Thermotherapie bij acute niet-specifieke nekpijn
Vergelijking van het kortetermijneffect van oppervlakkige thermotherapietoepassingen in een gerandomiseerd gecontroleerd onderzoek met acute niet-specifieke nekpijn
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Turkey
-
Istanbul, Turkey, Turkije (Türkiye), +90
- Nuray ALACA
-
Istanbul, Turkey, Turkije (Türkiye), 34752
- Acibadem University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Sham-vergelijker: Sham-groep
|
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. |
|
Actieve vergelijker: Hotpack-groep
|
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. |
|
Actieve vergelijker: Cold Pack-groep
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The Numerical Rating Scale (NPRS-11)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neck disability index
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024/9/340
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .