Subacromial ImpingementNCT03568006
Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome
A study testing Specific passive mobilization and Standardized treatment (standard protocol) in people with Subacromial Impingement, run by Universidad San Jorge at 1 site in Spain.
Trial summary
From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Subacromial Impingement
- What is being tested?
- Specific passive mobilization and Standardized treatment (standard protocol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 17 Sep 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of subacromial syndrome
- Pain at rest, which increases when doing active movements
- Neer´s impingement test positive
- Hawkins Kennedy test positive
- Pain lasting more than one month
- Anteriorization of humeral head
- Full capacity (physical and cognitive) to participate in the study and give consent.
Who cannot join
- Infiltrations during the previous six months
- Traumatic origin of pain
- Complete tear of any rotator cuff tendon
- Bilateral pain
- Previous surgical intervention in the affected shoulder
- Patients planning to start with other treatments during the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial
From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.
The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome.
Read the detailed description
Subacromial syndrome, also known as subacromial impingement, is the most frequent disorder in the shoulder joint. It has a multifactorial origin and represents a wide spectrum of pathologies. Its main consequences are pain and loss of function in the glenohumeral joint. From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.
The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome. To this end, a randomized clinical trial will be carried out in the Montpellier Clinic in Zaragoza. Twenty-two patients will be recruited and randomly assigned to one of the two groups (intervention and control). Both groups will receive a standardized treatment consisting of: 10 sessions of infrared rays, and a program of therapeutic exercises and indications to improve their postural hygiene. In addition, the intervention group will receive a passive joint mobilization in the glenohumeral joint of 5 minutes. Pain intensity, range of motion and functionality of the glenohumeral joint will be measured in the first session before any treatment and in the tenth session after the treatment.
- Conditions
- Subacromial Impingement
- Being tested
- Specific passive mobilization, Standardized treatment (standard protocol)
- Keywords
- subacromial impingement, pain, shoulder, passive mobilization
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific passive mobilizationOther
Specific passive mobilizations for the shoulder
Standardized treatment (standard protocol)Other
Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint.
Besides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene. Receives: Other: Specific passive mobilization; Other: Standardized treatment (standard protocol) |
| Control | Active comparator | Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene. Receives: Other: Standardized treatment (standard protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain
Measured: Change between baseline (immediately before intervention) and post intervention (2 weeks).
Secondary outcomes (2)
Active range of motion
Measurement of active range of motion for the different shoulder movements (abduction from 0 to 150º, flexion from 0 to 180º, extension from 0 to 60º, lateral rotation from 0 to 90º, internal rotation from o to 70º)
Measured: Change between baseline (immediately before intervention) and post intervention (2 weeks).
Constant Score
Scale to measure shoulder function, ranging from 0 to 100. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: Change between baseline (immediately before intervention) and post intervention (2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial ImpingementStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Montpellier Clinic
- Responsible party
- Principal investigator, Pablo Herrero Gallego, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568006
- Sponsor's protocol ID
- TM_AJ
- Status last verified
- Sep 2018
- First submitted
- 12 Jun 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03568006
- Acronym / sponsor ID
- TM_AJ
- Conditions
- Subacromial Impingement
- Keywords
- subacromial impingement, pain, shoulder, passive mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Montpellier Clinic
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 26 Jun 2018 (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.
From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.
The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome.
Detailed description
Subacromial syndrome, also known as subacromial impingement, is the most frequent disorder in the shoulder joint. It has a multifactorial origin and represents a wide spectrum of pathologies. Its main consequences are pain and loss of function in the glenohumeral joint. From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.
The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome. To this end, a randomized clinical trial will be carried out in the Montpellier Clinic in Zaragoza. Twenty-two patients will be recruited and randomly assigned to one of the two groups (intervention and control). Both groups will receive a standardized treatment consisting of: 10 sessions of infrared rays, and a program of therapeutic exercises and indications to improve their postural hygiene. In addition, the intervention group will receive a passive joint mobilization in the glenohumeral joint of 5 minutes. Pain intensity, range of motion and functionality of the glenohumeral joint will be measured in the first session before any treatment and in the tenth session after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Specific passive mobilization, Other: Standardized treatment (standard protocol)Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint. Besides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene. |
| Control | Active comparator | Other: Standardized treatment (standard protocol)Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of subacromial syndrome
- Pain at rest, which increases when doing active movements
- Neer´s impingement test positive
- Hawkins Kennedy test positive
- Pain lasting more than one month
Key exclusion criteria (6 listed)
- Infiltrations during the previous six months
- Traumatic origin of pain
- Complete tear of any rotator cuff tendon
- Bilateral pain
- Previous surgical intervention in the affected shoulder
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 |
|---|---|---|
| Specific passive mobilizationSpecific passive mobilizations for the shoulder | Other | Intervention |
| Standardized treatment (standard protocol)Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene | Other | Control, Intervention |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).
10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain
2 secondary outcomes
Active range of motion
Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).
Constant Score
Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).
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 19 Sep 2018.
- 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.
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 Specific passive mobilization and Standardized treatment (standard protocol) in people with Subacromial Impingement, run by Universidad San Jorge 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 7 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 19 Sep 2018. 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?
Visual Analogue Scale (VAS) (time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).). 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 19 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.