Manipulation under anesthesia versus physiotherapy treatment in stage two of a frozen shoulder: a study protocol for a randomized controlled trial

Abstract

BackgroundThere is no consensus about the optimal treatment strategy for frozen shoulders (FS). Conservative treatment consisting of intra-articular corticosteroid infiltrations and physiotherapy are considered appropriate for most patients. However, with a conservative strategy, patients experience a prolonged rehabilitation period with a considerable amount of pain and disabilities in daily life. Also, at long term, a residual amount of pain and restriction of range of motion is frequently reported. Manipulation under anesthesia is a short and relative simple procedure with the potential to rapidly reduce symptoms and restore the range of motion. The objective of this trial is to evaluate the effectiveness of MUA followed by a PT program compared to a PT program alone, in the treatment of patients with a stage two FS. We hypothesize that the course of the disease can be shortened with MUA with a quicker functional recovery.MethodsThis is a prospective, single center, randomized controlled trial. Eligible patients will be allocated to either the manipulation (MUA) group or the physiotherapy alone (PT) group. In the MUA group manipulation will be performed under interscalene block, directly followed by an intensive physiotherapy treatment protocol, with the goal to maintain the obtained range of motion. Patients allocated to the PT group are given advice and education and receive a written protocol to hand out to their physical therapist based on the recent guideline of the Dutch Shoulder Network for the treatment of frozen shoulders. Descriptive statistics will be used to describe the sample size, patients demographics, presence of diabetes mellitus, range of motion, duration of symptoms till randomization and will be presented for each treatment group. The SPADI is used as primary functional outcome parameter. Secondary outcome parameters are; OSS, NPRS, EQ-5D 3-L, passive range of motion, WORQ-UP, duration of symptoms, usage of analgesics and adverse events. A sample size of 41 subjects in each group was calculated. Follow up is planned after 1,3 and 12 months. The length of physiotherapy treatment in both groups is variable, depending on individual progression. Differences between groups in outcome parameters will be analysed using the linear mixed modelling and the restricted maximum likelihood ratio technique for estimating the model parameters.DiscussionSuccessful completion of this trial will provide evidence on the best treatment strategy for patients with a stage two frozen shoulder. The results of this study can lead to a better understanding for the role of manipulation in the treatment of frozen shoulders.Trial registrationThis trial is registered in the Dutch Trial Register under the number NTR6182 on the 20th of February 2017.

Can manipulation under anesthesia alone provide clinical outcomes similar to arthroscopic circumferential capsular release in primary frozen shoulder (FS)?: the necessity of arthroscopic capsular release in primary FS

“…Recent developments in ultrasound technology have enabled its use with brachial plexus anesthesia or cervical root block [13][14][15][16]29]. Previous reports described good results like those of the present study in primary FS patients with or without diabetes.…”

“…Woods and Loganathan [30] found that patients with successful outcomes have significant improvement in pain within three to four days after MUA, and improvement in ROM within about three weeks. Kraal et al [29] also found that an initial period of one to 2 weeks of intensive physiotherapy after MUA is essential to prevent recurrence of restrictions and advocated more aggressive rehabilitation with intensive stretching and ROM exercises in the first weeks after MUA to preserve the obtained ROM. The importance of early rehabilitation is the same in ACR and MUA in terms of surgical treatment for joint stiffness [20].…”

The Effectiveness of Physiotherapy in Idiopathic or Primary Frozen Shoulder: a Systematic Review and Meta-Analysis

“…Frozen shoulder is a condition characterized by spontaneous onset of pain, ROM restriction, stiffness and limitation of glenohumeral joint (1)(2)(3)(4)(5). Also defined adhesive capsulitis, it is an unknown etiology disorder (primary or idiopathic frozen shoulder); when it is associated with traumas or systemic diseases, such as diabetes mellitus II type, thyroid diseases, rheumatoid arthritis etc., it is defined secondary frozen shoulder.…”

“…Another theory tells that if the immobilization due to injury and pain is kept up longer than necessary, it may lead to learned non-use, loss of cortical representation and then stiffness and pain (11). Early diagnosis is not easy: the first symptom is the onset of a nocturnal and daily pain causing restriction in function and daily activities (1)(2)(3)5); there is a loss of both passive and active movements, particularly a loss of more than 30° in passive external rotation (2); there is weakness of supraspinatus muscle and long head biceps lack of flexibility which cause limitation in abduction (12)(13)(14). In this pathologic mechanism the capsule does not become adhered to the humerus, but the contracted capsule holds the humeral head tightly against the glenoid fossa, causing a progressive loss of the physiological movements (15).…”

“…Based on this and on the absence of a significant correlation between joint space capacity and restricted ROM, some authors reported that tightness of capsule and soft tissues around bring to a proportional motion restriction, more in external rotation than internal rotation (38). Many authors divide the natural course of the disease in three stages (1)(2)(3)6,12,13,16,17): stage I (freezing or painful stage) of 3-9 months, characterized by pain and progressive reduction of function and joint mobility; stage II (frozen stage) of 4-12 months which may not lead to increased pain but to a strong limitation of movements and ROM particularly external rotation, frontal flexion and abduction; stage III (thawing stage) of 12-42 months characterized by a progressive rise and recovery of movements and ROM. Other authors (18) reported four stages based on the arthroscopic course.…”