Shoulder TendinopathyNCT06241404
Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points.
A study testing trigger point therapy and Exercise therapy in people with Shoulder Tendinopathy, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause. the most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Tendinopathy
- What is being tested?
- trigger point therapy and Exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 15 Jan 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Patients diagnosed by an orthopaedic surgeon with shoulder tendinopathy. tendinopathy.
- Symptoms of shoulder pain lasting more than 3 months.
- Pain on Jobe, Patte and infraspinatus assessment manoeuvres (highlighting abduction and abduction and external rotation).
Who cannot join
- Previous shoulder surgery.
- Radiating (non-referred) pain from cervical radiculopathy.
- Shoulder pain associated with other diagnoses (Examples: retractile capsulitis, subacromial syndrome, tendon rupture, posterosuperior conflict, etc.).
- subacromial syndrome, tendon rupture, posterosuperior conflict, etc).
- Patients with multiple pathologies.
- Patients with neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points in Shoulder Tendinopathies: Randomised Clinical Trial
Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause.
the most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact.
Read more
quality of life, leading to a major socio-economic impact. As a result, there are two treatment approaches with potential effectiveness: therapeutic exercise (TE) and myofascial trigger point treatment (TMT).
trigger point treatment (TTP).
Objective: The main objective of this randomised clinical trial is to determine the efficacy of ET versus treatment of MTPs in shoulder tendinopathies.
Methods: For this study, 20 participants were randomly divided into two groups: a ET group, with which a 10-exercise programme was initiated (n = 10), and a PGM group which was given an intervention protocol (n = 10).
intervention protocol (n = 10). Both received a total of 10 sessions. Pain intensity pain intensity, pressure pain threshold (PPT) and range of motion (ROM) were assessed before starting and after 10 sessions.
and after 10 sessions.
- Conditions
- Shoulder Tendinopathy
- Being tested
- trigger point therapy, Exercise therapy
- Keywords
- shoulder tendinopathy, supraspinatus, infraspinatus, physiotherapy techniques, therapeutic exercise, trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trigger point therapyProcedure or surgery
patients who have been treated for shoulder tendinopathy by trigger point therapy
Exercise therapyProcedure or surgery
patients who have been treated for shoulder tendinopathy by exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| therapeutic exercise group | Experimental | patients who have been treated for shoulder tendinopathy by exercise therapy Receives: Procedure: Exercise therapy |
| trigger points group | Active comparator | patients who have been treated for shoulder tendinopathy by trigger point therapy Receives: Procedure: trigger point therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
measurement of shoulder range of motion
Measured: At the end of Session 10 (each Session is 7 days)
pain intensity
measured on a VAS scale where 0 is the minimum and 10 is the maximum.
Measured: At the end of Session 10 (each Session is 7 days)
Secondary outcomes (1)
pressure pain threshold
measured by algometer
Measured: At the end of Session 10 (each Session is 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder TendinopathyStudies 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
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241404
- Sponsor's protocol ID
- 250124
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoma M, Herrington L, Mackenzie TA. The Effect of Exercise Therapy Interventions on Shoulder Pain and Musculoskeletal Risk Factors for Shoulder Pain in Competitive Swimmers: A Scoping Review. J Sport Rehabil. 2022 Feb 23;31(5):617-628. doi: 10.1123/jsr.2021-0403. Print 2022 Jul 1.
PubMed 35196648Jung KM, Choi JD. The Effects of Active Shoulder Exercise with a Sling Suspension System on Shoulder Subluxation, Proprioception, and Upper Extremity Function in Patients with Acute Stroke. Med Sci Monit. 2019 Jun 30;25:4849-4855. doi: 10.12659/MSM.915277.
PubMed 31256191Spanhove V, De Wandele I, Malfait F, Calders P, Cools A. Home-based exercise therapy for treating shoulder instability in patients with hypermobile Ehlers-Danlos syndrome/hypermobility spectrum disorders. A randomized trial. Disabil Rehabil. 2023 Jun;45(11):1811-1821. doi: 10.1080/09638288.2022.2076932. Epub 2022 May 24.
PubMed 35609204Richmond H, Lait C, Srikesavan C, Williamson E, Moser J, Newman M, Betteley L, Fordham B, Rees S, Lamb SE, Bruce J; PROSPER Study Group. Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER). BMC Health Serv Res. 2018 Jun 18;18(1):463. doi: 10.1186/s12913-018-3280-x.
PubMed 29914494Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.
PubMed 28714658Fathollahnejad K, Letafatkar A, Hadadnezhad M. The effect of manual therapy and stabilizing exercises on forward head and rounded shoulder postures: a six-week intervention with a one-month follow-up study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):86. doi: 10.1186/s12891-019-2438-y.
PubMed 30777064Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.
PubMed 28245853Villa Munoz T, Velazquez Saornil J, Sanchez Mila Z, Romero-Morales C, Almazan Polo J, Baraja Vegas L, Hugo-Villafane J, Abuin-Porras V. Comparative evaluation of the efficacy of therapeutic exercise versus myofascial trigger point therapy in the treatment of shoulder tendinopathies: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 16;10(4):e002043. doi: 10.1136/bmjsem-2024-002043. eCollection 2024.
