- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07847034
Comparative Effects of Multiple Angle Isometrics vs Standard Isometric Exercise in Lateral Epicondylitis
Comparative Effects of Multiple Angle Isometrics vs Standard Isometric Exercise in Lateral Epicondylitis:A Randomized Controlled Trial
Lateral Epicondylitis is one of the most common musculoskeletal conditions affecting 1-3% of population.Various terminologies are used to describe the disease like tendinitis of extensor carpi radialis brevis muscle (ECRB), periostitis and radial epicondylitis, lateral epicondylitis is still the most used terminology in literature. Research shows that LE mainly targets population which is active with poor nutrition habits and biomechanical faults thus affecting their job and social life. Pain is seen to be activity dependent and is triggered via excessive muscle activity.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Lateral epicondylitis (tennis elbow) is a frequent musculoskeletal condition, which involves pain, decreased grip strength and functional impairments due to a degeneration of the common extensor tendon. Despite the fact that isometric exercises are widely applied in the conservative treatment of lateral epicondylitis for their analgesic and strengthening properties, the most effective way of isometric training is not known. Multiple Angle Isometric (MAI) exercises are designed to engage a larger number of muscle fibres, increase neuromuscular activation and strengthen muscles across their entire range of motion than single angle isometric exercises.
The objective of this randomized controlled trial is to determine the effectiveness of the Multiple Angle Isometric (MAI) exercise to reduce pain, strengthen the wrist extensor muscles and increase upper limb function in patients with lateral epicondylitis when compared with the Standard Isometric (SI) exercise. The total number of participants is 36 with acute and sub acute lateral epicondylitis and will be sampled by non-probability purposive sampling and divided into two intervention groups by random allocation. All subjects will then be given the same initial treatment (hot pack and Transcutaneous Electrical Nerve Stimulation [TENS]) and then their respective exercise protocols. The intervention will take place three times a week for four weeks.
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity, Camry digital hand dynamometer to assess wrist extensor grip strength, and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess functional disability. Measurements will be taken pre- and post- and post-4 weeks after completion of the intervention. This study's results will give physiotherapists evidence for comparative effectiveness of the Multiple Angle Isometric and Standard Isometric exercise protocols to choose the most effective rehabilitation approach for lateral epicondylitis and optimal patient outcomes.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Punjab Province
-
Islamabad, Punjab Province, Пакистан, 4000
- Akbar Niazi Teaching Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
- Inclusion Criteria:
- Adults aged 25-35 years.
- Clinically diagnosed with acute or subacute lateral epicondylitis.
- Patients with ≥3 out of the following 5 positive clinical tests:
- Pain on palpation over the lateral epicondyle.
- Cozen's test positive.
- Mill's test positive.
- Maudsley's test positive.
- Acute or subacute clinical presentation.
- Willing to participate and provide written informed consent.
- Exclusion Criteria:
- Cervical spine disorders.
- Chronic lateral epicondylitis.
- Elbow deformity (fracture, previous surgery, contracture, etc.).
- Diabetes mellitus.
- Steroid injection at the lateral epicondyle within the previous 3 months.
- Rheumatoid arthritis or other neurological or muscular disorders.
- Previous elbow injury.
- Arthritic changes or calcifications around the elbow joint on radiographs. Malignancy.
- Pregnancy.
- Corticosteroid injection to the lateral epicondyle within the previous 6 weeks.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group A-Multiple Angle Isometrics (MAI)
Participants will be given baseline treatment with a hot pack and Transcutaneous Electrical Nerve Stimulation (TENS), then the exercises will be therapist-supervised multiple angle isometric wrist extensors at neutral, 15° and 30° wrist extension. There will be 3 sets of 10 repetitions for each exercise with 6-second hold (Weeks 1-2) followed by 12-second hold (Weeks 3-4) with 1-minute rest between sets, 3 times per week, 4 weeks total. |
Baseline treatment with a hot pack and Transcutaneous Electrical Nerve Stimulation (TENS), then the exercises will be therapist-supervised multiple angle isometric wrist extensors at neutral, 15° and 30° wrist extension. There will be 3 sets of 10 repetitions for each exercise with 6-second hold (Weeks 1-2) followed by 12-second hold (Weeks 3-4) with 1-minute rest between sets, 3 times per week, 4 weeks total. |
|
Активный компаратор: Group B - Standard Isometric Exercise
Participants will get the same baseline treatment (hot pack and TENS) and then do therapist supervised standard isometric wrist extensor exercises at a single (neutral) wrist position, with the same dosage and frequency (3 sets × 10 repetitions, 6-second hold during Weeks 1-2, 12-second hold during Weeks 3-4, 3 sessions per week for 4 weeks). |
Baseline treatment (hot pack and TENS) and then do therapist supervised standard isometric wrist extensor exercises at a single (neutral) wrist position, with the same dosage and frequency (3 sets × 10 repetitions, 6-second hold during Weeks 1-2, 12-second hold during Weeks 3-4, 3 sessions per week for 4 weeks). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Временное ограничение: Baseline, Week2 , Week 4
|
Assesses pain intensity using an 11-point numerical scale (0-10). |
Baseline, Week2 , Week 4
|
|
Grip Strength (Camry Digital Hand Dynamometer)
Временное ограничение: Baseline, 2 Week, 4 Week
|
Assess wrist extensor grip strength using a digital hand dynamometer. |
Baseline, 2 Week, 4 Week
|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Временное ограничение: Baseline, 2 Week, 4 Week
|
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a standardized tool that relies on patient-reported outcomes to evaluate function and disability in the upper limbs. It includes 30 questions designed to assess how symptoms affect daily tasks and physical abilities. Scores are calculated on a scale from 0 to 100, where higher values reflect more severe disability. |
Baseline, 2 Week, 4 Week
|
Соавторы и исследователи
Следователи
- Главный следователь: Maria Fatima Mughees, DPT, Akbar Niazi Teaching Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Ref no: IIUI/RERC/ADT/2026/02/
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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