PainNCT06911125
Electrical Stimulation in Individuals With Chronic Neck Pain
A study testing TENS and Diadinamic Current in people with Pain and Neck Pain, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Neck Pain, Neck Pain Chronic
- What is being tested?
- TENS and Diadinamic Current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2025to 22 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be aged 18 to 60. Participants must report chronic neck pain for a minimum duration of three months.
- Participants experiencing pain must have a Visual Analog Scale (VAS) score of at least 3.
Who cannot join
- Participants with a history of neck or shoulder surgery Participants diagnosed with a rheumatic or neurological disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, Afyonkarahisar, 03030
About this study
Official title: Investigation of the Effects of Diadynamic Current and Transcutaneous Electrical Nerve Stimulation on Pain and Functionality in Individuals With Chronic Neck Pain
The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.
Read the detailed description
Chronic neck pain is a common problem in individuals of all ages. Approximately two-thirds of individuals experience neck pain at least once in their lifetime. The methods used to treat non-specific neck pain are conservative-oriented, with medical treatment and physiotherapy being the first-line modalities. Electrotherapy tools like transcutaneous electrical stimulation (TENS), interferential current, diadynamic current, laser, and ultrasound are used to treat chronic neck pain. So are thermal modalities like hot packs, cold packs, hydrotherapy, and infrared; exercise therapies like neuromuscular control, diversified therapeutic exercises, range of motion (ROM) exercises, and strengthening exercises; and interventions like massage, mobilization-manipulation, and traction.
Methods that reduce pain and improve function are essential in treatment. Electrotherapy is a commonly used treatment among physical therapy modalities. While the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.
The study's hypotheses are as follows:
Hypothesis 1: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain in participants with chronic neck pain.
Hypothesis 2: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on functionality in participants with chronic neck pain.
- Conditions
- Pain, Neck Pain, Neck Pain Chronic, Pain Intensity Assessment, Functional Status
- Being tested
- TENS, Diadinamic Current, Control grup
- Keywords
- Transcutaneous Electric Nerve Stimulation, Diadynamic Current, Neck pain Chronic
- Medical subject headings
- Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS will be applied paravertebrally using four electrodes in the neck and back areas. Self-adhesive electrodes specific to each participant will be used for the application. TENS will run on symmetrical biphasic current at 100 Hz and 120 microseconds. The current intensity is determined by the level at which the person perceives the current. The participants are informed that they will get a current, which may induce a pins-and-needles sensation. It is essential for them to perceive the current distinctly; the intensity should be sufficient to be sensed without causing discomfort. The duration of the treatment is 20 minutes. Participants will receive exercises to strengthen the muscles around the neck.
All participants will receive treatment once a day, five days a week. A total of 15 sessions will be conducted over a duration of 3 weeks.
Diadinamic CurrentDevice
Diadynamic current will be performed paravertebrally using two electrodes on the neck and back areas. Participant-specific self-adhesive electrodes will be utilized for the application. In diadynamic current, two distinct current modules, namely diphase-fixed (2 minutes) and short period (8 minutes), will be utilized. The cumulative duration of the treatment is 10 minutes. The program will provide the current intensity at the threshold perceived by the individual. The participants will be informed about the application as follows: 'You will receive a current; you may have a pins-and-needles sensation; it is crucial to perceive the current distinctly and thoroughly; the intensity should neither be insufficient to be felt nor excessive to cause discomfort.' Participants will receive exercises to strengthen the muscles around the neck.All participants will receive treatment once a day, five days a week. A total of 15 sessions will be conducted over a duration of 3 weeks.
Control grupOther
The participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | While the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. Receives: Device: TENS |
| Diadynamic Currents | Experimental | While the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. Receives: Device: Diadinamic Current |
| Control Group | Experimental | The participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain Receives: Other: Control grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain intensity change in participants with chronic neck pain.
Visual Analog Scale will be used to assess pain intensity.
Visual Analog Scale Participants will be instructed to indicate their average pain intensity during rest, activity, and sleep on a 10-centimeter (cm) line, where 0 represents no pain and 10 represents horrible pain. The distance from the origin to the participant-marked point will be measured using a ruler, and pre-treatment pain scores will be recorded.
Measured: The first evaluation will be done before the treatment, the treatment program will be applied for 3 weeks and the same evaluations will be done again after the treatment is over
Secondary outcomes (1)
Evaluation of functionality in participants with chronic neck pain.
The Neck Disability Index is a scale that shows the functional status of the participants. The Neck Disability Index consists of ten questions related to pain intensity, personal care, lifting, reading, concentration, headaches, working, driving, sleeping, and recreational activities. For each question, there are 6 options ranging from 0 to 5 points. The questionnaire is evaluated out of a maximum of 50 points. "0 points" means no restrictions; "50 points' means full disability. "0-4 points" means no restriction, "5-14 points' means slightly restricted, "14-24 points' means moderately restricted, "25-34 points' means severely restricted, and "35 and above' means completely restricted.
