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Adhesive CapsulitisPhase 4MEOPANCT01087229

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

A Phase 4 study testing equimolar oxygen-nitrous oxide mixture in people with Adhesive Capsulitis, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adhesive Capsulitis
What is being tested?
equimolar oxygen-nitrous oxide mixture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
5 sitesFrance
Study dates
Mar 2010to 2 Sep 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63118

  • Unité Rééducation Réadaptation Locomotrice

    Le Grau-du-Roi, Gard, 30240

  • CHU Lapeyronie

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, Gard, 30029

  • Centre Hélio Marin

    Vallauris, 06223

Other trials in France

About this study

Official title: Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis

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.

Being tested
equimolar oxygen-nitrous oxide mixture, Placebo
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • equimolar oxygen-nitrous oxide mixtureDrug

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

  • PlaceboDrug

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

Study groups in NCT01087229
Study groupRoleWhat they receive
equimolar oxygen-nitrous oxide mixtureExperimentalequimolar oxygen-nitrous oxide mixture Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Receives: Drug: equimolar oxygen-nitrous oxide mixture
PlaceboPlacebo comparatorPatients randomized to this arm will have the placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: fifteen days of physical therapy

Secondary outcomes (29)

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

    Range of motion in degrees

    Measured: Final session on Day 15

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

    Range of motion in degrees

    Measured: Final session on Day 15

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

    Range of motion in degrees

    Measured: Final session on Day 15

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

    Range of motion in degrees

    Measured: Final session on Day 15

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

    Range of motion in degrees

    Measured: Final session on Day 15

  6. Change in kinetics at final session since baseline of active global abduction of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  7. Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  8. Change in kinetics at final session since baseline of active global internal rotation of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  9. Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  10. Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  11. Change in kinetics at final session since baseline of passive global abduction of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  12. Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder

    Range of motion in degrees

    Measured: Final session on Day 15

  13. Pain at visits

    0-100 visual analogue scale (VAS)

    Measured: At each session: final session on Day 15

  14. Pain induced during sessions

    0-100 visual analogue scale (VAS)

    Measured: At each session: final session on Day 15

  15. Functional improvement

    Disabilities of the Arm Shoulder and Hand scale (DASH)

    Measured: Day 7

  16. Functional improvement

    Disabilities of the Arm Shoulder and Hand scale (DASH)

    Measured: Day 15

  17. Functional improvement

    Disabilities of the Arm Shoulder and Hand scale (DASH)

    Measured: Day 45

  18. Functional improvement

    Disabilities of the Arm Shoulder and Hand scale (DASH)

    Measured: Day 180

  19. Limitations posed to the physiotherapist activity due to patient pain at each session

    Likert six-point scale (none, to extremely high)

    Measured: At each session: final session on Day 15

  20. patient satisfaction

    0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions

    Measured: At each session: final session on Day 15

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

    Measured: Day 7

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

    Measured: Day 45

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

    Measured: Day 180

  24. Patient Quality of life

    Medical Outcome Study Short Form-36 (MOS-SF36) score

    Measured: Day 1

  25. Patient Quality of life

    MOS-SF36 score

    Measured: Day 7

  26. Patient Quality of life

    MOS-SF36 score

    Measured: Day 15

  27. Patient Quality of life

    MOS-SF36 score

    Measured: Day 45

  28. Patient Quality of life

    MOS-SF36 score

    Measured: Day 180

  29. Antalgic intake

    Discriptively noted

    Measured: Until end of study (Day 180)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completion2 Sep 2013
  4. Study completion2 Sep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01087229
Sponsor's protocol ID
PHRC-I/2008/AD-01
Other IDs
2008-007161-23, 2008
Acronym
MEOPA
Status last verified
Nov 2025
First submitted
15 Mar 2010
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38118247

  • 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.

    PubMed 30099150

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing equimolar oxygen-nitrous oxide mixture in people with Adhesive Capsulitis, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Constant Score using treatment as compared to without treatment. (time frame: fifteen days of physical therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087229, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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