- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02493127
The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
Objectives:
To determine the association between priming and measurements of hand function such as grip strength
Primary null hypothesis:
There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.
Secondary null hypotheses:
There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service
Exclusion Criteria:
- Unable to complete enrollment forms due to mental status or language problem
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Standard PCS
Grip strength measurements and completes standard PCS
|
Subject completes the standard version of the PCS Questionnaire
Research Assistant takes Grip Strength Measurements
|
|
Eksperimentell: Positive PCS
Grip strength measurements and completes positively adjusted PCS
|
Research Assistant takes Grip Strength Measurements
Subject completes the positively-adjusted version of the PCS Questionnaire
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Tidsramme: enrollment
|
The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking.
The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.
|
enrollment
|
|
Positive Pain Catastrophizing Scale (PCS)
Tidsramme: enrollment
|
The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking.
The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.
|
enrollment
|
|
Difference in Grip Strength Measured With Dynamometer
Tidsramme: Day 1
|
Difference in Grip strength of the non-affected hand after completing intervention.
Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1).
The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
|
Day 1
|
|
Difference in Grip Strength Measured With Dynamometer
Tidsramme: Day 1
|
Difference in Grip strength of the injured hand after completing intervention.
Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1).
The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
|
Day 1
|
|
Difference in Grip Strength Measured With Dynamometer
Tidsramme: Day 1
|
Difference in Grip strength of both hands after completing intervention.
Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1).
The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
|
Day 1
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Andre studie-ID-numre
- 2015P000879
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