Measured: The first evaluation will be done before the treatment, the treatment program will be applied for 3 weeks and the same evaluations will be done again after the treatment is over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start12 Mar 2025
- Primary completion22 Aug 2026
- Study completion22 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşen Taşkın, Afyonkarahisar Health Sciences University
- Investigators
- Gülşen Taşkın, Assist. Prof., Study director, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911125
- Sponsor's protocol ID
- KA23/207
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2025
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Diadynamic Current and Transcutaneous Electrical Nerve Stimulation on Pain and Functionality in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06911125
- Acronym / sponsor ID
- KA23/207
- Conditions
- Pain, Neck Pain, Neck Pain Chronic, Pain Intensity Assessment, Functional Status
- Keywords
- Transcutaneous Electric Nerve Stimulation, Diadynamic Current, Neck pain Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 22 Aug 2026 (actual)
- Study completion
- 22 Aug 2026 (actual)
- First posted
- 4 Apr 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.
The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.
Detailed description
Chronic neck pain is a common problem in individuals of all ages. Approximately two-thirds of individuals experience neck pain at least once in their lifetime. The methods used to treat non-specific neck pain are conservative-oriented, with medical treatment and physiotherapy being the first-line modalities. Electrotherapy tools like transcutaneous electrical stimulation (TENS), interferential current, diadynamic current, laser, and ultrasound are used to treat chronic neck pain. So are thermal modalities like hot packs, cold packs, hydrotherapy, and infrared; exercise therapies like neuromuscular control, diversified therapeutic exercises, range of motion (ROM) exercises, and strengthening exercises; and interventions like massage, mobilization-manipulation, and traction.
Methods that reduce pain and improve function are essential in treatment. Electrotherapy is a commonly used treatment among physical therapy modalities. While the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.
The study's hypotheses are as follows:
Hypothesis 1: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain in participants with chronic neck pain.
Hypothesis 2: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on functionality in participants with chronic neck pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: TENSWhile the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. |
| Diadynamic Currents | Experimental | Device: Diadinamic CurrentWhile the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. |
| Control Group | Experimental | Other: Control grupThe participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be aged 18 to 60. Participants must report chronic neck pain for a minimum duration of three months.
- Participants experiencing pain must have a Visual Analog Scale (VAS) score of at least 3.
Key exclusion criteria (1 listed)
- Participants with a history of neck or shoulder surgery Participants diagnosed with a rheumatic or neurological disorder
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 |
|---|---|---|
| TENSTENS will be applied paravertebrally using four electrodes in the neck and back areas. Self-adhesive electrodes specific to each participant will be used for the application. TENS will run on symmetrical biphasic current at 100 Hz and 120 microseconds. The current intensity is determined by the level at which the person perceives the current. The participants are informed that they will get a current, which may induce a pins-and-needles sensation. It is essential for them to perceive the current distinctly; the intensity should be sufficient to be sensed without causing discomfort. The duration of the treatment is 20 minutes. Participants will receive exercises to strengthen the muscles around the neck. All participants will receive treatment once a day, five days a week. A total of 15 sessions will be conducted over a duration of 3 weeks. | Device | TENS |
| Diadinamic CurrentDiadynamic current will be performed paravertebrally using two electrodes on the neck and back areas. Participant-specific self-adhesive electrodes will be utilized for the application. In diadynamic current, two distinct current modules, namely diphase-fixed (2 minutes) and short period (8 minutes), will be utilized. The cumulative duration of the treatment is 10 minutes. The program will provide the current intensity at the threshold perceived by the individual. The participants will be informed about the application as follows: 'You will receive a current; you may have a pins-and-needles sensation; it is crucial to perceive the current distinctly and thoroughly; the intensity should neither be insufficient to be felt nor excessive to cause discomfort.' Participants will receive exercises to strengthen the muscles around the neck.All participants will receive treatment once a day, five days a week. A total of 15 sessions will be conducted over a duration of 3 weeks. | Device | Diadynamic Currents |
| Control grupThe participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain | Other | Control Group |
Primary outcome
Evaluation of pain intensity change in participants with chronic neck pain.
Time frame: The first evaluation will be done before the treatment, the treatment program will be applied for 3 weeks and the same evaluations will be done again after the treatment is over
Visual Analog Scale will be used to assess pain intensity. Visual Analog Scale Participants will be instructed to indicate their average pain intensity during rest, activity, and sleep on a 10-centimeter (cm) line, where 0 represents no pain and 10 represents horrible pain. The distance from the origin to the participant-marked point will be measured using a ruler, and pre-treatment pain scores will be recorded.
1 secondary outcome
Evaluation of functionality in participants with chronic neck pain.
Time frame: The first evaluation will be done before the treatment, the treatment program will be applied for 3 weeks and the same evaluations will be done again after the treatment is over
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 26 Oct 2026.
- 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.
Gülşen Taşkın, Assist. Prof. study director
Afyonkarahisar Health Sciences 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 TENS and Diadinamic Current in people with Pain and Neck Pain, run by Afyonkarahisar Health Sciences 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 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain intensity change in participants with chronic neck pain. (time frame: The first evaluation will be done before the treatment, the treatment program will be applied for 3 weeks and the same evaluations will be done again after the treatment is over). 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 Oct 2026.