Neck PainNCT06953973
Investigation of the Effectiveness of Tecar Therapy in Patients With Chronic Neck Pain
A study testing Tecar Therapy and Standard Physiotherapy Program in people with Neck Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Study Design This study was planned as a randomized controlled, double-blind study. Chronic neck pain diagnosed by a specialist physician will be divided into 3 groups with a randomization model. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Tecar Therapy and Standard Physiotherapy Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-55,
- Having neck pain for 3 months or longer,
- Being able to come to the hospital for a standart physiotherapy program
Who cannot join
- Patients who have had a cervical spine injury or surgery
- Patients with neck pain secondary to a neurological or vascular disorder or neoplasia
- Patients with radiculopathy and neurological deficits
- Patients with a history of inflammatory or infective arthritis in the cervical spine
- Patients who have received a physical therapy program in the last 6 months
- Patients with open wounds or risk of infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University
Kırşehir, Center, 40100
Muhammed İhsan KODAK, PhD, 553 233 36 61 ext. +90, kodakihsan@gmail.com
About this study
Study Design This study was planned as a randomized controlled, double-blind study. Chronic neck pain diagnosed by a specialist physician will be divided into 3 groups with a randomization model. Interested individuals will be included in the study if they meet the inclusion criteria and sign the 'Informed Voluntary Consent Form' after the study is explained.
Patients will be divided into 3 groups with a randomization (secretary not in the study) model.
Read more
Patients who choose 1 will be applied Tecar Therapy + Standard Physiotherapy Program (SFP), those who choose 2 will be applied Sham Tecar Therapy +SFP and those who choose 3 will be applied SFP. The first and last evaluations of all 3 groups will be made by the same blind evaluator.
Randomization After the study is explained to the patients with chronic neck pain who meet the inclusion and exclusion criteria, those who volunteer will be asked to sign the "Informed Voluntary Consent Form". Those who volunteer to participate in the study will be randomly assigned to Group 1, Group 2 or 3. Participants will be randomly assigned to a card. Those who draw number 1 will be assigned to the SFP+Tecar Therapy group, those who draw number 2 will be assigned to the Sham Tecar Therapy + SFP group, and those who draw number 3 will be assigned to the SFP only group.
Visual Analog Scale (VAS) The pain intensity felt by the participants in the knee joint during rest and activity will be evaluated with VAS. VAS is an easy-to-use scale as it does not have any language and is frequently applied in clinics. Individuals will be asked to describe the pain they feel during the test on a 10 cm scale as "0" (no pain) and "10" (unbearable pain). A 34% decrease in VAS after TKA is considered clinically significant.
Neck Disability Index Neck Disability Index (NDI) was developed by Vernon et al. The Turkish version study was conducted by Aslan et al. The NDI includes a total of 10 questions such as pain, personal care, concentration, work, driving, and sleeping. Each question is scored between 0 and 5 points. A score of 0 means no restriction, and a score of 50 means full restriction. A score between 0-4 indicates no restriction, a score between 5-14 indicates mild restriction, a score between 14-24 indicates moderate restriction, a score between 25-34 indicates severe restriction, and a score above 35 indicates restriction.
Tampa Kinesiophobia Scale TKÖ is a 17-question checklist and is used in acute and chronic low back pain, fibromyalgia, musculoskeletal injuries, and whiplash-related diseases. The scale uses a 4-point Likert scale (1= I strongly disagree, 4= I strongly agree). A total score is calculated after reversing items 4, 8, 12, and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has high kinesiophobia. The validity and reliability of the questionnaire in Turkish was conducted by Tunca Yılmaz et al.
Quality of Life (SF-12) SF-12 consists of 8 sub-dimensions and 12 items, including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). While the items related to physical and emotional role are answered dichotomously (yes or no), other items have Likert-type options ranging from 3 to 6. The total score of the survey varies between 0-100, with higher scores representing better health. The validity and reliability of the survey in Turkish was performed by Soylu et al.
Hospital Anxiety Depression Scale The scale is used to determine the risk of anxiety and depression in patients, and to measure their levels and changes in severity. The scale consists of a total of 14 questions. Seven of these (odd numbers) measure anxiety, while the other seven (even numbers) measure depression. The scale provides a four-point Likert-type measurement. Each item is scored differently. Items 1, 3, 5, 6, 8, 10, 11 and 13 show decreasing severity and are scored in the form of 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12 and 14 are scored in the form of 0, 1, 2, 3. The total scores of the subscales are obtained by adding these item scores. While items 1, 3, 5, 7, 9, 11 and 13 are added for the anxiety subscale, the scores of items 2, 4, 6, 8, 10, 12 and 14 are added for the depression subscale. Each heading is scored between 0-21. High scores indicate high anxiety and depression. The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith in 1983. In our country, the validity and reliability study was conducted by Aydemir in 1997.
