Shoulder Pain SyndromeNCT01307826
Massage in Treating Painful Shoulder
A study testing massage in people with Shoulder Pain Syndrome and Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The purpose of this study is to compare classical massage and massage based on the tensegrity rule in treating people with painful shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain Syndrome, Pain, Frozen Shoulder
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 sitePoland
- Study dates
- Jan 2008to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- painful shoulder syndrome
Who cannot join
- acute pain
- previous bones fracture
- bone relocations in the area of the shoulder girdle
- neck spondylosis
- hemiparesis
- rheumatoid arthritis
- any neurological symptoms
Trial locations and contacts
1 site in 1 country.
Poland1 site
University School of Physical Education in Wrocław
Wroclaw, Wroclaw Destrict, 51-612
About this study
Official title: Comparison of the Effectiveness of Massage Based on the Tensegrity Rule and Classical Massage in Treating Painful Shoulder
The purpose of this study is to compare classical massage and massage based on the tensegrity rule in treating people with painful shoulder.
Read the detailed description
The joint system of the shoulder girdle is exposed to frequent overloading, which can cause painful shoulder. The therapeutic methods applied in the treatment of painful shoulder syndrome include among others oral pharmacotherapy, joint injections, kinesitherapy, ultrasound, electrotherapy, laser. Manual therapy, chiropractic and surgery could also be used. Attempts have also been made to apply classical massage in treating painful shoulder, although it is not often used due to its low effectiveness.This study compares classical massage and massage based on the tensegrity rule which is not commonly known.
- Conditions
- Shoulder Pain Syndrome, Pain, Frozen Shoulder
- Being tested
- massage
- Keywords
- massage, shoulder, pain, range of motion, restricted range of motion
- Medical subject headings
- Pain, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
session - 20 minutes.
Before the massage, palpable evaluation of the selected anatomical structures was carried out - to determine which tissues have the greatest sensitivity and which motor organs show increased tension (by pressing the attachment). In all the examined patients, pain of the following muscle attachments were shown:
- latissimus muscle of the back
- major pectoral muscle
- supraspinous and infraspinous muscles
- teres minor muscle
- serratus anterior muscle
- deltoid muscle The decision which muscles and fascias have to be massaged was made on the basis of the performed evaluation. In most cases the above mentioned tissues (together with other motor system organs which are structurally linked to it) were massaged to relax them.
A palpable evaluation of the previously examined points was again performed during the final part, with particular attention paid to painful muscles, in order to analyze the effectiveness of the performed relaxation.
massageOther
classical massage (Swedish massage)
| Study group | Role | What they receive |
|---|---|---|
| tensegrity massage | Experimental | In this group of patients massage sessions based on the tensegrity method were applied. Receives: Other: massage |
| classical massage | Active comparator | In this group of patients 10 classical massage sessions were applied Receives: Other: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
mobility measurement
To assess massage effectiveness, mobility measurements were conducted in each patient. Both were conducted three times
Measured: immediately before the first massage session - Test 1, on the day the therapy ended - Test 2 - two weeks after therapy started, and one month after the last massage - Test 3
Secondary outcomes (1)
McGill Pain Questionnaire (SF-MPQ)
To assess massage effectiveness, McGill Pain Questionnaire (SF-MPQ) were conducted in each patient.
Measured: immediately before the first massage session - Test 1, on the day the therapy ended - Test 2 - two weeks after therapy started, and one month after the last massage - Test 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Shoulder Pain SyndromeStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Krzysztof Kassolik, PhD, Study chair, University School of Physical Education in Wrocław
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307826
- Sponsor's protocol ID
- 27022011KASS
- Status last verified
- Sep 2010
- First submitted
- 2 Mar 2011
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingber DE. Tensegrity and mechanotransduction. J Bodyw Mov Ther. 2008 Jul;12(3):198-200. doi: 10.1016/j.jbmt.2008.04.038. Epub 2008 Jun 16.
