Muscle StiffnessNCT01813396
Prediction of Functional Disability and Clinical Trial in Subjects With Stiff Shoulders
A study testing joint mobilization plus massage and joint mobilization/shoulder physical activity guide in people with Muscle Stiffness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
First, the purpose of the first year study will examine the joint capsule/muscular and shoulder physical activity hypotheses related to ROM deficits as well as functional disability in subjects with Stiff shoulders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Muscle Stiffness
- What is being tested?
- joint mobilization plus massage and joint mobilization/shoulder physical activity guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Mar 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- [1] a limited ROM of flexion, abduction, and rotation (ROM < 20% to the sound side); and [2] pain and stiffness in the shoulder region for at least 3 months.
Who cannot join
- surgery on the particular shoulder, [2] rheumatoid arthritis, [3] stroke with residual shoulder involvement, [4] fracture of the shoulder complex, [5] rotator cuff deficiency, and [6] resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital
Taipei
jiu-jenq Lin, phD, 886-2-33668126, jiujlin@ntu.edu.tw
jiu-jenq Lin, phD
About this study
Official title: Prediction of Functional Disability and Randomized Clinical Trial in Subjects With Stiff Shoulders: Joint Mobility, Range of Motion, Muscle Stiffness, and Shoulder Physical Activity
First, the purpose of the first year study will examine the joint capsule/muscular and shoulder physical activity hypotheses related to ROM deficits as well as functional disability in subjects with Stiff shoulders. Second, the purpose of the second and third year study will investigate the long-term effect of 12-week joint mobilization, 12-week joint mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft tissue mobilization/massage with appropriate shoulder physical activity guide on subjects with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be recruited. Second and third years: forty-five subjects with Stiff shoulders for one year follow-up. Methods: For the measurement outcomes; functional disability, rotation range of motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis, goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and accelerometers, respectively.
- Conditions
- Muscle Stiffness
- Being tested
- joint mobilization plus massage, joint mobilization/shoulder physical activity guide
- Keywords
- shoulder, muscle stiffness, shoulder physical activity, range of motion, joint mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint mobilization plus massageOther
joint mobilization/shoulder physical activity guideOther
| Study group | Role | What they receive |
|---|---|---|
| joint mobilization/massage | Experimental | joint mobilization: End-range joint mobilization
massage: massage twice a week on the identified muscle(s) of the involved shoulder about 6 minutes for each muscle for 3 months. The techniques of massage include petrissage for 3 minutes and rolling for 3 minutes of soft tissues Receives: Other: joint mobilization plus massage |
| joint mobilization/shoulder physical activity guide | Experimental | joint mobilization: End-range joint mobilization shoulder physical activity guide: shoulder physical activity guide is based on the appropriate cut off activity level identified in the predication rule Receives: Other: joint mobilization/shoulder physical activity guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder physical activity
analysis by RT3(shoulder activity measurement device)
Measured: right after 12-week treatment
Secondary outcomes (1)
Muscle stiffness
analysis by myotonometer(muscle stiffness measurement device)
Measured: right after 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startDec 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StiffnessStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jiu-jenq Lin, PhD, Principal investigator, Natinal Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813396
- Sponsor's protocol ID
- 201012075RB
- Status last verified
- Oct 2013
- First submitted
- 20 Feb 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang JL, Lin JJ, Huang HY, Huang TS, Chao YW. Shoulder physical activity, functional disability and task difficulties in patients with stiff shoulders: interpretation from RT3 accelerator. Man Ther. 2014 Aug;19(4):349-54. doi: 10.1016/j.math.2014.02.005. Epub 2014 Mar 5.
PubMed 24650638
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Functional Disability and Randomized Clinical Trial in Subjects With Stiff Shoulders: Joint Mobility, Range of Motion, Muscle Stiffness, and Shoulder Physical Activity
- ClinicalTrials.gov ID
- NCT01813396
- Acronym / sponsor ID
- 201012075RB
- Conditions
- Muscle Stiffness
- Keywords
- shoulder, muscle stiffness, shoulder physical activity, range of motion, joint mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 19 Mar 2013 (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.
First, the purpose of the first year study will examine the joint capsule/muscular and shoulder physical activity hypotheses related to ROM deficits as well as functional disability in subjects with Stiff shoulders. Second, the purpose of the second and third year study will investigate the long-term effect of 12-week joint mobilization, 12-week joint mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft tissue mobilization/massage with appropriate shoulder physical activity guide on subjects with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be recruited. Second and third years: forty-five subjects with Stiff shoulders for one year follow-up. Methods: For the measurement outcomes; functional disability, rotation range of motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis, goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and accelerometers, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| joint mobilization/massage | Experimental | Other: joint mobilization plus massagejoint mobilization: End-range joint mobilization massage: massage twice a week on the identified muscle(s) of the involved shoulder about 6 minutes for each muscle for 3 months. The techniques of massage include petrissage for 3 minutes and rolling for 3 minutes of soft tissues |
| joint mobilization/shoulder physical activity guide | Experimental | Other: joint mobilization/shoulder physical activity guidejoint mobilization: End-range joint mobilization shoulder physical activity guide: shoulder physical activity guide is based on the appropriate cut off activity level identified in the predication rule |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- [1] a limited ROM of flexion, abduction, and rotation (ROM < 20% to the sound side); and [2] pain and stiffness in the shoulder region for at least 3 months.
Key exclusion criteria (1 listed)
- surgery on the particular shoulder, [2] rheumatoid arthritis, [3] stroke with residual shoulder involvement, [4] fracture of the shoulder complex, [5] rotator cuff deficiency, and [6] resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
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 |
|---|---|---|
| joint mobilization plus massage | Other | joint mobilization/massage |
| joint mobilization/shoulder physical activity guide | Other | joint mobilization/shoulder physical activity guide |
Primary outcome
shoulder physical activity
Time frame: right after 12-week treatment
analysis by RT3(shoulder activity measurement device)
1 secondary outcome
Muscle stiffness
Time frame: right after 12-week treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Derived from this study: PubMed 24650638Yang JL, Lin JJ, Huang HY, Huang TS, Chao YW. Shoulder physical activity, functional disability and task difficulties in patients with stiff shoulders: interpretation from RT3 accelerator. Man Ther. 2014 Aug;19(4):349-54. doi: 10.1016/j.math.2014.02.005. Epub 2014 Mar 5.
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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
Natinal Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint mobilization plus massage and joint mobilization/shoulder physical activity guide in people with Muscle Stiffness, 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 1 Nov 2013. 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 (+886+2+33668126, jiujlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder physical activity (time frame: right after 12-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01813396, which also lists 1 linked publication.
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 1 Nov 2013.