Mobilization Techniques in Patients With Frozen Shoulder: a Randomized Multiple-Treatment Trial
Mobilization Techniques in Patients With Frozen Shoulder: a Randomized Multiple-Treatment Trial
Background: Frozen shoulder syndrome (FSS) or adhesive capsulitits, a condition of uncertain
 etiology characterized by a progressive loss of both active and passive shoulder motion, is
 one of the most common musculoskeletal disorders encountered in daily orthopaedic practice
 and remains challenging to treat. To regain the normal extensibility of shoulder capsule and
 tight muscular tissues, passive stretching of the shoulder capsule by means of mobilization
 techniques has been recommended, but limited data for supporting the use of these treatments
 are available. Due to the performance of techniques (mid-range/end-range mobilizations
 combined with or without interscalene brachial plexus block), a lack of objective and
 subjective outcome criteria, an inappropriate research design (case report and clinical trial
 without control), and utilization of other treatment modalities (home exercises and hot/cold
 packs), it is not possible to draw firm conclusions about the efficacy of mobilization in
 patients with FSS. Objective: The aim of our study is to investigate the effect of
 mobilization treatment and to determine whether a difference of treatment efficacy exists
 among three mobilization techniques (mid-range mobilization, end-range mobilization, and
 mobilization with movement) in patients with FSS. Design: We will carry out a crossover
 multiple-treatment trial on two groups. In group one, an A-B-A-C (A: mid-range mobilization,
 B: end-range mobilization, C: mobilization with movement) multiple-treatment design will be
 used. In group two, an A-C-A-B multiple-treatment design will be used. There will be three
 weeks of each phase. An independent trained outcome assessor, blinded to treatment
 allocation, will evaluate the participates at baseline and at 3-week intervals for 12 weeks.
 Outcome assessment include pain perception, disability assessment, and Shoulder complex
 kinematics and associated muscular activity. Analysis of covariance (ANCOVA) will be
 undertaken using the follow up data at 3, 6, 9 and 12 weeks for each of the outcomes, with
 adjustment for the baseline values of the outcome of interest. Independent t-Tests will be
 conducted to compare change of outcome variables between two groups (A-B in one group vs. A-C
 in the other group, A-C in one group vs. A-B in the other group).
We will carry out a multiple-treatment trial on two groups. The multiple-treatment trial
 involves the application of two or more treatments in one single-subject [Portney and
 Watkins, 2000; Barlow and Hersen, 1984]. It is used to compare the effects of two or more
 treatments. Consenting patients will be randomized by computer generated permuted block
 randomization of 5 to receive different mobilization treatments. Allocation concealment will
 be ensured and the study biostatistician will keep the assignment scheme. In group one, an
 A-B-A-C (A: mid-range mobilization, B: end-range mobilization, C: mobilization with movement)
 multiple-treatment design will be used. In group two, an A-C-A-B multiple-treatment design
 will be used. The two groups used here are intended to counterbalance the order effects of
 treatments. There will be three weeks of each phase. The differences in outcomes across the
 four phases of the study will be examined. An independent trained outcome assessor, blinded
 to treatment allocation, will evaluate the participates at baseline and at 3-week intervals
 for 12 weeks.
Inclusion Criteria:

 -  (1) having a painful stiff shoulder for at least 3 months, (2) having a limited ROM of
 a shoulder joint (ROM losses of 25% or greater compared with the noninvolved shoulder
 in at least 2 of the following shoulder motions: glenohumeral flexion, abduction, or
 medial/lateral rotation), and (3) the consent of the patient's physician to
 participate in the study.

 Exclusion Criteria:

 -  Additional specific exclusion criteria will be patients with (1) diabetes mellitus,
 (2) a history of surgery on the particular shoulder, (3) rheumatoid arthritis, (4) a
 painful stiff shoulder after a severe trauma, (5) fracture of the shoulder complex,
 (6) rotator cuff rupture, or (7) tendon calcification.