TENS Versus Ultrasound With Exercise for Mechanical Neck Pain.
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Arm 1 Transcutaneous Electrical Nerve Stimulation (TENS) Therapeutic Exercise Heating Pad. Arm 2 Therapeutic Ultrasound Therapeutic Exercise Heating Pad.
- Кому может быть актуально
- Состояния в реестре: Mechanical Neck Pain. Базовые параметры: 18 лет — 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Therapeutic Benefit of Two Modalities TENS and Ultrasound Along With Exercises in the Management of Mechanical Neck Pain; A Randomized Clinical Trial
Обзор
This randomized clinical trial aims to compare the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and therapeutic ultrasound, both combined with therapeutic exercises, in the management of mechanical neck pain. A total of 44 participants male and female both with mechanical neck pain will be randomly allocated into two equal groups at the physiotherapy OPD of DOW Institute of Physical Medicine \& Rehabilitation, Dow University of Health Sciences, Karachi. Group A will receive TENS with exercise, while group B will receive ultrasound with the same exercise protocol. Both groups will receive 9 treatment sessions over 2 weeks. Outcomes will include pain intensity, functional disability, and cervical range of motion, assessed before and after the intervention.
Подробное описание
Mechanical Neck Pain is described as immediate or prolonged discomfort in cervical and shoulder regions, starting from the base of skull to the spine of scapula, this discomfort may extend down the arms and leading to reduction in the range of motion in the neck region and it occurred without any prior history of trauma, infection or systematic issues like fractures. Nonspecific neck pain is because of postural and mechanical reasons also known as Mechanical Neck Pain. Neck problems are not dangerous but these issues may cause discomfort and firmness. Much of the time neck pain is because of poor posture and flawed ergonomics at work area. Across various countries including Pakistan, Australia, the USA (New York), China, Brazil, and Central Saudi Arabia studies have identified neck pain prevalence among medical students ranging from 8.23% to 65%. Neck pain prevalence most commonly increases with age and greater among women as compared to men. According to studies 30%, 43% men and women respectively once in their lifetime experience neck pain, out of them10% men and 17% women experience chronic pain. Studies reported the 2nd most common musculoskeletal cause of disability globally. It is estimated that there are approximately 12 cases of Mechanical Neck Pain (MNP) per 1000 individuals seeking medical attention per year. Neck pain is a most frequent reason to seek medical attention from healthcare providers. Across the general population, neck pain affects 14% to 71% adults at various stages in their lives, among north Europeans 1-year greater prevalence as compared to Asian population. In general, worldwide population, 25% women and 16% men in Sweden experience neck pain annually. Iran reported 15% prevalence of neck pain in adults. While the exact cause of neck pain remains unclear, it is widely recognized as having a miscellaneous origin. Research indicates a strong correlation with factors such as depression, anxiety, migraines, sedentary lifestyle, disrupted sleep patterns, and smoking. The rising interest in neck pain because of its global prevalence which is 4.9%. Neck pain holds the 4th positions among condition causing disability when assessed in terms of years lived with some sort of pain and disability. Neck pain is responsible for causing disabilities of various severities and major cause of substantial medical expenses, productivity losses and economic burden.
Methodology:
Participants who are diagnose and referred to the Physiotherapy Outpatient Department (OPD) of the DOW Institute of Physical Medicine \& Rehabilitation at Dow University of Health Sciences, OJHA Campus, will be included in the study. All eligible participants will be thoroughly informed about the study through a structured Informed Consent Form. The researcher will introduce herself, explain the purpose, procedures, potential risks, and benefits of the study.
Participants will be allowed ample time to read the form, ask questions, and clarify any doubts. Those willing to participate will be asked to sign the consent form or provide a thumb impression. The screening and initial identification of eligible participants will be supervised by a senior physiotherapist. The informed consent process ensures compliance with ethical principles including autonomy, confidentiality, and the right to withdraw at any stage of the study without any penalty or impact on their ongoing care.
Sample size of 44 participants will be divided into two equal groups through simple random sampling technique through number generator table to ensure each participant has an equal chance of being selected and reduce selection biasness. The method used in the study comprise single blinded methodology.
Group A include 22 participants both male and females, will receive TENS (15 min), heating pad (10 min), followed by cervical active stretching (\~4 min) and isometric exercises (\~3 min), making a treatment subtotal of \~30 minutes, with the remaining time used for supervision, education, rest, and documentation (total 45 min/session).
