on the upper trapezius muscle Manual therapy manipulations will be administered in combination with a capacitive conventional electrode and two special electrode bracelets that turn the therapist's hands into anti-static electrodes. High-frequency currents will be applied at frequencies of 300 kHz, 500 kHz, and 1 MHz, with a flexible self-adhesive grounding electrode placed on the thoracic spine for reference. | Other | Manual Therapy with TECAR |
| Manual Therapy without TECARParticipants in this group will follow the same manual protocol as the first group, without the application of high-frequency current. Each manual therapy session will begin with a ten-minute preparation involving light massage and stretching. The massage will include the effleurage technique, followed by petrissage and kneading, focusing on the cervical and thoracic areas, particularly the upper trapezius, suboccipital region, and cervical paraspinal muscles. Stretching will be applied to the upper trapezius, levator scapulae, and sternocleidomastoid muscles. | Other | Manual Therapy without TECAR bracelet electrodes |
Primary outcome
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
Time frame: pre-treatment, week 5, 6-month follow-up
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Time frame: pre-treatment, week 5, 6-month follow-up
Pressure pain threshold (PPT) is defined as the minimum amount of pressure that induces pain. PPT was assessed using a digital algometer. Measurements were taken over the upper border of the trapezius muscle, midway between the midline and the lateral border of the acromion, as well as in the suboccipital area, 2 cm lateral to the spinous process of the axis. The metal rod of the algometer was positioned vertically on each site, and the examiner applied gradually increasing pressure at a rate of 1 kg/s. PPT was recorded in kg/cm².
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Time frame: pre-treatment, week 5, 6-month follow-up
It is a self-reported, ten-item scale, with each item assessing different aspects of neck pain complaints. Most items relate to restrictions in activities of daily living, and each item is rated on a scale of 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score ranges from 0 to 50. The Neck Disability Index (NDI) is well-supported in the literature and is the most commonly used tool for reporting neck pain.
Changes in Cervical Range of Motion through goniometry
Time frame: pre-treatment, week 5, 6-month follow-up
Active cervical range of motion was measured using two types of goniometers: two bubble inclinometers and a large-scale universal goniometer. Measurements included active cervical flexion, extension, rotation, and side bending, with participants seated in an upright position. Range of motion was recorded in degrees.
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 8 Nov 2024.
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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, Ph.D study chair
Department of Physiotherapy, 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 Manual Therapy with TECAR and Manual Therapy without TECAR 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 1 inclusion and 1 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 8 Nov 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 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 Numeric Pain Rating Scale (NPRS) (time frame: pre-treatment, week 5, 6-month follow-up). 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 8 Nov 2024.