PubMed 19083675Yamada T, Richiert D, Tumminia SJ, Russell P. The tensegrity model applied to the lens: a hypothesis for the presence of the fiber cell ball and sockets. Med Hypotheses. 2000 Jul;55(1):36-9. doi: 10.1054/mehy.1999.0994.
PubMed 11021323Chen CS, Ingber DE; New Collective Author. Tensegrity and mechanoregulation: from skeleton to cytoskeleton. Osteoarthritis Cartilage. 1999 Jan;7(1):81-94. doi: 10.1053/joca.1998.0164.
PubMed 10367017Ingber DE; New Collective Author. Opposing views on tensegrity as a structural framework for understanding cell mechanics. J Appl Physiol (1985). 2000 Oct;89(4):1663-70. doi: 10.1152/jappl.2000.89.4.1663. No abstract available.
PubMed 11007610May S, Greasley A, Reeve S, Withers S. Expert therapists use specific clinical reasoning processes in the assessment and management of patients with shoulder pain: a qualitative study. Aust J Physiother. 2008;54(4):261-6. doi: 10.1016/s0004-9514(08)70005-9.
PubMed 19025506Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):231-6. doi: 10.1016/j.jse.2007.05.009. Epub 2007 Nov 12.
PubMed 17993282Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
PubMed 7559688Stevenson K. Evidence-based review of shoulder pain. Musculoskeletal Care. 2006 Dec;4(4):233-9. doi: 10.1002/msc.96. No abstract available.
PubMed 17117447Wies J, Treatment of eight patients with frozen shoulder: a case study series. Journal of Bodywork and Movement Therapies 9:58-64, 2004.
McMahon PJ, Sallis RE. The painful shoulder. Zeroing in on the most common causes. Postgrad Med. 1999 Dec;106(7):36-8, 41-3, 47-9. doi: 10.3810/pgm.1999.12.800.
PubMed 10608963Myers TW, Anatomy Trains, Myofascial Meridians for Manual and Movement Therapists. Churchill Livingstone: Edinburgh; 2009.
Brox JI. Regional musculoskeletal conditions: shoulder pain. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):33-56. doi: 10.1016/s1521-6942(02)00101-8.
PubMed 12659820Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.
PubMed 15756189Bunker TD, Frozen shoulder. Current Orthopaedics 12:193-201, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Massage Based on the Tensegrity Rule and Classical Massage in Treating Painful Shoulder
- ClinicalTrials.gov ID
- NCT01307826
- Acronym / sponsor ID
- 27022011KASS
- Conditions
- Shoulder Pain Syndrome, Pain, Frozen Shoulder
- Keywords
- massage, shoulder, pain, range of motion, restricted range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Mar 2011 (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 purpose of this study is to compare classical massage and massage based on the tensegrity rule in treating people with painful shoulder.
Detailed description
The joint system of the shoulder girdle is exposed to frequent overloading, which can cause painful shoulder. The therapeutic methods applied in the treatment of painful shoulder syndrome include among others oral pharmacotherapy, joint injections, kinesitherapy, ultrasound, electrotherapy, laser. Manual therapy, chiropractic and surgery could also be used. Attempts have also been made to apply classical massage in treating painful shoulder, although it is not often used due to its low effectiveness.This study compares classical massage and massage based on the tensegrity rule which is not commonly known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tensegrity massage | Experimental | Other: massageIn this group of patients massage sessions based on the tensegrity method were applied. |
| classical massage | Active comparator | Other: massageIn this group of patients 10 classical massage sessions were applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- painful shoulder syndrome
Key exclusion criteria (7 listed)
- acute pain
- previous bones fracture
- bone relocations in the area of the shoulder girdle
- neck spondylosis
- hemiparesis
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 |
|---|---|---|
| massagesession - 20 minutes. Before the massage, palpable evaluation of the selected anatomical structures was carried out - to determine which tissues have the greatest sensitivity and which motor organs show increased tension (by pressing the attachment). In all the examined patients, pain of the following muscle attachments were shown: * latissimus muscle of the back * major pectoral muscle * supraspinous and infraspinous muscles * teres minor muscle * serratus anterior muscle * deltoid muscle The decision which muscles and fascias have to be massaged was made on the basis of the performed evaluation. In most cases the above mentioned tissues (together with other motor system organs which are structurally linked to it) were massaged to relax them. A palpable evaluation of the previously examined points was again performed during the final part, with particular attention paid to painful muscles, in order to analyze the effectiveness of the performed relaxation. | Other | tensegrity massage |
| massageclassical massage (Swedish massage) | Other | classical massage |
Primary outcome
mobility measurement
Time frame: immediately before the first massage session - Test 1, on the day the therapy ended - Test 2 - two weeks after therapy started, and one month after the last massage - Test 3
To assess massage effectiveness, mobility measurements were conducted in each patient. Both were conducted three times
1 secondary outcome
McGill Pain Questionnaire (SF-MPQ)
Time frame: immediately before the first massage session - Test 1, on the day the therapy ended - Test 2 - two weeks after therapy started, and one month after the last massage - Test 3
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 3 Mar 2011.
