- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03673319
The Patient Expectation in Dry Needling and Analgesia
The Influence of Patient Expectation in Dry Needling Induced Analgesia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient.
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain".
DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Madrid
-
Alcala de Henares, Madrid, Spania, 28871
- Grupo Fisioterapia y Dolor
-
Alcalá De Henares, Madrid, Spania, 28805
- Institut Physiotherapy AND pain
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- neck pain (≥3 months of duration)
- VAS of 4-5 of pain.
- Presence of at least one active MTrP located at the upper trapezius.
Exclusion Criteria:
- Patients with previous cervical spine or shoulder surgery.
- Cervical spine radiculopathy or myelopathy.
- Systemic disease.
- Fibromyalgia.
- Pregnancy.
- Using sedative drugs.
- Needle phobia.
- Bleeding disorder.
- anticoagulant medication.
- Previous experience with DN for myofascial pain.
- Skin lesion and infection or inflammatory oedema at the MTrPs site
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Positive expectative
Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
|
DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
|
Eksperimentell: Neutral expectatives
Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
|
DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain Intensity: Visual Analog Scale (VAS)
Tidsramme: Change from Baseline at after intervention
|
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's current pain before, during DN and immediately after DN.
We will follow the paradigm of Conditioned pain modulation (CPM) paradigm.
CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the arm, at the opposite side from the affected upper trapezius.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain"(the best value) and the other end representing "worst pain" (the worse value).
Subjects will be asked to rate their current pain with a mark on the scale.
|
Change from Baseline at after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain Pressure Threshold (PPT)
Tidsramme: Change up 1 hour
|
The PPT serves to determine the sensitivity of hiperalgesic focus. The investigators will done it with one algometer. Lower values are a worse result. Higher values are a better result. |
Change up 1 hour
|
Dry needling pain
Tidsramme: Change up 1 hour
|
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's pain during DN intervention.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" (the best value) and the other end representing "worst pain" (the worse value).
Subjects will be asked to rate their current dry needling pain with a mark on the scale.
|
Change up 1 hour
|
Dry needling anxiety
Tidsramme: Change up 1 hour
|
The investigators use a Visual Analog Scale (VAS) to determine the anxiety of the patient during DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no anxiety"(the best value) and the other end representing "worst anxiety"(the worse value).
Subjects were asked to rate their current dry needling anxiety with a mark on the scale
|
Change up 1 hour
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEI18/087
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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