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Manipulation under anesthesia versus conservative treatment in stage two of a frozen shoulder: a randomized controlled trial

Manipulation under anesthesia versus conservative treatment in stage two of a frozen shoulder: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21101
Enrollment
84
Registered
2017-01-15
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen shoulder, adhesive capsulitis

Interventions

Manipulation under anesthesia + Physiotherapy

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: This study focusses on patients with a clinical diagnosis of a stage two FS. This is defined as symptoms of pain and stiffness, predominantly in one shoulder, persisting ≥ 3 months, without preliminary trauma which led to an anatomic abnormality. Characteristically, the pain is most severe at the end of the range of motion. Pain must be diminished compared to the maximum amount of pain in stage one of the condition. In order to be eligible to participate in this trial, patients must meet all of the following criteria: - Age  18 years and ≤ 70 years - Restriction of passive motion in the glenohumeral joint of ≥30° in external rotation and at least a second plane of movement with ≥30°restriction (compared to the contra-lateral side) - Unsuccessful conservative therapy within the previous 3 months

Exclusion criteria

Exclusion criteria: If any of the following criteria will apply, patients will be excluded from participation: - Numeric Pain Rating Scale at rest ≥ 7 - Onset of symptoms ≥ 1 year ago - Osteoarthritis of the glenohumeral joint, Kellgren-Lawrence osteoarthritis grading scale ≥ 2 - Previous surgery to the shoulder - Systemic inflammatory joint disease - Evidence of a complete rotator cuff tear on physical examination, ultrasound images or MRI - Neurological disorders of the upper limb - Therapeutic anticoagulation which can not be interrupted without bridging therapy - Other known shoulder pathology such as infection or tumor - Contra-indication to corticosteroid injection, allergy to contrast or local anaesthetic - Inability to give informed consent and fill out questionnaires

Design outcomes

Primary

MeasureTime frame
SPADI

Secondary

MeasureTime frame
OSS, NRS, EQ 5D, ROM, WORQ-UP

Contacts

Public ContactBertram The

Amphia ziekenhuis

bthe@amphia.nlTel: 076-5953080

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)