Massage EffectPhase 1NCT01022827
Shoulder Muscle Massage Shoulder Stiffness
A Phase 1 study testing massage in people with Massage Effect, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Massage Effect
- What is being tested?
- massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Mar 2011
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a limited ROM of internal rotation (internal rotation ROM < 20% to the sound side), and
- pain and stiffness in the shoulder region for at least 3 months.
Who cannot join
- surgery on the particular shoulder,
- rheumatoid arthritis,
- stroke with residual shoulder involvement,
- fracture of the shoulder complex,
- rotator cuff deficiency, and
- resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Predictors of Effectiveness of Shoulder Muscle Massage for Patients With Posterior Shoulder Stiffness
The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded. Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive. The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression. The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P > 0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage. Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.
- Conditions
- Massage Effect
- Being tested
- massage
- Keywords
- stiff shoulder, massage, muscle stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
| Study group | Role | What they receive |
|---|---|---|
| posterior shoulder stiffness massage group | Experimental | The inclusion criteria of patients with glenohumeral internal rotation limitation and posterior shoulder stiffness were: [1] limitation of internal rotation ROM compared to the sound side; [2] mild glenohumeral joint hypomobility according to joint play assessment; [3] stiffness in the posterior shoulder region. Receives: Other: massage |
| posterior shoulder stiffness placebo group | Placebo comparator | Not described Receives: Other: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Measured: pre and post-massage
Secondary outcomes (2)
muscle stiffness
Measured: pre and post-massage
functional disability
Measured: pre and post-massage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionMar 2011
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 Massage EffectStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
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, School of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022827
- Sponsor's protocol ID
- 200905041R
- Status last verified
- Nov 2011
- First submitted
- 25 Nov 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang JL, Chen SY, Hsieh CL, Lin JJ. Effects and predictors of shoulder muscle massage for patients with posterior shoulder tightness. BMC Musculoskelet Disord. 2012 Mar 27;13:46. doi: 10.1186/1471-2474-13-46.
PubMed 22449170
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Predictors of Effectiveness of Shoulder Muscle Massage for Patients With Posterior Shoulder Stiffness
- ClinicalTrials.gov ID
- NCT01022827
- Acronym / sponsor ID
- 200905041R
- Conditions
- Massage Effect
- Keywords
- stiff shoulder, massage, muscle stiffness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Dec 2009 (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.
The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded. Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive. The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression. The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P > 0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage. Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior shoulder stiffness massage group | Experimental | Other: massageThe inclusion criteria of patients with glenohumeral internal rotation limitation and posterior shoulder stiffness were: [1] limitation of internal rotation ROM compared to the sound side; [2] mild glenohumeral joint hypomobility according to joint play assessment; [3] stiffness in the posterior shoulder region. |
| posterior shoulder stiffness placebo group | Placebo comparator | Other: massage |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a limited ROM of internal rotation (internal rotation ROM < 20% to the sound side), and
- pain and stiffness in the shoulder region for at least 3 months.
Key exclusion criteria (6 listed)
- surgery on the particular shoulder,
- rheumatoid arthritis,
- stroke with residual shoulder involvement,
- fracture of the shoulder complex,
- rotator cuff deficiency, and
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 |
|---|---|---|
| massageFor the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues | Other | posterior shoulder stiffness massage group, posterior shoulder stiffness placebo group |
Primary outcome
Range of Motion
Time frame: pre and post-massage
2 secondary outcomes
muscle stiffness
Time frame: pre and post-massage
functional disability
Time frame: pre and post-massage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Derived from this study: PubMed 22449170Yang JL, Chen SY, Hsieh CL, Lin JJ. Effects and predictors of shoulder muscle massage for patients with posterior shoulder tightness. BMC Musculoskelet Disord. 2012 Mar 27;13:46. doi: 10.1186/1471-2474-13-46.
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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
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 Phase 1 study testing massage in people with Massage Effect, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: pre and post-massage). 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 NCT01022827, 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 5 Jan 2012.