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Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain

9 октября 2019 г. обновлено: Everett Lohman, Loma Linda University
The purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

All recruited participants will sign a statement of informed consent. Subjects were randomly divided into two groups (combined intervention group and standard intervention group). The following questionnaires were completed in the following order: Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GROC). Next, Cervical Range of Motion (ROM) and Pain threshold were measured for both groups. The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise). The standard intervention group received cervical mobilization and home program (ROM exercises).

Тип исследования

Интервенционный

Регистрация (Действительный)

43

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 60 лет (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks

Exclusion Criteria:

  • Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
Другой: combined intervention group
The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy. The cervical passive mobilization were selected by the physical therapist based on the participant's condition. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral.
Активный компаратор: The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
Другой: The standard intervention

The standard intervention group will receive cervical mobilization and home program (ROM exercises).

Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.

Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral .

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Cervical Range of Motion
Временное ограничение: Participants ROM measurement at baselines
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
Participants ROM measurement at baselines
Cervical Range of Motion
Временное ограничение: Participants ROM measurement at week 2
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
Participants ROM measurement at week 2
Cervical Range of Motion
Временное ограничение: Participants measurement at week four
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
Participants measurement at week four
Cervical Range of Motion
Временное ограничение: Participants ROM measurement at week 8
The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
Participants ROM measurement at week 8

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Numeric Pain Rating Scale
Временное ограничение: NPRS score at baseline
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand. The standard error is correct as stated.
NPRS score at baseline
Numeric Pain Rating Scale
Временное ограничение: NPRS score at week two
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
NPRS score at week two
Numeric Pain Rating Scale
Временное ограничение: NPRS score at week four
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
NPRS score at week four
Numeric Pain Rating Scale
Временное ограничение: NPRS score at week eight
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
NPRS score at week eight
Neck Disability Index
Временное ограничение: NDI score at baseline
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
NDI score at baseline
Neck Disability Index
Временное ограничение: NDI score at week two
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
NDI score at week two
Neck Disability Index
Временное ограничение: NDI score at week four
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
NDI score at week four
Neck Disability Index
Временное ограничение: NDI score at week eight
Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
NDI score at week eight
Global Rating of Change
Временное ограничение: GROC score at week two
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively. The points are scores on a scale (-7-0-+7 = 15 point scale).
GROC score at week two
Global Rating of Change
Временное ограничение: GROC score at week four
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.
GROC score at week four
Global Rating of Change
Временное ограничение: GROC score at week eight
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.
GROC score at week eight
Pressure Pain Threshold
Временное ограничение: Pressure Pain Threshold score at baseline
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.
Pressure Pain Threshold score at baseline
Pressure Pain Threshold
Временное ограничение: Pressure Pain Threshold score at week two
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Pressure Pain Threshold score at week two
Pressure Pain Threshold
Временное ограничение: Pressure Pain Threshold score at week four
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Pressure Pain Threshold score at week four
Pressure Pain Threshold
Временное ограничение: Pressure Pain Threshold score at week eight
Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
Pressure Pain Threshold score at week eight

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Loma Linda University

Следователи

  • Главный следователь: Everett B Lohman, Loma Linda U

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

24 августа 2016 г.

Первичное завершение (Действительный)

8 января 2018 г.

Завершение исследования (Действительный)

8 января 2018 г.

Даты регистрации исследования

Первый отправленный

13 июня 2017 г.

Впервые представлено, что соответствует критериям контроля качества

20 июня 2017 г.

Первый опубликованный (Действительный)

21 июня 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 октября 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 октября 2019 г.

Последняя проверка

1 октября 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 5160230

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования combined intervention group

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