Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.

NCT06497348

Capsulitis of Shoulder Frozen Shoulder

NOT_YET_RECRUITING NA

Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy in Patients With Frozen Shoulder

NCT03711409

Frozen Shoulder Shoulder Adhesive Capsulitis

COMPLETED NA

Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder

NCT01817348

Frozen Shoulder Adhesive Capsulitis

COMPLETED NA

Frozen Shoulder Single Arm Prospective Study

NCT04687735

Frozen Shoulder

UNKNOWN NA

Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder

NCT06377644

Frozen Shoulder

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adhesive Capsulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

equimolar oxygen-nitrous oxide mixture

equimolar oxygen-nitrous oxide mixture

Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.

Group Type EXPERIMENTAL

equimolar oxygen-nitrous oxide mixture

Intervention Type DRUG

Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.

Placebo

Patients randomized to this arm will have the placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Kinesitherapy is performed with a mask by which patient inhales a placebo.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

equimolar oxygen-nitrous oxide mixture

Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.

Intervention Type DRUG

Placebo

Kinesitherapy is performed with a mask by which patient inhales a placebo.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No