- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07780747
Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Chronic Neck Pain
Comparison of the Therapeutic Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Patients With Chronic Neck Pain: A Prospective, Randomized, Double-Blind Study
The aim of this study was to determine and compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential current (IFC), and sham therapy in patients with chronic neck pain.
A total of 57 patients diagnosed with chronic mechanical neck pain were included in the study. Patients were randomized into three groups. Each group received 10 sessions of physiotherapy over a two-week period: one group received conventional TENS, one group received IFC, and one group received sham therapy. Pain was assessed using the Visual Analog Scale (VAS), disability and functionality using the Copenhagen Neck Disability Index, quality of life using the SF-36, depression using the Beck Depression Inventory (BDI), and pain characteristics using the SF-McGill Pain Questionnaire.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
The inclusion criteria:
- having neck pain for more than six months,
- being between 18 and 60 years of age,
- having sufficient cognitive capacity to complete the study questionnaires,
- being functionally able to participate in an outpatient physical therapy program
- voluntarily agreeing to participate in the study.
The exclusion criteria:
- the presence of motor deficits due to neurological involvement;
- neurological conditions causing dizziness or balance loss;
- congenital pathology of the cervical spine;
- uncontrolled diabetes mellitus or hypertension; any contraindication to electrotherapy (such as pregnancy, severe arrhythmia, pacemaker, active infection, or skin lesions);
- having received physical therapy or injection treatment for the neck region within the past year;
- the presence of any connective tissue or rheumatologic disease (such as seronegative spondyloarthropathies or rheumatoid arthritis);
- the presence of a mass lesion in the cervical spine or neck region;
- a history of cervical spine fracture; and
- the presence of psychiatric or cognitive disorders.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: patients who received TENS for chronic neck pain
Transcutaneous electrical nerve stimulation (TENS) was applied to the cervical region using four electrodes.
Treatment was administered using a FİZYOMED FİZYOTENS-4000 device in conventional mode with a stimulation frequency of 40 Hz and a pulse duration of 100 μs.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Transcutaneous electrical nerve stimulation (TENS) was applied to the cervical region using four electrodes.
Treatment was administered using a FİZYOMED FİZYOTENS-4000 device in conventional mode with a stimulation frequency of 40 Hz and a pulse duration of 100 μs.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
|
Experimentální: patients who received IFC for chronic neck pain
Interferential current (IFC) therapy was applied to the cervical region using four electrodes and an ET 3000 combined electrotherapy device.
Treatment was administered with a carrier frequency of 4000 Hz, a stimulation frequency of 40 Hz, and an amplitude-modulated frequency (AMF) of 40 Hz using a 1/1 rectangular spectrum.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Interferential current (IFC) therapy was applied to the cervical region using four electrodes and an ET 3000 combined electrotherapy device.
Treatment was administered with a carrier frequency of 4000 Hz, a stimulation frequency of 40 Hz, and an amplitude-modulated frequency (AMF) of 40 Hz using a 1/1 rectangular spectrum.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
|
Falešný srovnávač: Control
Sham electrotherapy was applied to the cervical region using four electrodes.
The electrotherapy device was turned on, but no electrical current was delivered.
Each sham treatment session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Sham electrotherapy was applied to the cervical region using four electrodes.
The electrotherapy device was turned on, but no electrical current was delivered.
Each sham treatment session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ):
Časové okno: Baseline, 3th weeks
|
The SF-MPQ, developed by Melzack in 1987 and validated in Turkish by Yakut et al., is widely used to assess pain.
It evaluates sensory, affective, and total pain dimensions, along with VAS and Present Pain Intensity (PPI).
The questionnaire consists of 15 descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), yielding sensory, affective, and total pain scores.
PPI is assessed using a 6-point Likert scale ranging from 0 (no pain) to 5 (unbearable pain)
|
Baseline, 3th weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Beck Depression Inventory (BDI):
Časové okno: Baseline, 3th weeks
|
The BDI was developed by Beck et al., and its Turkish validity and reliability have been established.
The total score ranges from 0 to 63, with 0-21 indicating mild, 21-42 moderate, and 42-63 severe depression.
|
Baseline, 3th weeks
|
|
Copenhagen Neck Functional Disability Index (CNFDI): Copenhagen Neck Functional Disability Index (CNFDI):
Časové okno: Baseline, 3th weeks
|
The CNFDI was developed by Jordan et al. in 1998, and its Turkish version was validated by Yapalı et al.
It consists of 15 items assessing pain intensity and its impact on daily activities, social interaction, and functional disability.
Total scores range from 0 to 30.
|
Baseline, 3th weeks
|
|
Short Form-36 (SF-36)
Časové okno: Baseline, 3th weeks
|
The Turkish version of SF-36 was validated by Koçyiğit et al.
It consists of 36 items and 8 subscales assessing physical and mental health: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
|
Baseline, 3th weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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