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NCT Number: NCT06911125

Electrical Stimulation 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.

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Key information

Conditions

Pain Functional Status Neck Pain Neck Pain Chronic Neurologic Manifestations Pain Intensity Assessment Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Science University

Türkiye, Afyonkarahisar, 03030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TENS

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.

Diadinamic Current

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. Overall 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

    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.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Investigation of the Effects of Diadynamic Current and Transcutaneous Electrical Nerve Stimulation on Pain and Functionality in Individuals With Chronic Neck Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

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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