Chronic Neck PainNCT06562933
Comparison of Efficiency of Interferential Current Application Methods in Chronic Neck Pain
A study testing Interferential Current Therapy Vacuum Electrodes and Interferential Current Therapy Carbon-silicon Pad Electrodes in people with Chronic Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Interferential Current Therapy Vacuum Electrodes and Interferential Current Therapy Carbon-silicon Pad Electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Apr 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic neck pain lasting at least 3 months
- Ages between 20 and 50 years
Who cannot join
- Patients with inflammatory or infectious diseases and those with radiculopathy or myelopathy symptoms
- Patients for whom electrotherapy is contraindicated (e.g., those with pregnancy, neurological conditions such as epilepsy, inner ear hearing aids, arrhythmias, pacemakers, active infections, skin lesions, etc.)
- Individuals with a history of malignancy, major surgery, or previous trauma
- Individuals who have received physical therapy within the last year
- Patients whose evaluation could not be completed for any reason
- Patients who do not wish to complete their evaluations for any reason
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, 1 recruiting
- Recruiting
Abant Izzet Baysal University
Bolu, 14100
Serdar Kılınç, 905055913181, drserdarkilinc@hotmail.com
Mustafa Fatih Yaşar
About this study
The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes.
Read the detailed description
Neck pain is quite common in the adult population and is a frequent reason for seeking medical attention. The prevalence of neck problems has increased with modern lifestyle changes. In individuals with neck pain, symptoms may resolve on their own within a few weeks, but approximately 30% of cases can become chronic. Neck pain lasting 1-4 weeks is considered acute; 4-12 weeks is subacute; and neck pain persisting for 12 weeks or more is considered chronic. Interferential current therapy is used in the treatment of chronic neck pain and is one of the physical therapy methods with analgesic effects. It is widely used around the world. Interferential Current Therapy can be applied using two types of electrodes: vacuum electrodes and carbon-silicon pad electrodes.The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes
- Conditions
- Chronic Neck Pain
- Being tested
- Sham vacuum, Interferential Current Therapy Vacuum Electrodes, Interferential Current Therapy Carbon-silicon Pad Electrodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham vacuumDevice
Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. The vacuum electrodes will apply continuous vacuum mode for only 10 minutes without delivering interferential current. Following the sham vacuum therapy, a hot pack will be applied to the painful neck area for 20 minutes.
Interferential Current Therapy Vacuum ElectrodesDevice
Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the vacuum electrodes. After the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes.
Interferential Current Therapy Carbon-silicon Pad ElectrodesDevice
Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four carbon-silicon pad electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the carbon-silicon pad electrodes. Following the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sham vacuum | Sham comparator | Sham vacuum Receives: Device: Sham vacuum |
| Interferential Current Therapy Vacuum Electrodes | Active comparator | Interferential Current Therapy Vacuum Electrodes Receives: Device: Interferential Current Therapy Vacuum Electrodes |
| Interferential Current Therapy Carbon-silicon Pad Electrodes | Active comparator | Interferential Current Therapy Carbon-silicon Pad Electrodes Receives: Device: Interferential Current Therapy Carbon-silicon Pad Electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Pain Rating Scale
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Measured: Before treatment
The Numerical Pain Rating Scale
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Measured: 2 week after treatment
Pressure Pain Threshold
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Measured: Before treatment
Pressure Pain Threshold
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Measured: 2 week after treatment
Neck Bournemouth Questionnaire
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Measured: Before treatment
Neck Bournemouth Questionnaire
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Measured: 2 week after treatment
Neck Disability Index
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Measured: Before treatment
Neck Disability Index
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Measured: 2 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562933
- Sponsor's protocol ID
- AIBU-FTR-SK-8
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2024
- Last updated
- 26 Feb 2025
- Results posted
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficiency of Interferential Current Application Methods in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06562933
- Acronym / sponsor ID
- AIBU-FTR-SK-8
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes.
Detailed description
Neck pain is quite common in the adult population and is a frequent reason for seeking medical attention. The prevalence of neck problems has increased with modern lifestyle changes. In individuals with neck pain, symptoms may resolve on their own within a few weeks, but approximately 30% of cases can become chronic. Neck pain lasting 1-4 weeks is considered acute; 4-12 weeks is subacute; and neck pain persisting for 12 weeks or more is considered chronic. Interferential current therapy is used in the treatment of chronic neck pain and is one of the physical therapy methods with analgesic effects. It is widely used around the world. Interferential Current Therapy can be applied using two types of electrodes: vacuum electrodes and carbon-silicon pad electrodes.The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham vacuum | Sham comparator | Device: Sham vacuumSham vacuum |
| Interferential Current Therapy Vacuum Electrodes | Active comparator | Device: Interferential Current Therapy Vacuum ElectrodesInterferential Current Therapy Vacuum Electrodes |
| Interferential Current Therapy Carbon-silicon Pad Electrodes | Active comparator | Device: Interferential Current Therapy Carbon-silicon Pad ElectrodesInterferential Current Therapy Carbon-silicon Pad Electrodes |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with chronic neck pain lasting at least 3 months
- Ages between 20 and 50 years
Key exclusion criteria (6 listed)
- Patients with inflammatory or infectious diseases and those with radiculopathy or myelopathy symptoms
- Patients for whom electrotherapy is contraindicated (e.g., those with pregnancy, neurological conditions such as epilepsy, inner ear hearing aids, arrhythmias, pacemakers, active infections, skin lesions, etc.)
- Individuals with a history of malignancy, major surgery, or previous trauma
- Individuals who have received physical therapy within the last year
- Patients whose evaluation could not be completed for any reason
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 |
|---|---|---|
| Sham vacuumParticipants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. The vacuum electrodes will apply continuous vacuum mode for only 10 minutes without delivering interferential current. Following the sham vacuum therapy, a hot pack will be applied to the painful neck area for 20 minutes. | Device | Sham vacuum |
| Interferential Current Therapy Vacuum ElectrodesParticipants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the vacuum electrodes. After the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes. | Device | Interferential Current Therapy Vacuum Electrodes |
| Interferential Current Therapy Carbon-silicon Pad ElectrodesParticipants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four carbon-silicon pad electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the carbon-silicon pad electrodes. Following the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes. | Device | Interferential Current Therapy Carbon-silicon Pad Electrodes |
Primary outcome
The Numerical Pain Rating Scale
Time frame: Before treatment
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
The Numerical Pain Rating Scale
Time frame: 2 week after treatment
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Pressure Pain Threshold
Time frame: Before treatment
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Pressure Pain Threshold
Time frame: 2 week after treatment
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Neck Bournemouth Questionnaire
Time frame: Before treatment
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Neck Bournemouth Questionnaire
Time frame: 2 week after treatment
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Neck Disability Index
Time frame: Before treatment
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Neck Disability Index
Time frame: 2 week after treatment
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
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 26 Feb 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 Interferential Current Therapy Vacuum Electrodes and Interferential Current Therapy Carbon-silicon Pad Electrodes in people with Chronic Neck Pain, run by Abant Izzet Baysal 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 2 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: looking for participants now, as of the sponsor's last update on 26 Feb 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 Serdar Kılınç (905055913181, drserdarkilinc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Pain Rating Scale (time frame: Before treatment). The study lists 8 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 26 Feb 2025.