NCT07780747

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 15, 2026

Last Update Submit

August 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short-Form McGill Pain Questionnaire (SF-MPQ):

    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)

    Baseline, 3th weeks

Secondary Outcomes (3)

  • Beck Depression Inventory (BDI):

    Baseline, 3th weeks

  • Copenhagen Neck Functional Disability Index (CNFDI): Copenhagen Neck Functional Disability Index (CNFDI):

    Baseline, 3th weeks

  • Short Form-36 (SF-36)

    Baseline, 3th weeks

Study Arms (3)

patients who received TENS for chronic neck pain

EXPERIMENTAL

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.

Device: TENS

patients who received IFC for chronic neck pain

EXPERIMENTAL

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.

Device: IFC

Control

SHAM COMPARATOR

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.

Other: Sham electrotherapy

Interventions

TENSDEVICE

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.

patients who received TENS for chronic neck pain
IFCDEVICE

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.

patients who received IFC for chronic neck pain

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.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 21, 2026

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 21, 2026

Record last verified: 2026-08