PubMed 39430399
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points in Shoulder Tendinopathies: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06241404
- Acronym / sponsor ID
- 250124
- Conditions
- Shoulder Tendinopathy
- Keywords
- shoulder tendinopathy, supraspinatus, infraspinatus, physiotherapy techniques, therapeutic exercise, trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 5 Feb 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.
Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause.
the most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact.
quality of life, leading to a major socio-economic impact. As a result, there are two treatment approaches with potential effectiveness: therapeutic exercise (TE) and myofascial trigger point treatment (TMT).
trigger point treatment (TTP).
Objective: The main objective of this randomised clinical trial is to determine the efficacy of ET versus treatment of MTPs in shoulder tendinopathies.
Methods: For this study, 20 participants were randomly divided into two groups: a ET group, with which a 10-exercise programme was initiated (n = 10), and a PGM group which was given an intervention protocol (n = 10).
intervention protocol (n = 10). Both received a total of 10 sessions. Pain intensity pain intensity, pressure pain threshold (PPT) and range of motion (ROM) were assessed before starting and after 10 sessions.
and after 10 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic exercise group | Experimental | Procedure: Exercise therapypatients who have been treated for shoulder tendinopathy by exercise therapy |
| trigger points group | Active comparator | Procedure: trigger point therapypatients who have been treated for shoulder tendinopathy by trigger point therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form.
- Patients diagnosed by an orthopaedic surgeon with shoulder tendinopathy. tendinopathy.
- Symptoms of shoulder pain lasting more than 3 months.
- Pain on Jobe, Patte and infraspinatus assessment manoeuvres (highlighting abduction and abduction and external rotation).
Key exclusion criteria (6 listed)
- Previous shoulder surgery.
- Radiating (non-referred) pain from cervical radiculopathy.
- Shoulder pain associated with other diagnoses (Examples: retractile capsulitis, subacromial syndrome, tendon rupture, posterosuperior conflict, etc.).
- subacromial syndrome, tendon rupture, posterosuperior conflict, etc).
- Patients with multiple pathologies.
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 |
|---|---|---|
| trigger point therapypatients who have been treated for shoulder tendinopathy by trigger point therapy | Procedure or surgery | trigger points group |
| Exercise therapypatients who have been treated for shoulder tendinopathy by exercise therapy | Procedure or surgery | therapeutic exercise group |
Primary outcome
Range of motion
Time frame: At the end of Session 10 (each Session is 7 days)
measurement of shoulder range of motion
pain intensity
Time frame: At the end of Session 10 (each Session is 7 days)
measured on a VAS scale where 0 is the minimum and 10 is the maximum.
1 secondary outcome
pressure pain threshold
Time frame: At the end of Session 10 (each Session is 7 days)
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 Feb 2024.
- Background: PubMed 35196648Yoma M, Herrington L, Mackenzie TA. The Effect of Exercise Therapy Interventions on Shoulder Pain and Musculoskeletal Risk Factors for Shoulder Pain in Competitive Swimmers: A Scoping Review. J Sport Rehabil. 2022 Feb 23;31(5):617-628. doi: 10.1123/jsr.2021-0403. Print 2022 Jul 1.
- Background: PubMed 31256191Jung KM, Choi JD. The Effects of Active Shoulder Exercise with a Sling Suspension System on Shoulder Subluxation, Proprioception, and Upper Extremity Function in Patients with Acute Stroke. Med Sci Monit. 2019 Jun 30;25:4849-4855. doi: 10.12659/MSM.915277.
- Background: PubMed 35609204Spanhove V, De Wandele I, Malfait F, Calders P, Cools A. Home-based exercise therapy for treating shoulder instability in patients with hypermobile Ehlers-Danlos syndrome/hypermobility spectrum disorders. A randomized trial. Disabil Rehabil. 2023 Jun;45(11):1811-1821. doi: 10.1080/09638288.2022.2076932. Epub 2022 May 24.
- Background: PubMed 29914494Richmond H, Lait C, Srikesavan C, Williamson E, Moser J, Newman M, Betteley L, Fordham B, Rees S, Lamb SE, Bruce J; PROSPER Study Group. Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER). BMC Health Serv Res. 2018 Jun 18;18(1):463. doi: 10.1186/s12913-018-3280-x.
- Background: PubMed 28714658Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.
- Results publication: PubMed 30777064Fathollahnejad K, Letafatkar A, Hadadnezhad M. The effect of manual therapy and stabilizing exercises on forward head and rounded shoulder postures: a six-week intervention with a one-month follow-up study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):86. doi: 10.1186/s12891-019-2438-y.
- Results publication: PubMed 28245853Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.
- Derived from this study: PubMed 39430399Villa Munoz T, Velazquez Saornil J, Sanchez Mila Z, Romero-Morales C, Almazan Polo J, Baraja Vegas L, Hugo-Villafane J, Abuin-Porras V. Comparative evaluation of the efficacy of therapeutic exercise versus myofascial trigger point therapy in the treatment of shoulder tendinopathies: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 16;10(4):e002043. doi: 10.1136/bmjsem-2024-002043. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trigger point therapy and Exercise therapy in people with Shoulder Tendinopathy, run by Universidad Católica de Ávila at 1 site in Spain.
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 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 Feb 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 Spain. 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?
Range of motion (time frame: At the end of Session 10 (each Session is 7 days)). 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 NCT06241404, which also lists 8 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 5 Feb 2024.