Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis
Condition: Adhesive Capsulitis of the Shoulder
MeSH terms: Bursitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two treatments used for treating frozen shoulder
      which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to
      see if one relives pain and improves shoulder motion more quickly. The other purpose is to
      try and understand what causes frozen shoulder. For this purpose, tissue will be taken from
      the shoulder during surgery and studied for the presence and level of a protein called
      cytokine (Connective Tissue Growth Factor)
    

Detailed description: 
      Adhesive capsulitis of the shoulder is a relatively common entity which is poorly understood
      and produces a significant amount of morbidity in afflicted patients. The natural history of
      adhesive capsulitis is only just beginning to be understood. It is a self-limiting disease,
      but may take 18 to 36 months to resolve. During that time, individuals can suffer a
      significant amount of pain and miss a large amount of work. Many surgeons have treated this
      process with early manipulation with the outcome never being reported in a prospective
      manner. Some authors have advocated conservative non-operative treatment, knowing the natural
      history in most of these shoulders will be near resolution. The primary purpose of this study
      is to examine in a prospective randomized manner the results of continuous non-operative
      management versus arthroscopic capsulectomy. This study will determine if operative
      intervention with an arthroscopic capsulectomy can shorten the natural history of adhesive
      capsulitis, and give comparable results with non-operative management at final follow-up of 2
      years.

      A second purpose of the study is to try and identify the mechanism(s) responsible for
      adhesive capsulitis. Recent research suggests that cytokines and connective tissue growth
      factor (CTGF) may be involved in the inflammatory and fibrotic processes. The second purpose
      of this study involves histological and immunohistochemical analysis of capsular and synovial
      tissue routinely removed during an arthroscopic capsulectomy. Tissue taken from subjects in
      the surgical treatment group will be compared to tissue from patients undergoing an
      arthroscopic capsulectomy for reasons other than adhesive capsulitis (control group).
      Location and concentration of CTGF will be compared between these groups. If levels of CTGF
      are elevated in the treatment group as hypothesized, development and testing of agents that
      specifically reduce the action of CTGF may be indicated. A specific agent blocking CTGF has
      been developed and is nearing clinical trials.
    

Intervention name(s): Arthroscopy; Arthroscopic manipulation; Home therapy
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Randomized placement into 2 groups; arthroscopic manipulation or home therapy; Manipulation of shoulder performed during arthroscopy; Shoulder exercise program performed at home that may increase shoulder function
Other intervention name(s): No other names; No other names; No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment