- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04819139
Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis
Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).
The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Málaga
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Malaga, Málaga, Spania, 29012
- Raquel Cantero-Téllez
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises
Exclusion Criteria:
- Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Thumb exercises +orthosis
Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. |
Active thumb exercises
Reeducation in the activities daily life
Used of a thumb orthosis
|
|
Eksperimentell: Thumb exercises +orthosis+ proprioceptive program exercises
Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes. In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. In addiction, patients will received a proprioceptive program exercises using also a online program with a laptop. |
Active thumb exercises
Reeducation in the activities daily life
Used of a thumb orthosis
Specific proprioception exercises
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity
Tidsramme: baseline - 2 days
|
Pain intensity will be measured according to the visual analog scale (VAS).
The VAS scale is a unidimensional measure of pain intensity and is widely used in adult populations, including those with rheumatic diseases.
Sensitivity and reliability of the instrument are well defined including sensitivity to change in pain for patients with chronic inflammatory or degenerative joint pain
|
baseline - 2 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
JPS
Tidsramme: baseline - 2 days
|
For measurement of JPS, the subjects were blindfolded and repositioned their thumb to a target position, which was determined by the examiner previously
|
baseline - 2 days
|
|
FS
Tidsramme: baseline- 2 days
|
For force sense, participants should reproduce pinch force measure with dynamometer.
|
baseline- 2 days
|
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
- 2021-THUMB-1
Plan for individuelle deltakerdata (IPD)
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