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


- candidate number26484
- NTR NumberNTR6182
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jan-2017
- Secondary IDsNL.56143.101.16 
- Public TitleManipulation under anesthesia versus conservative treatment in stage two of a frozen shoulder: a randomized controlled trial
- Scientific TitleManipulation under anesthesia versus conservative treatment in stage two of a frozen shoulder: a randomized controlled trial
- ACRONYMConDoor - trial
- hypothesisWe hypothesize that the course of the disease can be shortened with MUA with a quicker functional recovery and gain in range of motion and a subsequent faster return to work compared to conservative treatment.
- Healt Condition(s) or Problem(s) studiedFrozen shoulder
- Inclusion criteriaThis 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 criteriaIf 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2017
- planned closingdate31-dec-2019
- Target number of participants84
- InterventionsManipulation under anesthesia +
Physiotherapy
- Primary outcomeSPADI
- Secondary outcomeOSS, NRS, EQ 5D, ROM, WORQ-UP
- Timepoints1, 3 months and 1 year
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Bertram The
- CONTACT for SCIENTIFIC QUERIESDr. Bertram The
- Sponsor/Initiator Amphia hospital
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryRationale: Frozen shoulder (adhesive capsulitis) is a common cause of shoulder pain and affects approximately 2-4% of the general population. Idiopathic frozen shoulder is characterised by a spontaneous onset of pain and stiffness of the shoulder, especially a loss in external rotation, without a prior traumatic event. It is considered to be a self -limiting condition with a variable duration of 1-3 years. However, this is a prolonged period with a considerable amount of pain and disability in daily life. Traditionally, manipulation under anaesthesia is a well-established treatment procedure for a frozen shoulder if conservative treatment fails. However, it is also a controversial procedure because it might lead to complications as a fracture, dislocation or intra-articular injury. The reported complication rate of manipulation under anaesthesia of 0.5% is rather low. Nevertheless, we hypothesize that the course of the disease can be shortened with manipulation under anaesthesia, potentially leading to a quicker functional recovery and gain in range of motion compared to conservative treatment.

Objective: The current study aims to evaluate the difference in functional outcome, measured by the SPADI, and the duration of symptoms, after treatment of a frozen shoulder with or without manipulation under anaesthesia.

Study design: Randomized controlled trial Study population: Adult patients with clinical signs and symptoms of a frozen shoulder in phase 2 presenting to the outpatient clinic of the department of orthopaedic surgery of the participating hospital.

Intervention: Manipulation under anaesthesia

Main study parameters/endpoints: Primary outcome: Function, measured by the SPADI

Secondary outcomes: Function, measured by the oxford shoulder score (OSS). Pain at rest and during activity (Numeric Pain Rating Scale). General health related quality of life (EQ-5D),Range of motion (ROM), ability to work (Single item work ability Index, WORQ-UP in Dutch and Absenteeism past month. Usage of analgesics. Number of repeated corticosteroid infiltrations.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjective scores to fill out, and an increased number of(non-invasive) measurements of the function of the shoulder. Follow up consists of three moments at 1 month, 3 months and 1 year. The benefit of the study is to provide an answer to the question if manipulation under anaesthesia can indeed shorten the duration of symptoms and the advantages outweigh the possible disadvantages. There is a minimal combined risk of approximately 0.5% during the manipulation. possible complications of manipulation under anesthesia are: fracture, glenohumeral dislocation and brachial plexus traction injury. Another risk is an overtreatment of patients with a mild / relatively quick self-limiting natural course of the frozen shoulder.
- Main changes (audit trail)
- RECORD15-jan-2017 - 5-mrt-2017


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