- Background: PubMed 19083675Ingber DE. Tensegrity and mechanotransduction. J Bodyw Mov Ther. 2008 Jul;12(3):198-200. doi: 10.1016/j.jbmt.2008.04.038. Epub 2008 Jun 16.
- Background: PubMed 11021323Yamada T, Richiert D, Tumminia SJ, Russell P. The tensegrity model applied to the lens: a hypothesis for the presence of the fiber cell ball and sockets. Med Hypotheses. 2000 Jul;55(1):36-9. doi: 10.1054/mehy.1999.0994.
- Background: PubMed 10367017Chen CS, Ingber DE; New Collective Author. Tensegrity and mechanoregulation: from skeleton to cytoskeleton. Osteoarthritis Cartilage. 1999 Jan;7(1):81-94. doi: 10.1053/joca.1998.0164.
- Background: PubMed 11007610Ingber DE; New Collective Author. Opposing views on tensegrity as a structural framework for understanding cell mechanics. J Appl Physiol (1985). 2000 Oct;89(4):1663-70. doi: 10.1152/jappl.2000.89.4.1663. No abstract available.
- Background: PubMed 19025506May S, Greasley A, Reeve S, Withers S. Expert therapists use specific clinical reasoning processes in the assessment and management of patients with shoulder pain: a qualitative study. Aust J Physiother. 2008;54(4):261-6. doi: 10.1016/s0004-9514(08)70005-9.
- Background: PubMed 17993282Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):231-6. doi: 10.1016/j.jse.2007.05.009. Epub 2007 Nov 12.
- Background: PubMed 7559688Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
- Background: PubMed 17117447Stevenson K. Evidence-based review of shoulder pain. Musculoskeletal Care. 2006 Dec;4(4):233-9. doi: 10.1002/msc.96. No abstract available.
- BackgroundWies J, Treatment of eight patients with frozen shoulder: a case study series. Journal of Bodywork and Movement Therapies 9:58-64, 2004.
- Background: PubMed 10608963McMahon PJ, Sallis RE. The painful shoulder. Zeroing in on the most common causes. Postgrad Med. 1999 Dec;106(7):36-8, 41-3, 47-9. doi: 10.3810/pgm.1999.12.800.
- BackgroundMyers TW, Anatomy Trains, Myofascial Meridians for Manual and Movement Therapists. Churchill Livingstone: Edinburgh; 2009.
- Results publication: PubMed 12659820Brox JI. Regional musculoskeletal conditions: shoulder pain. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):33-56. doi: 10.1016/s1521-6942(02)00101-8.
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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.
Krzysztof Kassolik, PhD study chair
University School of Physical Education in Wrocław
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Shoulder Pain Syndrome and Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 7 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 3 Mar 2011. 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 Poland. 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?
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?
mobility measurement (time frame: immediately before the first massage session - Test 1, on the day the therapy ended - Test 2 - two weeks after therapy started, and one month after the last massage - Test 3). 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 NCT01307826, which also lists 14 linked publications.
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 3 Mar 2011.