Electrical Stimulation in Individuals With Chronic Neck Pain

NCT ID: NCT06911125

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-12-01

Brief 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. 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.

Conditions

Pain; Neck Pain; Neck Pain Chronic; Pain Intensity Assessment; Functional Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

TENS

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

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.

Diadynamic Currents

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.

Group Type: EXPERIMENTAL

Diadinamic Current

Intervention Type: DEVICE

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.

Interventions

TENS

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.

Intervention Type: DEVICE

Diadinamic Current

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Participants with a history of neck or shoulder surgery Participants diagnosed with a rheumatic or neurological disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Gülşen Taşkın

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülşen Taşkın, Assist. Prof.

Role: STUDY_DIRECTOR

Afyonkarahisar Health Science University

Locations

Afyonkarahisar Health Science University

Türkiye, Afyonkarahisar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA23/207

Identifier Type: -

Identifier Source: org_study_id