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Completed

NCT Number: NCT07780747

Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Chronic Neck Pain

The aim of this study was to determine and compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential current (IFC), and sham therapy in patients with chronic neck pain.

A total of 57 patients diagnosed with chronic mechanical neck pain were included in the study. Patients were randomized into three groups. Each group received 10 sessions of physiotherapy over a two-week period: one group received conventional TENS, one group received IFC, and one group received sham therapy. Pain was assessed using the Visual Analog Scale (VAS), disability and functionality using the Copenhagen Neck Disability Index, quality of life using the SF-36, depression using the Beck Depression Inventory (BDI), and pain characteristics using the SF-McGill Pain Questionnaire.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria:

  • having neck pain for more than six months,
  • being between 18 and 60 years of age,
  • having sufficient cognitive capacity to complete the study questionnaires,
  • being functionally able to participate in an outpatient physical therapy program
  • voluntarily agreeing to participate in the study.

The exclusion criteria:

  • the presence of motor deficits due to neurological involvement;
  • neurological conditions causing dizziness or balance loss;
  • congenital pathology of the cervical spine;
  • uncontrolled diabetes mellitus or hypertension; any contraindication to electrotherapy (such as pregnancy, severe arrhythmia, pacemaker, active infection, or skin lesions);
  • having received physical therapy or injection treatment for the neck region within the past year;
  • the presence of any connective tissue or rheumatologic disease (such as seronegative spondyloarthropathies or rheumatoid arthritis);
  • the presence of a mass lesion in the cervical spine or neck region;
  • a history of cervical spine fracture; and
  • the presence of psychiatric or cognitive disorders.

Treatment and study plan

TENS

Device

Transcutaneous electrical nerve stimulation (TENS) was applied to the cervical region using four electrodes. Treatment was administered using a FİZYOMED FİZYOTENS-4000 device in conventional mode with a stimulation frequency of 40 Hz and a pulse duration of 100 μs. Each session lasted 20 minutes. Treatment was administered for 10 sessions over 2 weeks. Participants also received a home exercise program and education on protective techniques.

IFC

Device

Interferential current (IFC) therapy was applied to the cervical region using four electrodes and an ET 3000 combined electrotherapy device. Treatment was administered with a carrier frequency of 4000 Hz, a stimulation frequency of 40 Hz, and an amplitude-modulated frequency (AMF) of 40 Hz using a 1/1 rectangular spectrum. Each session lasted 20 minutes. Treatment was administered for 10 sessions over 2 weeks. Participants also received a home exercise program and education on protective techniques.

Sham electrotherapy

Other

Sham electrotherapy was applied to the cervical region using four electrodes. The electrotherapy device was turned on, but no electrical current was delivered. Each sham treatment session lasted 20 minutes. Treatment was administered for 10 sessions over 2 weeks. Participants also received a home exercise program and education on protective techniques.

Primary outcomes

  1. Short-Form McGill Pain Questionnaire (SF-MPQ):

    Time frame: Baseline, 3th weeks

    The SF-MPQ, developed by Melzack in 1987 and validated in Turkish by Yakut et al., is widely used to assess pain. It evaluates sensory, affective, and total pain dimensions, along with VAS and Present Pain Intensity (PPI). The questionnaire consists of 15 descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), yielding sensory, affective, and total pain scores. PPI is assessed using a 6-point Likert scale ranging from 0 (no pain) to 5 (unbearable pain)

Secondary outcomes

  1. Beck Depression Inventory (BDI):

    Time frame: Baseline, 3th weeks

    The BDI was developed by Beck et al., and its Turkish validity and reliability have been established. The total score ranges from 0 to 63, with 0-21 indicating mild, 21-42 moderate, and 42-63 severe depression.

  2. Copenhagen Neck Functional Disability Index (CNFDI): Copenhagen Neck Functional Disability Index (CNFDI):

    Time frame: Baseline, 3th weeks

    The CNFDI was developed by Jordan et al. in 1998, and its Turkish version was validated by Yapalı et al. It consists of 15 items assessing pain intensity and its impact on daily activities, social interaction, and functional disability. Total scores range from 0 to 30.

  3. Short Form-36 (SF-36)

    Time frame: Baseline, 3th weeks

    The Turkish version of SF-36 was validated by Koçyiğit et al. It consists of 36 items and 8 subscales assessing physical and mental health: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Comparison of the Therapeutic Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Patients With Chronic Neck Pain: A Prospective, Randomized, Double-Blind Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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