Skip to main content
OpenTrials
Completed

NCT Number: NCT01087229

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unité Rééducation Réadaptation Locomotrice, Le Grau-du-Roi, Gard, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

equimolar oxygen-nitrous oxide mixture

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

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

    Time frame: Final session on Day 15

    Range of motion in degrees

  13. Pain at visits

    Time frame: At each session: final session on Day 15

    0-100 visual analogue scale (VAS)

  14. Pain induced during sessions

    Time frame: At each session: final session on Day 15

    0-100 visual analogue scale (VAS)

  15. Functional improvement

    Time frame: Day 7

    Disabilities of the Arm Shoulder and Hand scale (DASH)

  16. Functional improvement

    Time frame: Day 15

    Disabilities of the Arm Shoulder and Hand scale (DASH)

  17. Functional improvement

    Time frame: Day 45

    Disabilities of the Arm Shoulder and Hand scale (DASH)

  18. Functional improvement

    Time frame: Day 180

    Disabilities of the Arm Shoulder and Hand scale (DASH)

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

    Time frame: At each session: final session on Day 15

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

  20. patient satisfaction

    Time frame: At each session: final session on Day 15

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

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

    Time frame: Day 7

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

    Time frame: Day 45

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

    Time frame: Day 180

  24. Patient Quality of life

    Time frame: Day 1

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

  25. Patient Quality of life

    Time frame: Day 7

    MOS-SF36 score

  26. Patient Quality of life

    Time frame: Day 15

    MOS-SF36 score

  27. Patient Quality of life

    Time frame: Day 45

    MOS-SF36 score

  28. Patient Quality of life

    Time frame: Day 180

    MOS-SF36 score

  29. Antalgic intake

    Time frame: Until end of study (Day 180)

    Discriptively noted

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: MEOPA

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 16, 2010
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.