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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00416117
Manual Physical Therapy and Exercise for Mechanical Neck Disorders
The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Prior to randomization, potential participants underwent a standardized history and examination of the cervical spine and upper quarter. We collected demographic information that included each patient's age; gender; medication use; imaging results; and the location, nature, and duration of symptoms. Self-report measures included the NDI and VAS pain scales. Physical exam measures included cervical range of motion measurements with a gravity inclinometer, passive accessory motion testing to assess cervical spine segmental mobility and pain provocation, an upper quarter neurological screening, and special tests commonly used to identify cervical impairments.
Participants meeting all inclusion criteria were randomized into one of two treatment groups: 1) manual physical therapy and exercise (MTE) or 2) minimal intervention (MI).
Patients in the MTE group received manual physical therapy interventions specifically targeted to impairments identified during the physical examination. Physical therapists chose manual interventions consisting of thrust and non-thrust joint manipulation/mobilization, muscle energy, and soft-tissue mobilization/stretching techniques that are commonly referenced and used in clinical practice. We provided all patients in the MTE group with a standard home exercise program of cervical retraction, deep neck flexor strengthening, and cervical rotation range of motion exercises.
Patients in the MI group received a basic treatment plan consistent with general practitioner care. We provided all patients with a basic regimen of postural advice, encouragement to maintain neck motion and daily activity levels, cervical rotation range of motion exercise, and instructions to continue any prescribed medication use. Minimalist physical therapy treatments consisted of sub-therapeutic pulsed (10%) ultrasound at 0.1w/cm2 for 10 minutes applied to the cervical spine and cervical rotation range of motion exercises. We provided these treatments to maintain the patients' expectations for physical therapy treatment and subsequent improvement, and to standardize the therapist-patient interaction time
The intervention period lasted 3 weeks with both groups receiving treatment twice weekly for up to 6 sessions. We standardized treatment time for both groups by using a one-hour initial evaluation and treatment session and thirty-minute follow-up treatment sessions. Patients did not have to complete all six visits if their symptoms had fully resolved. The treating therapist instructed and supervised all exercises to ensure proper patient technique and understanding.
We collected outcome measure data at baseline and at the patient's 3-week, 6-week and 1-year follow-ups. All outcome measures were collected by physical therapists that were blinded to treatment group allocation.
Tipo di studio
Iscrizione
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Texas
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Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
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Lackland Air Force Base, Texas, Stati Uniti, 78236
- Wilford Hall Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- primary complaint of neck pain, with or without unilateral upper extremity symptoms
- age greater than 18
- Neck Disability Index (NDI) score greater than or equal to 10 points
- Composite Visual Analog Scale (VAS) score greater than or equal to 30mm
- Eligible for military health care
- Reside within one hour of the military treatment facilities
- Possess sufficient English language skills to complete all questionnaires
Exclusion Criteria:
- whiplash injury within the past 6 weeks
- history of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
- pending legal action regarding their neck pain
- diagnosis of central cervical spinal stenosis
- bilateral upper extremity symptoms
- two positive neurological findings at the same nerve root level
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Indice di disabilità del collo
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Visual analog scale for neck pain
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Visual analog scale for upper extremity pain
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Global rating of change
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Misure di risultato secondarie
Misura del risultato |
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Treatment success rates based on GRC
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Additional healthcare utilization
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Michael J Walker, PT, DSc, Brooke Army Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C.2001.123
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 .
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