Shoulder PainNCT06520254
The Effectiveness of Massage Therapy in Patients With Shoulder Pain
A study testing Massage therapy in people with Shoulder Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2019to 20 Mar 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 40 years,
- written consent to participate in the study,
- pain in the shoulder girdle area lasting at least 3 months,
- no medical contraindication of massage therapy;
Who cannot join
- Injuries, congenital defects in the chest area, cancer, deep vein thrombosis, heart attack in the last 5 years,
- Presence of inflammatory conditions in the respiratory, digestive, and genitourinary systems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Massage in Pain Reduction and Its Influence on the Range of Motion (ROM) of the Shoulder Complex in Patients With Shoulder Pain in Primary Care
The goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP.
The main questions it aims to answer are:
Read more
- Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
- Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
Researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain.
Participants in the massage group will:
Take part in 6 massage sessions (twice a week for 3 weeks) in the
Participants in the control group will:
Take part in 2 massage sessions (after the first and second assessment)
Read the detailed description
The aim of the study was to evaluate the effectiveness of massage therapy based on tensegrity principle in pain reduction and its influence on the range of motion of the shoulder complex in shoulder pain. .
Eesearch questions:
- Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
- Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
- Does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89
- What potential mechanisms may be induced by tensegrity massage in diseases of the shoulder complex?
Patients with symptoms of shoulder pain will be recruited for the study by general practitioners.
The following parameters related to the function of shoulder will be assessed:
- The active range of flexion, abduction and extension-adduction-rotation (hand behind back) of the upper limb were assessed.
- Pain sensations by the visual analogue scale-VAS
- The functional status of the shoulder complex by the UCLA scale (The University of California at Los Angeles Shoulder Score).
- Pain treshold by an algometer, the pressure
The study will rely on the palpation assessment and the massage methodology described in the recommendations of the Polish Society of Physiotherapy, Polish Society of Family Medicine and College of Family Physicians in Poland.
- Conditions
- Shoulder Pain
- Being tested
- Massage therapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
A 30-minute massage session will be applied in the following structures:
- Flexor hallucis longus muscle,
- Flexor digitorum longus muscle,
- Tibialis posterior muscle,
- Semitendinosus muscle,
- Semimembranosus muscle,
- Gluteus maximus muscle,
- Longissimus muscle,
- Levator costarum muscles 1-5 During the massage session basic Swedish massage techniques were used.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | Participants in the massage group will receive 6 massage sessions (twice a week for 3 weeks). Receives: Other: Massage therapy |
| Control group | No intervention | Participants in the control group will receive 2 massage sessions, first one at the baseline, second one after 3 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the pain threshold of the shoulder after therapy compared to baseline
Measuring device: The Wagner FPXTM Algometer produced by The Wagner Instruments, Greenwich CT, USA, Change = (Value after therapy - baseline)
Measured: 1) baseline, 2) 3 weeks after the first massage session massage session
Change in the The University of California at Los Angeles Shoulder Score after therapy compared to baseline
Measuring device: UCLA scale (The University of California at Los Angeles Shoulder Score) , Change = (Value after therapy - baseline)
Measured: 1) baseline, 2) 3 weeks after the first massage session massage session
Secondary outcomes (2)
Change in the Visual analog scale score after therapy compared to baseline
Measuring device: VAS scale - Visual analog scale - a continuous scale comprised of a horizontal line, 100 mm in length, anchored by "no pain" (score of 0) and "worst imaginable pain" score of 10, Change = (Value after therapy - baseline)
Measured: 1) baseline, 2) 3 weeks after the first massage session massage session
Change in ROM after therapy compared to baseline
Measuring device: a goniometr, Change = (Value after therapy - baseline)
Measured: 1) baseline, 2) 3 weeks after the first massage session massage session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Sep 2019
- Primary completion30 Jan 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- Model description
- a randomized, controlled, parallel, two-arm trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Kassolik, Phd, Wroclaw University of Health and Sport Sciences
- Investigators
- Anna Dobrzycka, Phd, Principal investigator, Idependent researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520254
- Sponsor's protocol ID
- Pain in shoulder
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artus M, Holt TA, Rees J. The painful shoulder: an update on assessment, treatment, and referral. Br J Gen Pract. 2014 Sep;64(626):e593-5. doi: 10.3399/bjgp14X681577. No abstract available.
PubMed 25179075Kassolik K, Jaskolska A, Kisiel-Sajewicz K, Marusiak J, Kawczynski A, Jaskolski A. Tensegrity principle in massage demonstrated by electro- and mechanomyography. J Bodyw Mov Ther. 2009 Apr;13(2):164-70. doi: 10.1016/j.jbmt.2007.11.002. Epub 2007 Dec 21.