Group B also include 22 participants, will receive therapeutic Ultrasound (10 min), heating pad (10 min), the same stretching (\~4 min) and isometric exercises (\~3 min), totaling \~27 minutes of treatment plus \~15 minutes for supervision and documentation (45 min/session).
Both groups will undergo 9 sessions over 2 weeks (6 consecutive sessions in week 1 and 3 alternate-day sessions in week 2).
Вмешательства
- Устройство Arm 1 Transcutaneous Electrical Nerve Stimulation (TENS) Therapeutic Exercise Heating Pad. Arm 2 Therapeutic Ultrasound Therapeutic Exercise Heating Pad
Participants will receive Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be conducted over 2 weeks. Participants will receive therapeutic ultrasound for 10 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be condu
Первичные конечные точки
- Visual Analog Scale (VAS) for Pain [Срок оценки: Baseline and after 2 weeks of treatment.]
Вторичные конечные точки (3)
- Muscle strength measured using Manual Muscle Testing (MMT) [Срок оценки: Baseline and after 2 weeks of treatment.]
- Pressure pain threshold measured using an algometer [Срок оценки: Baseline and after 2 weeks of treatment.]
- Neck disability measured using the Neck Disability Index (NDI) [Срок оценки: Baseline and after 2 weeks of treatment.]
Критерии участия
Критерии включения
- Diagnosed and referred patients with mechanical neck pain.
- Participants with subacute or chronic neck pain.
- Participants willing to participate in the study.
- Participants with a Visual Analog Scale (VAS) pain score greater than 5 (moderate to severe pain).
Критерии исключения
- Participants with other musculoskeletal disorders, including rheumatoid arthritis, cervical spondylosis, spondylolisthesis, cervical radiculopathy, malignancy, or neurological disorders.
- Participants with a history of trauma or whiplash injury.
- Participants with chronic pain conditions such as fibromyalgia.
- Participants with vertigo or dizziness.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Dow University of Health Sciences — Karachi
Публикации
- Gumuscu BH, Kisa EP, Kara Kaya B, Muammer R. Comparison of three different exercise trainings in patients with chronic neck pain: a randomized controlled study. Korean J Pain. 2023 Apr 1;36(2):242-252. doi: 10.3344/kjp.22371. Epub 2023 Mar 21. PMID 36941087
- Puntumetakul R, Chatprem T, Saiklang P, Phadungkit S, Kamruecha W, Sae-Jung S. Prevalence and Associated Factors of Clinical Myelopathy Signs in Smartphone-Using University Students with Neck Pain. Int J Environ Res Public Health. 2022 Apr 17;19(8):4890. doi: 10.3390/ijerph19084890. PMID 35457756
- Rodriguez-Huguet M, Gil-Salu JL, Rodriguez-Huguet P, Cabrera-Afonso JR, Lomas-Vega R. Effects of Myofascial Release on Pressure Pain Thresholds in Patients With Neck Pain: A Single-Blind Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jan;97(1):16-22. doi: 10.1097/PHM.0000000000000790. PMID 28678033
- Weleslassie GG, Meles HG, Haile TG, Hagos GK. Burden of neck pain among medical students in Ethiopia. BMC Musculoskelet Disord. 2020 Jan 8;21(1):14. doi: 10.1186/s12891-019-3018-x. PMID 31914983
- Qing W, Shi X, Zhang Q, Peng L, He C, Wei Q. Effect of Therapeutic Ultrasound for Neck Pain: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2021 Nov;102(11):2219-2230. doi: 10.1016/j.apmr.2021.02.009. Epub 2021 Mar 17. PMID 33722564
- Vas J, Perea-Milla E, Mendez C, Sanchez Navarro C, Leon Rubio JM, Brioso M, Garcia Obrero I. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: a randomised controlled study. Pain. 2006 Dec 15;126(1-3):245-55. doi: 10.1016/j.pain.2006.07.002. Epub 2006 Aug 23. PMID 16934402
- Hany Sedeek Abousenna MM, Mohamed Shalaby AS, Chahal A, Shaphe A. A comparison of low dose ultrasound and far-infrared therapies in patients with mechanical neck pain. J Pak Med Assoc. 2021 Feb;71(2(A)):397-401. doi: 10.47391/JPMA.190. PMID 33819214
- Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4. PMID 34980079
Идентификаторы
NCT: NCT07723586 · IRB-4390/DUHS/Approval/2025/84