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L'essai clinique NCT06536114 (CRISP) pour Douleur à l'épaule, Blessures à l'épaule est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Vue en carte
Efficacité d'un parcours clinique basé sur des critères pour la réhabilitation des blessures à l'épaule (CRISP) 250 Randomisé Novateur
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06536114 (CRISP) est une étude interventionnel pour Douleur à l'épaule, Blessures à l'épaule. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2025, avec un objectif de 250 participants. Dirigée par United States Naval Medical Center, San Diego, l'étude devrait être terminée d'ici le 30 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 août 2024.
Résumé succinct
The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. The main questions it aims to answer are:
- Are there differences in patient reported outcomes between participants who undergo the criteria-based rehab...
Description détaillée
Without a data-driven pathway to assess and rehabilitate shoulder injuries, clinicians may be using time rather than criteria to guide rehabilitation and clearance for return to duty. Delayed return to duty and subsequent injury or surgery contribute to time lost from duty, negative financial implications for the Military Health System, and adversely affect Service members' mental health and quality of life. Therefor...Afficher plus
Titre officiel
Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
Pathologies
Douleur à l'épauleBlessures à l'épaulePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- CRISP
- NMCSD.0024.0048
Numéro NCT
Date de début (réel)
2025-03-01
Dernière mise à jour publiée
2024-08-02
Date de fin (estimée)
2027-08-30
Inscription (estimée)
250
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
shoulder
return-to-duty
physical therapy
rehabilitation
return-to-duty
physical therapy
rehabilitation
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalCriteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. | CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, to facilitate joint protection; strength and endurance, to optimize functional capacity; and power, to prepare the Service member for returning to previous level of duty. |
Comparateur actifStandard of Care The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. | Standard de soins The Standard of Care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Penn Shoulder Score | Patient-reported outcome with shoulder pain, satisfaction, and function subscales | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Referral to Surgical Intervention | Participant was referred to surgical invention for their shoulder injury. | 3-, 6-, 12- months |
Patient-Reported Outcomes Measurement Information System (PROMIS®) | Patient-reported outcome measuring physical, mental, and social health among individuals with various chronic conditions. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF) | The OSPRO-YF is a 10-item screening tool which incorporates several psychosocial domains, namely, mood, fear avoidance, and positive affect-coping. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire | The Readiness Rehab Questionnaire assesses deployment readiness, containing questions including, "if called for a 6 month deployment today, my confidence to travel to/within a combat zone, carry/wear/use all required equipment and/or weapon, and perform required military duties for the duration of the 6 month deployment is:" and "my confidence to do my specific military duties with well managed pain is:\_\_", both scored on 0-100 scales. | Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.
- The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.
United States Naval Medical Center, San Diego- ⚕️Br...
Contact central de l'étude
Contact: Marisunta Pontillo, PhD, 215-266-1904, [email protected]
Contact: Sara Gorczynski, 619-532-9704, [email protected]
1 Centres de l'étude dans 1 pays
California
Naval Medical Center San Diego, San Diego, California, 92134, United States