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Mobilization Techniques in Patients With Frozen Shoulder: a Randomized Multiple-Treatment Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172601
First received: September 12, 2005
Last updated: November 23, 2005
Last verified: December 2004
  Purpose

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).


Condition Intervention
Frozen Shoulder
Procedure: mobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Pain perception
  • Disability assessment by self-reports:
  • Flexilevel Scale of Shoulder Function (FLEX-SF)
  • DASH (Disabilities of the Arm, Shoulder and Hand)
  • Short form 36 item health survey (SF-36)
  • Shoulder complex kinematics and associated muscular activity

Estimated Enrollment: 30
Study Start Date: August 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172601

Contacts
Contact: Jiu-jenq Lin, PhD 23123456-7559 lxjst@ha.mc.ntu.edu.tw

Locations
Taiwan
School of Physical Therapy Recruiting
Taipei, Taiwan
Contact: Jiu-jenq Lin, PhD    23123456 ext 7559    lxjst@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jiu-jenq Lin, PhD School of Physical Therapy, National Taiwan University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00172601     History of Changes
Other Study ID Numbers: 9361701198
Study First Received: September 12, 2005
Last Updated: November 23, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014