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

NCT01087229 | Completed Phase 4

• 2 other identifiers: PHRC-I/2008/AD-012008-007161-23
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

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.

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

• Change in the Constant Score using treatment as compared to without treatment.

  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.

  fifteen days of physical therapy

Secondary Outcomes (29)

• Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder

  Final session on Day 15

• Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder

  Final session on Day 15

• Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder

  Final session on Day 15

• Change in kinetics at final session since baseline of active global anterior flexion of the shoulder

  Final session on Day 15

• Change in kinetics at final session since baseline of active global lateral flexion of the shoulder

  Final session on Day 15

Study Arms (2)

equimolar oxygen-nitrous oxide mixture

EXPERIMENTAL

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

Drug: equimolar oxygen-nitrous oxide mixture

Placebo

PLACEBO COMPARATOR

Patients randomized to this arm will have the placebo.

Drug: Placebo

Interventions

equimolar oxygen-nitrous oxide mixture DRUG

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

equimolar oxygen-nitrous oxide mixture

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

Unité Rééducation Réadaptation Locomotrice

Le Grau-du-Roi, Gard, 30240, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, 63118, France

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

Centre Hélio Marin

Vallauris, 06223, France

Location

Related Publications (2)

• Dupeyron A, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Nitrous oxide provided during intensive physiotherapy for shoulder adhesive capsulitis does not improve function: A randomised controlled trial. Ann Phys Rehabil Med. 2024 Apr;67(3):101803. doi: 10.1016/j.rehab.2023.101803. Epub 2023 Dec 19.

  PMID: 38118247 RESULT

• 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.

  PMID: 30099150 DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Arnaud Dupeyron, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: September 2, 2013
• Study Completion: September 2, 2013
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (5)