Electrical Stimulation in Individuals With Chronic Neck Pain

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Neck Pain; Functional Status; Pain Intensity Assessment; Neck Pain Chronic
• Intervention / Treatment: Device: TENS; Device: Diadinamic Current

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 Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Afyonkarahisar
    • Türkiye, Afyonkarahisar, Turkey, 03030
      • Afyonkarahisar Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pain	McGill Pain Questionnaire- Short Form will be used to assess the overall pain of participants. McGill Pain Questionnaire- Short Form The McGill Pain Questionnaire Short Form is sufficiently sensitive to determine the efficacy of treatment interventions in alleviating pain. The questionnaire comprises 15 characteristics evaluated on a 4-point scale (the initial 11 evaluate the kind of pain, while the final 4 measure the emotional dimension): 0 = none, 1 = mild, 2 = moderate, 3 = severe.	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

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Study Director: Gülşen Taşkın, Assist. Prof., Afyonkarahisar Health Science University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Transcutaneous Electric Nerve Stimulation; Diadynamic Current; Neck pain Chronic
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Neck Pain
• Other Study ID Numbers: KA23/207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No