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Идёт набор NCT06587399

Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment

Без фазы С лечением Shoulder Impingement Shoulder Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Manual therapy treatment, Radial shock wave treatment.
Кому может быть актуально
Состояния в реестре: Shoulder Impingement, Shoulder Pain. Базовые параметры: 18 лет — 80 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical Trial

Обзор

Subacromial syndrome represents the third leading cause of pain in the general population. There is no clear pathophysiological explanation, nor a specific treatment. Manual therapy stands out as one of the reference treatments for this disease, however, it is complex to develop a specific protocol. On the other hand, shock waves have still not received adequate attention in the treatment of this pathology. The aim of this study will focus on using manual treatment using ischemic pressure, joint mobilizations and myofascial techniques in comparison to shock wave therapy to determine which is more effective. This study will be a randomized, single-blind clinical trial with third-party evaluation. In it 88 subjects suffering from subacromial syndrome will participate. 44 patients will receive treatment through manual therapy over 6 weeks and other 44 patients through low-med energy radial shock waves for 6 weeks. All subjects will complete their treatment with a 12-week home-based therapeutic exercise program. The main endpoint of the study will be pain measured using the visual analogue scale (VAS) in motion. Pain will also be assessed using the VAS scale at rest and overnight. The Spadi Spanish version questionnaire will be used, shoulder strength will be measured using a handheld dynamometer and the ranges of motion will be measured. Data will be measured before and one year after treatment.

Вмешательства

  • Другое Manual therapy treatment
    Joint mobilization techniques will be applied to the shoulder joint complex, adapted to the subjects' degree of irritability. The muscular trigger points of the shoulder muscles will be treated using a pressure release technique applied for 60 seconds. In addition, the subjects will carry out a 12-week home-based therapeutic exercise program.
  • Другое Radial shock wave treatment
    The treatment will be carried out with 1 session per week for 6 weeks. For this purpose, a radial shock wave generator will be used, at a frequency of 8 to 12 Hz, 2000 pulses/session and with a pressure of 2.5 to 4.0 bar. Between 3 and 5 points will be treated per session: insertion of the supraspinatus muscle, dorsolateral area under the acromion and a maximum of 3 trigger points of the rotator cuff muscles. In addition, the subjects will carry out a 12-week home therapeutic exercise program.

Первичные конечные точки

  • Shoulder Pain [Срок оценки: Change from Baseline pain at 12 month.]
Вторичные конечные точки (4)
  • Disability [Срок оценки: Change from Baseline pain at 12 month.]
  • Muscle Force [Срок оценки: Change from Baseline pain at 12 month.]
  • Graded Chronic Pain Scale (CPGS) [Срок оценки: Change from Baseline pain at 12 month.]
  • Shoulder range of movement (ROM) [Срок оценки: Change from Baseline pain at 12 month.]

Критерии участия

Критерии включения

  • Unilateral shoulder pain with no history of trauma.
  • Pain of at least 4/10 on the Visual Analogue Scale for a minimum period of 3 months.
  • Be positive in at least 3 of the following 5 tests: painful arc test, Neer impingement test, Hawkins-Kennedy test, Jobe test, external rotation test against resistance for the infraspinatus tendon.

Критерии исключения

  • Presence of red flags.
  • Diagnosis of shoulder instability.
  • Diagnosis of frozen shoulder.
  • Diagnosis of complete rupture of the common rotator cuff tendon.
  • Diagnosis of cervical radiculopathy.
  • Diagnosis of whiplash.
  • Diagnosis of degenerative disease of the glenohumeral joint.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Alcalá University — Alcalá de Henares

Идентификаторы

NCT: NCT06587399 · CEIM/2024/3/053

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