- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07596953
Efficacy of TECAR Therapy on Patient With Mechanical Neck Pain
Influence of TECAR Therapy on Cervical Mobility and Functional Disability in Patients With Mechanical Neck Pain: Randomized Control Study
The goal of this clinical trial is to evaluate the effectiveness of TECAR therapy in improving pain intensity, cervical range of motion, and functional disability in individuals with mechanical neck pain. It will also assess whether TECAR therapy provides additional clinical benefits compared with conventional physical therapy treatment. The main questions it aims to answer are:
- Does TECAR therapy reduce pain intensity in patients with mechanical neck pain?
- Does TECAR therapy improve cervical range of motion (CROM)?
- Does TECAR therapy reduce functional disability as measured by the Neck Disability Index (NDI)? Researchers will compare participants receiving TECAR therapy combined with conventional physical therapy to participants receiving conventional physical therapy alone to determine the effectiveness of TECAR therapy in managing mechanical neck pain.
Participants will:
- Attend scheduled treatment sessions during the study period
- Receive either TECAR therapy with conventional physical therapy or conventional physical therapy alone
- Undergo assessment of pain intensity, cervical range of motion, and neck disability before and after treatment
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Mechanical neck pain is one of the most common musculoskeletal disorders and is frequently associated with pain, restricted cervical mobility, and reduced functional performance, which may negatively affect daily activities and quality of life. Conventional physical therapy interventions are commonly used to manage mechanical neck pain; however, interest has recently increased in the use of TECAR therapy as a non-invasive modality that may enhance tissue healing, improve circulation, reduce pain, and restore function.
This single-blind randomized controlled trial aims to investigate the clinical effectiveness of TECAR therapy in individuals with mechanical neck pain. Participants who meet the eligibility criteria will be randomly assigned to either an experimental group receiving TECAR therapy in combination with conventional physical therapy or a control group receiving conventional physical therapy alone.
Outcome measures will be assessed before and after the intervention period and will include pain intensity, cervical range of motion (CROM), and functional disability using the Neck Disability Index (NDI). The study seeks to determine whether adding TECAR therapy to a conventional rehabilitation program provides superior improvements in pain reduction, cervical mobility, and functional outcomes in patients with mechanical neck pain.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mohamed A Abdel Ghafar, Ph.D.
- Telefonní číslo: 00966531513909
- E-mail: Pt12.jed@bmc.edu.sa
Studijní místa
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Al Zahraa
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Jeddah, Al Zahraa, Saudská arábie, 23623
- Saudi German Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Presence of neck pain for at least 3 months
- Limited cervical range of motion associated with neck pain
- Ability to understand and follow study instructions Willingness to participate and sign the informed consent form
Exclusion Criteria:
- History of cervical spine surgery or fracture
- Cervical radiculopathy or other neurological disorders
- Presence of inflammatory, rheumatic, or systemic diseases affecting the cervical spine
Severe cervical disc prolapse or spinal instability Current participation in another treatment program for neck pain Pregnancy Presence of pacemakers, metal implants, or contraindications to TECAR therapy Skin disorders or open wounds in the treatment area
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 |
|---|---|
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Experimentální: TECAR Therapy Group for Mechanical Neck Pain
Participants will receive TECAR therapy combined with a conventional physical therapy program for mechanical neck pain.
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Participants in the TECAR group received TECAR therapy in capacitive and resistive modes targeting superficial and deep tissues of the affected area.
Each session lasted 20-30 minutes, with intensity adjusted to produce a comfortable thermal effect without pain.
TECAR therapy was applied three times/week for 12 weeks, alongside a standardized exercise program identical to the control group.
Participants in the control group received a standardized therapeutic exercise program.
The program included stretching, strengthening, and functional exercises targeting the affected region.
Each session lasted 20-30 minutes and was performed three times/week for 12 weeks.
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Aktivní komparátor: Conventional Physical Therapy Group for Mechanical Neck Pain
Participants will receive a conventional physical therapy program only.
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Participants in the control group received a standardized therapeutic exercise program.
The program included stretching, strengthening, and functional exercises targeting the affected region.
Each session lasted 20-30 minutes and was performed three times/week for 12 weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity
Časové okno: Assessments will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Pain intensity was measured using the Visual Analog Scale (VAS) to assess changes in neck pain intensity throughout the study period.
The VAS is a self-reported pain assessment tool consisting of a 10-cm horizontal line, with scores ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Higher scores represent greater pain intensity and therefore a worse outcome.
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Assessments will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cervical Range of Motion (CROM)
Časové okno: Baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Measured using a Cervical Range of Motion device to evaluate changes in cervical flexion, extension, lateral flexion, and rotation.
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Baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Functional Disability
Časové okno: Assessment will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Functional disability was measured using the Neck Disability Index (NDI) to assess changes in functional limitations associated with mechanical neck pain.
The NDI is a self-administered questionnaire consisting of 10 items related to daily activities and pain.
Each item is scored from 0 to 5, with a total score ranging from 0 to 50, where 0 indicates no disability and 50 indicates complete disability.
Higher scores represent greater functional disability and therefore a worse outcome.
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Assessment will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BMCSGHTECAR
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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