Shoulder PainNCT05080439
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
A study testing Diacutaneous Fibrolysis and Dry needling in people with Shoulder Pain and Dry Needling, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Shoulder Pain, Dry Needling, Diacutaneous Fibrolysis
- What is being tested?
- Diacutaneous Fibrolysis and Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2021to 31 Oct 2021
- 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Athletes with Shoulder pain
- Glenohumeral internal rotation deficit
- Presence of active MTrP in the teres major muscle
Who cannot join
- Previous surgery in the upper limb
- Previous physiotherapy treatments in the shoulder
- Dry needling contraindications
- Previous dry needling experience to mantain the blinding
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain.
- Being tested
- Diacutaneous Fibrolysis, Dry needling
- Medical subject headings
- Shoulder Pain, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacutaneous FibrolysisOther
Application of diacutaneous fibrolysis in teres major
Dry needlingOther
Dry needling based on fast-in fast-out technique in the teresa major muscle
| Study group | Role | What they receive |
|---|---|---|
| Diacutaneous Fibrolysis | Experimental | Diacutaneous Fibrolysis in the teres major muscle Receives: Other: Diacutaneous Fibrolysis |
| Dry needling | Experimental | Dry needling based on fast-in fast-out technique in the teres major muscle Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Measured: baseline
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Measured: After treatment immediately "1 hour"
muscle stiffness
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
Measured: After treatment, one week follow-up
Secondary outcomes (9)
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Measured: Baseline
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Measured: After treatment immediately "1 hour"
Pain intensity
the examiners assess the pain intensity using a visual analoigue scale
Measured: After treatment, "one week follow-up"
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Measured: Baseline
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Measured: After treatment immediately "1 hour"
Range of motion
the examiners assess the shoulder range of motion with an universal goniometer
Measured: After treatment, "one week follow-up"
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Measured: Baseline
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Measured: After treatment immediately "1 hour"
Extensibility
the examiners assess the extensibility of the posterior part of the tissues of the shoulder using a digital inclinometer
Measured: After treatment, "one week follow-up"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start10 Sep 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jiménez, University of Valladolid
- Investigators
- Luis Ceballos Laita, PhD, Study director, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080439
- Sponsor's protocol ID
- University of Valladolid.
- Status last verified
- Aug 2023
- First submitted
- 2 Sep 2021
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
- ClinicalTrials.gov ID
- NCT05080439
- Acronym / sponsor ID
- University of Valladolid.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Oct 2021 (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 aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diacutaneous Fibrolysis | Experimental | Other: Diacutaneous FibrolysisDiacutaneous Fibrolysis in the teres major muscle |
| Dry needling | Experimental | Other: Dry needlingDry needling based on fast-in fast-out technique in the teres major muscle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes with Shoulder pain
- Glenohumeral internal rotation deficit
- Presence of active MTrP in the teres major muscle
Key exclusion criteria (4 listed)
- Previous surgery in the upper limb
- Previous physiotherapy treatments in the shoulder
- Dry needling contraindications
- Previous dry needling experience to mantain the blinding
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 |
|---|---|---|
| Diacutaneous FibrolysisApplication of diacutaneous fibrolysis in teres major | Other | Diacutaneous Fibrolysis |
| Dry needlingDry needling based on fast-in fast-out technique in the teresa major muscle | Other | Dry needling |
Primary outcome
muscle stiffness
Time frame: baseline
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
muscle stiffness
Time frame: After treatment immediately "1 hour"
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
muscle stiffness
Time frame: After treatment, one week follow-up
the examiners assess the mechanical properties of the fascial and soft tissues with a myoton
9 secondary outcomes
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: After treatment immediately "1 hour"
Pain intensity
Time frame: After treatment, "one week follow-up"
Range of motion
Time frame: Baseline
Range of motion
Time frame: After treatment immediately "1 hour"
Range of motion
Time frame: After treatment, "one week follow-up"
Extensibility
Time frame: Baseline
Extensibility
Time frame: After treatment immediately "1 hour"
Extensibility
Time frame: After treatment, "one week follow-up"
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 Aug 2023.
- 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.
Luis Ceballos Laita, PhD study director
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous Fibrolysis and Dry needling in people with Shoulder Pain and Dry Needling, run by Universidad de Zaragoza 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 3 inclusion and 4 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 Aug 2023. 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?
muscle stiffness (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2023.