Clinical trial NCT01087229: Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder
Official title: Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesive Capsulitis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.


Eligibility criteria: Inclusion Criteria:

* Affiliated with a social security system
* Has signed the consent form
* Patient has a painful, or initially painful but stable frozen shoulder (adhesive capsulitis): stiffening characterized by a passive loss of amplitude on three planes. This loss of amplitude is greater than or equal to 50% of controlateral amplitude when the controlateral shoulder is considered as normal. Otherwise, the loss of amplitude is greater than or equal to 50% of normal anatomical values.
* Radiography confirms the integrity of the glenohumeral interspace.

Exclusion Criteria:

* Intercurrent, evolving or unstable pathology: cancer, advanced cardio-vascular pathology, severe infection
* The patient is taking a treatment that may interfere with the study (eg corticoids, pain killers, chemotherapy)
* Contra-indication for physical therapy
* Coagulopathy
* Advanced diabetes mellitus, with neurological or joint complications
* Contra indication for the experimental treatment
* Pregnant or nursing women
* Patient's mental state prevents him/her from understanding the nature of the study, its objectives and potential consequences.
* Patient under guardianship
* Patient is in an exclusion period determined by a previous study
* Patient not able to follow protocol constraints or timetable
* Medical history of local infection, polyarthritis or neuropathy that might explain the shoulder pain.
* Absence of radiculopathy of cervical origin, of rotator cuff tears or evolving shoulder tendinopathy, of severe omarthrose

Primary outcomes:
measure: Change in the Constant Score using treatment as compared to without treatment.
timeFrame: fifteen days of physical therapy
Secondary outcomes:
measure: Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of active global anterior flexion of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of active global lateral flexion of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of active global abduction of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of active global internal rotation of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive global abduction of the shoulder
timeFrame: Final session on Day 15
measure: Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder
timeFrame: Final session on Day 15
measure: Pain at visits
timeFrame: At each session: final session on Day 15
measure: Pain induced during sessions
timeFrame: At each session: final session on Day 15
measure: Functional improvement
timeFrame: Day 7
measure: Functional improvement
timeFrame: Day 15
measure: Functional improvement
timeFrame: Day 45
measure: Functional improvement
timeFrame: Day 180
measure: Limitations posed to the physiotherapist activity due to patient pain at each session
timeFrame: At each session: final session on Day 15
measure: patient satisfaction
timeFrame: At each session: final session on Day 15
measure: Change in the Constant Score using treatment as compared to without treatment
timeFrame: Day 7
measure: Change in the Constant Score using treatment as compared to without treatment
timeFrame: Day 45
measure: Change in the Constant Score using treatment as compared to without treatment
timeFrame: Day 180
measure: Patient Quality of life
timeFrame: Day 1
measure: Patient Quality of life
timeFrame: Day 7
measure: Patient Quality of life
timeFrame: Day 15
measure: Patient Quality of life
timeFrame: Day 45
measure: Patient Quality of life
timeFrame: Day 180
measure: Antalgic intake
timeFrame: Until end of study (Day 180)
Other outcomes:
Locations:
city: Le Grau du Roi
country: France
facility: Unité Rééducation Réadaptation Locomotrice
state: Gard
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Montpellier Cedex 05
country: France
facility: CHU Lapeyronie
city: Vallauris
country: France
facility: Centre Hélio Marin
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupeyron A, Denarie M, Richard D, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial. Ann Phys Rehabil Med. 2019 Jan;62(1):43-48. doi: 10.1016/j.rehab.2018.07.007. Epub 2018 Aug 9.