Shoulder PainGIRDTREATNCT05108311
Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain
A study testing Manual therapy and therapeutic exercise in people with Shoulder Pain and Glenohumeral Internal Rotation Deficit, run by CEU San Pablo University at 1 site in Spain.
Trial summary
Shoulder pain is one of the most common joint problems and disabling complaint in general population., but there is a lack of evidence about the relation between shoulder pain and glenohumeral internal rotation deficit (GIRD) in general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Glenohumeral Internal Rotation Deficit
- What is being tested?
- Manual therapy and therapeutic exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2021to 30 Jan 2022
- 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
- Shoulder pain
Who cannot join
- Patient under 18 years old,
- Pain in both shoulders
- Joint prosthesis in at least one of the two shoulders.
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder pain is one of the most common joint problems and disabling complaint in general population., but there is a lack of evidence about the relation between shoulder pain and glenohumeral internal rotation deficit (GIRD) in general population.
This study aimed to determine if the novel proposal for treatment of GIRD could be effectiveness and gain further evidence in the Range of Motion an Pain.
- Being tested
- Manual therapy and therapeutic exercise
- Keywords
- general population., Manual therapy, Therapeutic Exercise
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and therapeutic exerciseOther
- Gliding over the deltoid superficial fascia.
- Anterior-Posterior mobilization of the clavicle.
- myofascial release of the shoulder joint complex techniques.
- Myofascial release external rotation with glenohumeral decoaptation will be carry out in prone position facility the triangular space, quadrangular space and triceps hiatus.
- anterior and posterior, superior and inferior glenohumeral inferior glide mobilization in adduction will perform in a prone position to facilitate glenohumeral re centration.
- scapular musculature myofascial release including mobilization with a scapulothoracic joint decoaptation, and angular of the scapula.
- Supine mobilization of the posterior capsule in 90º shoulder flexion and the adduction.
Finally the patient will be instructed to adapt the daily active biological stimulus at home to maximize the benefits of the manual therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Treatment sequence including joint Manual therapy techniques and soft tissue release techniques is proposed. Receives: Other: Manual therapy and therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
glenohumeral internal rotation
measure in supine position on a physiotherapy bench. The shoulder will held at 90° abduction with 90° flexion in the elbow.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start22 Oct 2021
- Primary completion31 Dec 2021
- Study completion30 Jan 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Jácome López, PT, Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108311
- Sponsor's protocol ID
- CEU-024
- Acronym
- GIRDTREAT
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Protocol for Glenohumeral Internal Rotation Deficit in General Population With Shoulder Pain
- ClinicalTrials.gov ID
- NCT05108311
- Acronym / sponsor ID
- GIRDTREAT / CEU-024
- Keywords
- general population., Manual therapy, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 4 Nov 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.
Shoulder pain is one of the most common joint problems and disabling complaint in general population., but there is a lack of evidence about the relation between shoulder pain and glenohumeral internal rotation deficit (GIRD) in general population.
This study aimed to determine if the novel proposal for treatment of GIRD could be effectiveness and gain further evidence in the Range of Motion an Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Manual therapy and therapeutic exerciseThe Treatment sequence including joint Manual therapy techniques and soft tissue release techniques is proposed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shoulder pain
Key exclusion criteria (3 listed)
- Patient under 18 years old,
- Pain in both shoulders
- Joint prosthesis in at least one of the two shoulders.
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 |
|---|---|---|
| Manual therapy and therapeutic exercise1. Gliding over the deltoid superficial fascia. 2. Anterior-Posterior mobilization of the clavicle. 3. myofascial release of the shoulder joint complex techniques. 4. Myofascial release external rotation with glenohumeral decoaptation will be carry out in prone position facility the triangular space, quadrangular space and triceps hiatus. 5. anterior and posterior, superior and inferior glenohumeral inferior glide mobilization in adduction will perform in a prone position to facilitate glenohumeral re centration. 6. scapular musculature myofascial release including mobilization with a scapulothoracic joint decoaptation, and angular of the scapula. 7. Supine mobilization of the posterior capsule in 90º shoulder flexion and the adduction. Finally the patient will be instructed to adapt the daily active biological stimulus at home to maximize the benefits of the manual therapy | Other | Treatment |
Primary outcome
glenohumeral internal rotation
Time frame: Baseline
measure in supine position on a physiotherapy bench. The shoulder will held at 90° abduction with 90° flexion in the elbow.
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 14 Jul 2023.
- 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.
Rafael Jácome López, PT principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and therapeutic exercise in people with Shoulder Pain and Glenohumeral Internal Rotation Deficit, run by CEU San Pablo University 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 1 inclusion and 3 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 14 Jul 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?
glenohumeral internal rotation (time frame: Baseline). 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 14 Jul 2023.