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

NCT00172601 | Unknown

• 1 other identifier: 9361701198
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

mobilization PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School of Physical Therapy

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jiu-jenq Lin, PhD

  School of Physical Therapy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiu-jenq Lin, PhD

CONTACT

23123456-7559; lxjst@ha.mc.ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Last Updated: November 24, 2005

Record last verified: 2004-12

Locations

TW (1)