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

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.

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.

1, 3 months and 1 year

Manipulation under anesthesia +

Physiotherapy