- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02435979
Proximal Strengthening for the Management of Wrist Pain
Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This will be a non-blinded randomized controlled trial using a sample of consecutive patients with wrist pain. Patients who are referred to Nationwide Children's Hospital Hand therapy clinics with a primary complaint of wrist pain will be considered for this study.
Patients will be randomly assigned to one of two treatment groups; The proximal strengthening group or Traditional Hand Therapy Group. Both treatment groups will be evaluated and treated by the certified hand therapists for 2 sessions per week for 4 weeks. Both groups will receive similar treatment durations of 45-60 minutes per session based on each patient's individual needs.
Proximal strengthening group-The experimental proximal strengthening group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 20-30 minutes at each treatment session. Patients allocated to this treatment group will also perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
Traditional Hand Therapy Group This active comparator group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 45-60 minutes at each treatment session. Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ohio
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Columbus, Ohio, États-Unis, 43205
- Nationwide Children's Hospital Sports and Ortho PT Ortho Center
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Columbus, Ohio, États-Unis, 43213
- Nationwide Children's Hospital Sports and Ortho PT East Broad
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Dublin, Ohio, États-Unis, 43017
- Nationwide Children's Hospital Sports and Ortho PT Dublin
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Westerville, Ohio, États-Unis, 43082
- Nationwide Children's Hospital Sports and Ortho PT Westerville
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Wrist pain
Exclusion Criteria:
- <8 years of age
- any neurological disorder
- Juvenile rheumatoid arthritis
- juvenile idiopathic arthritis
- Wrist fractures < 16 weeks from date of injury or surgery
- Tendon repair
- Nerve injury or repair
- Inability to follow directions
- Inability to attend follow-up appointments
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Proximal strengthening + hand therapy
Patients in this group will perform traditional hand therapy for 30 minutes and proximal strengthening of the core, cervical spine, and shoulder complex for up to 30 minutes
|
Treatment can include stretching, motion, and strengthening exercises.
As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
Modalities for pain control and tissue mobility, and bracing or splinting if necessary.
All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
Patients will perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises.
Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises.
As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
|
Comparateur actif: Traditional hand therapy
This group will receive traditional hand therapy for 45-60 minutes each session.
|
Treatment can include stretching, motion, and strengthening exercises.
As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
Modalities for pain control and tissue mobility, and bracing or splinting if necessary.
All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Patient Rated Wrist Evaluation (PRWE) score
Délai: 4 weeks (From initial evaluation to discharge)
|
The PRWE is a 15 item self-report questionnaire which measure pain and function.
It has been found valid and reliable for measure changes in pain and function for patients with wrist pain.
The minimal clinical important difference of this scale is 14 (Sorensen, 2013).
|
4 weeks (From initial evaluation to discharge)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Grip Dynamometer strength
Délai: 4 weeks (From initial evaluation to discharge)
|
Grip strength will be measured using a Jamar dynamometer on 2nd setting with elbow at 90 deg and shoulder in adduction at the patient's side, with the patient seated.
Grip strength will be expressed as a percentage of body weight to account for differences in patients size and strength.
|
4 weeks (From initial evaluation to discharge)
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Alexander M, Franko OI, Makhni EC, Zurakowski D, Day CS. Validation of a modern activity hand survey with respect to reliability, construct and criterion validity. J Hand Surg Eur Vol. 2008 Oct;33(5):653-60. doi: 10.1177/1753193408093810.
- Metzler W, Kessler G, Benzer W, Mahr G. [Ophthalmological significance of stenosing carotid processes]. Wien Med Wochenschr. 1990 Jul 31;140(14):387-9. German.
- Emery K, De Serres SJ, McMillan A, Cote JN. The effects of a Pilates training program on arm-trunk posture and movement. Clin Biomech (Bristol, Avon). 2010 Feb;25(2):124-30. doi: 10.1016/j.clinbiomech.2009.10.003. Epub 2009 Oct 30.
- Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
- Kong YK. The effects of co-ordinating postures with shoulder and elbow flexion angles on maximum grip strength and upper-limb muscle activity in standing and sitting postures. Int J Occup Saf Ergon. 2014;20(4):595-606. doi: 10.1080/10803548.2014.11077077.
- MacDermid JC. Development of a scale for patient rating of wrist pain and disability. J Hand Ther. 1996 Apr-Jun;9(2):178-83. doi: 10.1016/s0894-1130(96)80076-7. No abstract available.
- Park JK, Buchholz B. Effects of work surface height on muscle activity and posture of the upper extremity during simulated pipetting. Ergonomics. 2013;56(7):1147-58. doi: 10.1080/00140139.2013.799234. Epub 2013 Jun 6.
- Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013 Apr;38(4):641-9. doi: 10.1016/j.jhsa.2012.12.032. Epub 2013 Mar 6.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB15-00251
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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