Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172601
Status:
UNKNOWN
Last Update Posted:
2005-11-24
First Post:
2005-09-12
Brief Title:
Mobilization Techniques in Patients With Frozen Shoulder a Randomized Multiple-Treatment Trial
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-rangeend-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 hotcold 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None