Outcomes of Treatment Using the ERMI Shoulder Flexionater®
High Intensity Stretch Device
Bursite
+ Maladies des Articulations
+ Maladies musculo-squelettiques
Étude thérapeutique
Résumé
Date de début de l'étude : 25 juin 2019
Date à laquelle le premier participant a commencé l'étude.Study 1 - Adhesive Capsulitis Study (AC) Objective: The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. 1. Prospective randomized control trial 2. Sample size - 110 patients 3. Study Groups: 1. Group I - Physical Therapy Only 2. Group II - Flexionater® only 3. Group III - Flexionater® and Physical Therapy 4. Length of study - 2-year follow-up from last enrolled patient Study 2 - Postoperative Shoulder Stiffness Study (POS) Objective: The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment. 1. Prospective randomized control trial 2. Sample size - 90 enrolled patients 3. Study Groups: 1. Group I - Physical Therapy only 2. Group II - Flexionater® only 3. Group III - Flexionater® and Physical Therapy 4. Length of study - 2-year follow-up from last enrolled patient Study 3 - Secondary Surgery Study (SAM) Objective: The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. 1. Prospective randomized control trial 2. Sample size - 10 enrolled patients 3. Study Groups: 1. Group I Physical Therapy Only 2. Group II - - Flexionater® only 3. Group III - Flexionater® and Physical Therapy 4. Length of study - 2-year follow-up from last enrolled patient
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.210 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
For Study Group 1- Adhesive Capsulitis (AC) Inclusion Criteria: * Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients Exclusion Criteria: * a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder For Study Group 2 - Postoperative Shoulder Stiffness Study (POS) Inclusion Criteria: c. Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up? 1. \< 15 degrees external rotation with arm at side at 6 weeks post-op 2. OR \< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group Exclusion Criteria: a. Revision surgery b. Infection c. Rheumatoid arthritis 7\. Procedures included 1. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826) 2. ORIF Humerus fracture (23615) For Study Group 3, Secondary Surgery Study (SAM) Inclusion Criteria: 3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure Exclusion Criteria: a. Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder 7\. Procedures included 1. Manipulation under anesthesia (23700) 2. Lysis of adhesions (29825)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Foundation for Orthopaedic Research and Education
Tampa, United StatesOuvrir Foundation for Orthopaedic Research and Education dans Google Maps