Frozen ShoulderNCT00172601
Mobilization Techniques in Patients With Frozen Shoulder: a Randomized Multiple-Treatment Trial
A study testing mobilization in people with Frozen Shoulder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- mobilization
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School of Physical Therapy
Taipei
Jiu-jenq Lin, PhD, 23123456 ext. 7559, lxjst@ha.mc.ntu.edu.tw
About this study
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).
Read the 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.
- Conditions
- Frozen Shoulder
- Being tested
- mobilization
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilizationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jiu-jenq Lin, PhD, Principal investigator, School of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172601
- Sponsor's protocol ID
- 9361701198
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 24 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization Techniques in Patients With Frozen Shoulder: a Randomized Multiple-Treatment Trial
- ClinicalTrials.gov ID
- NCT00172601
- Acronym / sponsor ID
- 9361701198
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobilization | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2005.
Related trials for Frozen Shoulder
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Recruiting
Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
Adhesive Capsulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiu-jenq Lin, PhD principal investigator
School of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization in people with Frozen Shoulder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiu-jenq Lin, PhD (23123456-7559, lxjst@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2005.