Electrical Stimulation in Individuals With Chronic Neck Pain

NCT06911125 | Active Not Recruiting

• 1 other identifier: KA23/207
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transcutaneous Electric Nerve Stimulation; Diadynamic Current; Neck pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of functionality in participants with chronic neck pain.

  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 Outcomes (1)

• Overall pain

  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

Study Arms (2)

TENS

EXPERIMENTAL

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

Diadynamic Currents

EXPERIMENTAL

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

Interventions

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.

TENS

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.

Diadynamic Currents

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Türkiye, Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Gülşen Taşkın, Assist. Prof.

  Afyonkarahisar Health Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 4, 2025
• Study Start: March 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)