PubMed 19329052
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Massage in Pain Reduction and Its Influence on the Range of Motion (ROM) of the Shoulder Complex in Patients With Shoulder Pain in Primary Care
- ClinicalTrials.gov ID
- NCT06520254
- Acronym / sponsor ID
- Pain in shoulder
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 25 Jul 2024 (actual)
- 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 goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP.
The main questions it aims to answer are:
- Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
- Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
Researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain.
Participants in the massage group will:
Take part in 6 massage sessions (twice a week for 3 weeks) in the
Participants in the control group will:
Take part in 2 massage sessions (after the first and second assessment)
Detailed description
The aim of the study was to evaluate the effectiveness of massage therapy based on tensegrity principle in pain reduction and its influence on the range of motion of the shoulder complex in shoulder pain. .
Eesearch questions:
- Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
- Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
- Does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89
- What potential mechanisms may be induced by tensegrity massage in diseases of the shoulder complex?
Patients with symptoms of shoulder pain will be recruited for the study by general practitioners.
The following parameters related to the function of shoulder will be assessed:
- The active range of flexion, abduction and extension-adduction-rotation (hand behind back) of the upper limb were assessed.
- Pain sensations by the visual analogue scale-VAS
- The functional status of the shoulder complex by the UCLA scale (The University of California at Los Angeles Shoulder Score).
- Pain treshold by an algometer, the pressure
The study will rely on the palpation assessment and the massage methodology described in the recommendations of the Polish Society of Physiotherapy, Polish Society of Family Medicine and College of Family Physicians in Poland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized, controlled, parallel, two-arm trial
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: Massage therapyParticipants in the massage group will receive 6 massage sessions (twice a week for 3 weeks). |
| Control group | No intervention | –Participants in the control group will receive 2 massage sessions, first one at the baseline, second one after 3 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 40 years,
- written consent to participate in the study,
- pain in the shoulder girdle area lasting at least 3 months,
- no medical contraindication of massage therapy;
Key exclusion criteria (2 listed)
- Injuries, congenital defects in the chest area, cancer, deep vein thrombosis, heart attack in the last 5 years,
- Presence of inflammatory conditions in the respiratory, digestive, and genitourinary systems
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 |
|---|---|---|
| Massage therapyA 30-minute massage session will be applied in the following structures: * Flexor hallucis longus muscle, * Flexor digitorum longus muscle, * Tibialis posterior muscle, * Semitendinosus muscle, * Semimembranosus muscle, * Gluteus maximus muscle, * Longissimus muscle, * Levator costarum muscles 1-5 During the massage session basic Swedish massage techniques were used. | Other | Massage group |
Primary outcome
Change in the pain threshold of the shoulder after therapy compared to baseline
Time frame: 1) baseline, 2) 3 weeks after the first massage session massage session
Measuring device: The Wagner FPXTM Algometer produced by The Wagner Instruments, Greenwich CT, USA, Change = (Value after therapy - baseline)
Change in the The University of California at Los Angeles Shoulder Score after therapy compared to baseline
Time frame: 1) baseline, 2) 3 weeks after the first massage session massage session
Measuring device: UCLA scale (The University of California at Los Angeles Shoulder Score) , Change = (Value after therapy - baseline)
2 secondary outcomes
Change in the Visual analog scale score after therapy compared to baseline
Time frame: 1) baseline, 2) 3 weeks after the first massage session massage session
Change in ROM after therapy compared to baseline
Time frame: 1) baseline, 2) 3 weeks after the first massage session massage session
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 29 Jul 2024.
- Results publication: PubMed 25179075Artus M, Holt TA, Rees J. The painful shoulder: an update on assessment, treatment, and referral. Br J Gen Pract. 2014 Sep;64(626):e593-5. doi: 10.3399/bjgp14X681577. No abstract available.
- Results publication: PubMed 19329052Kassolik K, Jaskolska A, Kisiel-Sajewicz K, Marusiak J, Kawczynski A, Jaskolski A. Tensegrity principle in massage demonstrated by electro- and mechanomyography. J Bodyw Mov Ther. 2009 Apr;13(2):164-70. doi: 10.1016/j.jbmt.2007.11.002. Epub 2007 Dec 21.
- Individual participant dataSharing planned: No
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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.
Anna Dobrzycka, Phd principal investigator
Idependent researcher
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 therapy in people with Shoulder 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 4 inclusion and 2 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 29 Jul 2024. 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?
Change in the pain threshold of the shoulder after therapy compared to baseline (time frame: 1) baseline, 2) 3 weeks after the first massage session massage session). The study lists 2 primary outcomes in all. 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 NCT06520254, which also lists 2 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 29 Jul 2024.