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Elektrisk stimulering hos individer med kronisk nakkesmerter

21. oktober 2026 oppdatert av: Gülşen Taşkın, Afyonkarahisar Health Sciences University

Undersøkelse av effekten av diadynamisk strøm og transkutan elektrisk nervestimulering på smerte og funksjonalitet hos individer med kronisk nakkesmerter

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

96

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Afyonkarahisar
      • Afyonkarahisar, Afyonkarahisar, Tyrkia (Türkiye), 03030
        • Afyonkarahisar Health Science University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

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.

Eksperimentell: 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.

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.

Eksperimentell: Control Group

The participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain

The participants in all groups will be given exercises to strengthen the muscles around the neck for 10 repetitions 2 times a day. These exercises are the routine exercises given to patients who apply to Başkent University Department of Physical Medicine and Rehabilitation with neck pain

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of pain intensity change in participants with chronic neck pain.
Tidsramme: 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.

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of functionality in participants with chronic neck pain.
Tidsramme: 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.

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall pain
Tidsramme: 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.

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Gülşen Taşkın, Assist. Prof., Afyonkarahisar Health Sciences University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. mars 2025

Primær fullføring (Faktiske)

22. august 2026

Studiet fullført (Faktiske)

22. august 2026

Datoer for studieregistrering

Først innsendt

12. mars 2025

Først innsendt som oppfylte QC-kriteriene

3. april 2025

Først lagt ut (Faktiske)

4. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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