- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03194490
Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
Loma Linda, California, Stati Uniti, 92354
- Loma Linda U
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
|
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.
|
Comparatore attivo: The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
|
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 . |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Cervical Range of Motion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Numeric Pain Rating Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Everett B Lohman, Loma Linda U
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5160230
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore al collo
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
Prove cliniche su combined intervention group
-
Sarah MorrowLawson Health Research InstituteCompletato
-
University of TulsaTerminatoSuicidio, tentatoStati Uniti
-
University of PittsburghReclutamentoDistrofia muscolare di DuchenneStati Uniti
-
M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
-
Lisbon Institute of Global Mental Health - LIGMHColumbia UniversityReclutamentoDisturbi psicotici | Schizofrenia | Disordine bipolare | Disturbo affettivo schizoidePortogallo
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
-
Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
-
University of MichiganNational Institute on Drug Abuse (NIDA)ReclutamentoUso di cannabisStati Uniti
-
Icahn School of Medicine at Mount SinaiReclutamento
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)ReclutamentoProfilassi pre-esposizione all'HIVStati Uniti