- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03194490
Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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California
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Loma Linda, California, Egyesült Államok, 92354
- Loma Linda U
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
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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.
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Aktív összehasonlító: The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
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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 . |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Cervical Range of Motion
Időkeret: Participants ROM measurement at baselines
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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.
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Participants ROM measurement at baselines
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Cervical Range of Motion
Időkeret: Participants ROM measurement at week 2
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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.
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Participants ROM measurement at week 2
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Cervical Range of Motion
Időkeret: Participants measurement at week four
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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.
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Participants measurement at week four
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Cervical Range of Motion
Időkeret: Participants ROM measurement at week 8
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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.
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Participants ROM measurement at week 8
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Numeric Pain Rating Scale
Időkeret: NPRS score at baseline
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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.
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NPRS score at baseline
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Numeric Pain Rating Scale
Időkeret: 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.
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NPRS score at week two
|
Numeric Pain Rating Scale
Időkeret: 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
Időkeret: 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.
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NPRS score at week eight
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Neck Disability Index
Időkeret: NDI score at baseline
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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.
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NDI score at baseline
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Neck Disability Index
Időkeret: NDI score at week two
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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.
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NDI score at week two
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Neck Disability Index
Időkeret: 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.
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NDI score at week four
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Neck Disability Index
Időkeret: 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.
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NDI score at week eight
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Global Rating of Change
Időkeret: GROC score at week two
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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).
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GROC score at week two
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Global Rating of Change
Időkeret: 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
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Global Rating of Change
Időkeret: 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.
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GROC score at week eight
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Pressure Pain Threshold
Időkeret: Pressure Pain Threshold score at baseline
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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.
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Pressure Pain Threshold score at baseline
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Pressure Pain Threshold
Időkeret: Pressure Pain Threshold score at week two
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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.
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Pressure Pain Threshold score at week two
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Pressure Pain Threshold
Időkeret: Pressure Pain Threshold score at week four
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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.
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Pressure Pain Threshold score at week four
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Pressure Pain Threshold
Időkeret: Pressure Pain Threshold score at week eight
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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.
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Pressure Pain Threshold score at week eight
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Everett B Lohman, Loma Linda U
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 5160230
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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