No registrations found.
ID
Source
Brief title
Health condition
Frozen shoulder, adhesive capsulitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
SPADI
Secondary outcome
OSS, NRS, EQ 5D, ROM, WORQ-UP
Background summary
Rationale: 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.
Study objective
We 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.
Study design
1, 3 months and 1 year
Intervention
Manipulation under anesthesia +
Physiotherapy
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6043 |
| NTR-old | NTR6182 |
| CCMO | NL.56143.101.16 |