The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
Condition: Frozen Shoulder; Hydrodilatation; Joint Mobilization; Corticosteroid Injection; Physical Therapy; Rehabilitation
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The effect of combination of hydrodilatation, corticosteroid injection, and joint
      mobilization for treatment of frozen shoulder, compared with general physical therapy.
    

Detailed description: 
      Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and
      active range of motion (ROM) of glenohumeral joint, and leads to disability, functional
      limitation, and decreasing quality of life. FS is usually treated with conservative
      treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation,
      intra-articular steroid injection, etc.. The short-term effect of each treatment is variable,
      and the long-term effect is not established. Clinically combination of each treatment is
      common, but types of combination, and the effect of combination is still not well studied. We
      aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and
      general physiotherapy to treat frozen shoulder and compare the long-term effect with general
      physical therapy alone.

      This is a prospective single-blind randomized controlled trial. 70 participants will be
      recruited from the outpatient clinic of the department of Physical Medicine and
      Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group
      and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided
      hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline)
      through both anterior and posterior shoulder joint in a two-weekly interval. In addition,
      joint mobilization and general physiotherapy (stretch exercise and physical modalities) will
      also be given, 2 times a week, for 8 weeks. The PT group will receive general physical
      therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and
      Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive
      range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36),
      and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months
      after the beginning of the treatment. Statistics will be performed after completing the
      patients' treatment and evaluations. We expect that the COMB group will recover sooner and
      better than the PT group.
    

Intervention name(s): Comb group; PT group
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.; The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: frozen shoulder; hydrodilatation; joint mobilization; corticosteroid injection; physical therapy; rehabilitation