Global Rating Of Change Scale This scale is frequently used to evaluate patient satisfaction in orthopedic clinical studies. It is designed to determine the amount of improvement or deterioration of the patient over time. In GRC, which is a Likert-type scale, the options in the plus and minus value ranges and the labels assigned to these degrees
- Conditions
- Neck Pain
- Being tested
- Tecar Therapy, Sham Tecar Therapy, Standard Physiotherapy Program
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecar TherapyOther
Tecar Therapy will be applied by a specialist physiotherapist with WINTECARE T-PLUS-Switzerland. Participants in the experimental group included in the Tecar therapy application will be applied to the muscle groups in the neck region at a fixed frequency of 0.448 Mhz for 10 minutes.
Sham Tecar TherapyOther
Tecar Therapy will be applied by a specialist physiotherapist with WINTECARE T-PLUS-Switzerland. The patient will be positioned as in the Tecar group, but the heating feature of the device will not be activated.
Standard Physiotherapy ProgramOther
This study will include routinely applied conventional physiotherapy, heat modalities, electrotherapy (transcutaneous electrical nerve stimulation (TENS) and ultrasound therapy), and exercises. In this study, hot pack will be used to induce vasodilation and reduce muscle spasm. Hot pack will be used for 15 minutes to relax muscle spasms and increase soft tissue flexibility. TENS is a simple noninvasive modality and is widely used in both acute and chronic neck pain. In our study, 50 Hz conventional TENS with a pulse duration of <150 microseconds will be used. TENS will be applied to the painful area of the neck for 20 minutes. Ultrasound therapy used to warm deep tissues is one of the most frequently used physical therapy methods. An ultrasound device (Chattanooga, USA) will be used in the study. Ultrasound gel will be applied circularly with a thickness of 2-3 mm. Ultrasound will be applied with a 4 cm2 probe for 5 minutes with a frequency of 1 MHz and 1.5 Wt/cm2. Within the scope o
| Study group | Role | What they receive |
|---|---|---|
| Tecar Therapy + Standard Physiotherapy Program | Experimental | Not described Receives: Other: Tecar Therapy; Other: Standard Physiotherapy Program |
| Sham Tecar Therapy + Standard Physiotherapy Program | Sham comparator | Not described Receives: Other: Sham Tecar Therapy; Other: Standard Physiotherapy Program |
| Standard Physiotherapy Program | Active comparator | Not described Receives: Other: Standard Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Measured: 0-4 weeks
Neck Disability İndex
Measured: 0-4 weeks
Secondary outcomes (4)
Tampa Kinesiophobia Scale
Measured: 0-4 weeks
Short Form-12 (SF-12)
Measured: 0-4 weeks
Hospital Anxiety Depression Scale
Measured: 0-4 weeks
Global Rating Of Change Scale-GRC
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start2 Jun 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
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.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed İhsan KODAK, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953973
- Sponsor's protocol ID
- 2024/369
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 21 May 2025
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Tecar Therapy in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06953973
- Acronym / sponsor ID
- 2024/369
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 1 May 2025 (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.
Study Design This study was planned as a randomized controlled, double-blind study. Chronic neck pain diagnosed by a specialist physician will be divided into 3 groups with a randomization model. Interested individuals will be included in the study if they meet the inclusion criteria and sign the 'Informed Voluntary Consent Form' after the study is explained.
Patients will be divided into 3 groups with a randomization (secretary not in the study) model.
Patients who choose 1 will be applied Tecar Therapy + Standard Physiotherapy Program (SFP), those who choose 2 will be applied Sham Tecar Therapy +SFP and those who choose 3 will be applied SFP. The first and last evaluations of all 3 groups will be made by the same blind evaluator.
Randomization After the study is explained to the patients with chronic neck pain who meet the inclusion and exclusion criteria, those who volunteer will be asked to sign the "Informed Voluntary Consent Form". Those who volunteer to participate in the study will be randomly assigned to Group 1, Group 2 or 3. Participants will be randomly assigned to a card. Those who draw number 1 will be assigned to the SFP+Tecar Therapy group, those who draw number 2 will be assigned to the Sham Tecar Therapy + SFP group, and those who draw number 3 will be assigned to the SFP only group.
Visual Analog Scale (VAS) The pain intensity felt by the participants in the knee joint during rest and activity will be evaluated with VAS. VAS is an easy-to-use scale as it does not have any language and is frequently applied in clinics. Individuals will be asked to describe the pain they feel during the test on a 10 cm scale as "0" (no pain) and "10" (unbearable pain). A 34% decrease in VAS after TKA is considered clinically significant.
Neck Disability Index Neck Disability Index (NDI) was developed by Vernon et al. The Turkish version study was conducted by Aslan et al. The NDI includes a total of 10 questions such as pain, personal care, concentration, work, driving, and sleeping. Each question is scored between 0 and 5 points. A score of 0 means no restriction, and a score of 50 means full restriction. A score between 0-4 indicates no restriction, a score between 5-14 indicates mild restriction, a score between 14-24 indicates moderate restriction, a score between 25-34 indicates severe restriction, and a score above 35 indicates restriction.
Tampa Kinesiophobia Scale TKÖ is a 17-question checklist and is used in acute and chronic low back pain, fibromyalgia, musculoskeletal injuries, and whiplash-related diseases. The scale uses a 4-point Likert scale (1= I strongly disagree, 4= I strongly agree). A total score is calculated after reversing items 4, 8, 12, and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has high kinesiophobia. The validity and reliability of the questionnaire in Turkish was conducted by Tunca Yılmaz et al.
