Adhesive Capsulitis
Conditions
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.
Interventions
DRUGequimolar oxygen-nitrous oxide mixture
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
DRUGPlacebo
Kinesitherapy is performed with a mask by which patient inhales a placebo.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Constant Score using treatment as compared to without treatment. | fifteen days of physical therapy | The Constant score questionnaire consists of 11 questions that result in a final score ranging from 0 to 100. The higher the test result, the more normally the shoulder is functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of active global anterior flexion of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of active global lateral flexion of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of active global abduction of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of active global internal rotation of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder | Final session on Day 15 | Range of motion in degrees |
| Pain at visits | At each session: final session on Day 15 | 0-100 visual analogue scale (VAS) |
| Pain induced during sessions | At each session: final session on Day 15 | 0-100 visual analogue scale (VAS) |
| Functional improvement | Day 7 | Disabilities of the Arm Shoulder and Hand scale (DASH) |
| Limitations posed to the physiotherapist activity due to patient pain at each session | At each session: final session on Day 15 | Likert six-point scale (none, to extremely high) |
| patient satisfaction | At each session: final session on Day 15 | 0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions |
| Change in the Constant Score using treatment as compared to without treatment | Day 7 | — |
| Patient Quality of life | Day 1 | Medical Outcome Study Short Form-36 (MOS-SF36) score |
| Antalgic intake | Until end of study (Day 180) | Discriptively noted |
| Change in kinetics at final session since baseline of passive global abduction of the shoulder | Final session on Day 15 | Range of motion in degrees |
Countries
France
Outcome results
None listed