- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06507761
Termoterapia nel dolore al collo acuto non specifico
Confronto dell'effetto a breve termine delle applicazioni di termoterapia superficiale in uno studio controllato randomizzato sul dolore al collo acuto non specifico
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Turkey
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Istanbul, Turkey, Turchia (Türkiye), +90
- Nuray ALACA
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Istanbul, Turkey, Turchia (Türkiye), 34752
- Acibadem University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Being diagnosed with nonspecific neck pain by a doctor,
- To be between the ages of 18-65,
- Neck pain lasting for less than 3 month
- No previous neck or shoulder surgery,
- No shoulder pain due to any cause,
- A tumour or inflammatory disease underlying the neck pain not to be found,
- A clinically underlying stenosis or discogenic problem not to be present.
- Negative results from the following clinical examination tests;
Spurling test, Lhermitte test, Cervical distraction test, Adson test,
Exclusion Criteria:
- Not meeting the inclusion criteria,
- Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- Systemic rheumatological or metabolic diseases or cancer
- Refusal to participate in the study,
- Failure to complete treatment,
- Having any neurological problem
- Severe psychological illnesses
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 |
|---|---|
|
Comparatore fittizio: Gruppo Sham
|
An unrefrigerated room temperature Cold Pack will be wrapped in a towel and applied to the patient's posterior neck and back for 15 minutes while the patient is lying face down. |
|
Comparatore attivo: Gruppo di impacchi caldi
|
Hot pack (55-60 degrees) application will be wrapped in a towel and applied to the back side neck and back of the patient for 15 minutes while the patient is lying face down. |
|
Comparatore attivo: Gruppo impacco freddo
|
Cold pack application (2-4 degrees) will be wrapped in a towel and applied to the patient's back side neck and back for 15 minutes while the patient is lying prone. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Numerical Rating Scale (NPRS-11)
Lasso di tempo: Change from baseline pain score at 3th day
|
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
Change from baseline pain score at 3th day
|
|
Range of Motion
Lasso di tempo: Change from baseline range of motion at 3th day
|
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures |
Change from baseline range of motion at 3th day
|
|
Global Rating of Change scale (Patient Satisfaction)
Lasso di tempo: Global Rating of Change assessed on the third day relative to baseline.
|
All participants were asked to rate their condition on the third day compared with baseline by indicating whether they had improved significantly, improved slightly, remained unchanged, deteriorated slightly, or deteriorated significantly, on a scale ranging from -2 to +2, with higher scores indicating greater improvement. |
Global Rating of Change assessed on the third day relative to baseline.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Neck disability index
Lasso di tempo: Change from baseline disability scale at 3th day
|
Neck-related disability was assessed using the 10-item Neck Disability Index (NDI). Each item is scored from 0 (no disability) to 5 (maximum disability), resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. |
Change from baseline disability scale at 3th day
|
|
Pressure Pain Threshold
Lasso di tempo: Change from baseline Pressure Pain Threshold at 3th day
|
Pressure pain threshold (PPT) was assessed using a handheld digital pressure algometer at 12 standardized bilateral anatomical sites, including cervical paravertebral and upper trapezius regions. Pressure was applied perpendicular to the skin at a rate of approximately 0.5 kg/cm²/s until the participant first reported that the sensation had changed from pressure to pain. Three measurements were obtained at each site, and the mean values were used to derive global cervical and trapezius pressure pain threshold scores. Higher PPT values indicated lower mechanical pain sensitivity. |
Change from baseline Pressure Pain Threshold at 3th day
|
Collaboratori e investigatori
Sponsor
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
- 2024/9/340
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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 .