Quality of Life (SF-12) SF-12 consists of 8 sub-dimensions and 12 items, including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). While the items related to physical and emotional role are answered dichotomously (yes or no), other items have Likert-type options ranging from 3 to 6. The total score of the survey varies between 0-100, with higher scores representing better health. The validity and reliability of the survey in Turkish was performed by Soylu et al.
Hospital Anxiety Depression Scale The scale is used to determine the risk of anxiety and depression in patients, and to measure their levels and changes in severity. The scale consists of a total of 14 questions. Seven of these (odd numbers) measure anxiety, while the other seven (even numbers) measure depression. The scale provides a four-point Likert-type measurement. Each item is scored differently. Items 1, 3, 5, 6, 8, 10, 11 and 13 show decreasing severity and are scored in the form of 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12 and 14 are scored in the form of 0, 1, 2, 3. The total scores of the subscales are obtained by adding these item scores. While items 1, 3, 5, 7, 9, 11 and 13 are added for the anxiety subscale, the scores of items 2, 4, 6, 8, 10, 12 and 14 are added for the depression subscale. Each heading is scored between 0-21. High scores indicate high anxiety and depression. The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith in 1983. In our country, the validity and reliability study was conducted by Aydemir in 1997.
Global Rating Of Change Scale This scale is frequently used to evaluate patient satisfaction in orthopedic clinical studies. It is designed to determine the amount of improvement or deterioration of the patient over time. In GRC, which is a Likert-type scale, the options in the plus and minus value ranges and the labels assigned to these degrees
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tecar Therapy + Standard Physiotherapy Program | Experimental | Other: Tecar Therapy, Other: Standard Physiotherapy Program |
| Sham Tecar Therapy + Standard Physiotherapy Program | Sham comparator | Other: Sham Tecar Therapy, Other: Standard Physiotherapy Program |
| Standard Physiotherapy Program | Active comparator | Other: Standard Physiotherapy Program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-55,
- Having neck pain for 3 months or longer,
- Being able to come to the hospital for a standart physiotherapy program
Key exclusion criteria (6 listed)
- Patients who have had a cervical spine injury or surgery
- Patients with neck pain secondary to a neurological or vascular disorder or neoplasia
- Patients with radiculopathy and neurological deficits
- Patients with a history of inflammatory or infective arthritis in the cervical spine
- Patients who have received a physical therapy program in the last 6 months
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 |
|---|---|---|
| Tecar TherapyTecar Therapy will be applied by a specialist physiotherapist with WINTECARE T-PLUS-Switzerland. Participants in the experimental group included in the Tecar therapy application will be applied to the muscle groups in the neck region at a fixed frequency of 0.448 Mhz for 10 minutes. | Other | Tecar Therapy + Standard Physiotherapy Program |
| Sham Tecar TherapyTecar Therapy will be applied by a specialist physiotherapist with WINTECARE T-PLUS-Switzerland. The patient will be positioned as in the Tecar group, but the heating feature of the device will not be activated. | Other | Sham Tecar Therapy + Standard Physiotherapy Program |
| Standard Physiotherapy ProgramThis study will include routinely applied conventional physiotherapy, heat modalities, electrotherapy (transcutaneous electrical nerve stimulation (TENS) and ultrasound therapy), and exercises. In this study, hot pack will be used to induce vasodilation and reduce muscle spasm. Hot pack will be used for 15 minutes to relax muscle spasms and increase soft tissue flexibility. TENS is a simple noninvasive modality and is widely used in both acute and chronic neck pain. In our study, 50 Hz conventional TENS with a pulse duration of <150 microseconds will be used. TENS will be applied to the painful area of the neck for 20 minutes. Ultrasound therapy used to warm deep tissues is one of the most frequently used physical therapy methods. An ultrasound device (Chattanooga, USA) will be used in the study. Ultrasound gel will be applied circularly with a thickness of 2-3 mm. Ultrasound will be applied with a 4 cm2 probe for 5 minutes with a frequency of 1 MHz and 1.5 Wt/cm2. Within the scope o | Other | Sham Tecar Therapy + Standard Physiotherapy Program, Standard Physiotherapy Program, Tecar Therapy + Standard Physiotherapy Program |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 0-4 weeks
Neck Disability İndex
Time frame: 0-4 weeks
4 secondary outcomes
Tampa Kinesiophobia Scale
Time frame: 0-4 weeks
Short Form-12 (SF-12)
Time frame: 0-4 weeks
Hospital Anxiety Depression Scale
Time frame: 0-4 weeks
Global Rating Of Change Scale-GRC
Time frame: 0-4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecar Therapy and Standard Physiotherapy Program in people with Neck Pain, run by Kirsehir Ahi Evran Universitesi 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed İhsan KODAK, PhD (553 233 36 61 ext. +90, kodakihsan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 0-4 weeks). 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?
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 21 May 2025.