Subacromial Impingement SyndromeNCT04073199
Comparison of Two Stretching Techniques in Patients Suffering From Subacromial Syndrome
A study testing Long Lever Group and Short Lever Group in people with Subacromial Impingement Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The shoulder stability has always been related to the rotator cuff complex, although more and more is contemplated the Teres Major muscle and its affectation in the shape of the trigger points within this pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Long Lever Group and Short Lever Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2017to 20 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years.
- Present clinical diagnosis of Subacromial Impingement Syndrome
- Threshold of pain in the Teres Major muscle pressure less than 2 Kg / cm2.
- Signature of informed consent.
Who cannot join
- Pre-shoulder surgery (<1 year).
- Inability to keep supine position.
- Contraindications for stretching: (collagen / tissue diseases connective: Ehlers-Danlos, Morquio, Grisel), scars in the healing process or pathological in the area like keloids, acute inflammatory process on the shoulder (<7 days), severe limitation of the range of movement towards flexion (<90º passive).
- Infiltrations (the last 3 months) or during treatment.
- Be pending litigation or legal claim.
- Cognitive problems or idiomatic barrier.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre de Rehabilitació en Atenció Primària (Institut Català de la Salut)
Cornellà de Llobregat, Barcelona, 08940
About this study
Official title: Effectiveness of the Stretching of the Teres Major in Patients Suffering From Subacromial Syndrome
The shoulder stability has always been related to the rotator cuff complex, although more and more is contemplated the Teres Major muscle and its affectation in the shape of the trigger points within this pathology. As non-invasive measures for the deactivation of these myofascial points, Travell and Simons recommended the pressure maintained along with muscular stretch.
Stretching are usually a technique widely used in our practice as physiotherapists and it is necessary to study its effects in the clinic. As an objective we plan to compare the effect of passive stretching in short lever according to the Orthopaedic Manual Therapy concept if it produces better result in the pain, the rank of movement and in the Function, with the effect of stretching by means of a long lever in affected patients of subacromial syndrome.
Read more
This is a randomized controlled study with blind evaluator approved by the Ethical Committee of the Institut d'Investigació en atenció Primaria Jordi Gol.
After checking the inclusion and exclusion criteria, you will be asked, voluntarily, that the patient sign informed consent. The variables will then be valued independent and dependent on the study. It will randomly be assigned to one of the three groups in the study. The 3 groups receive the protocolized treatment for the service they consist of In superficial thermotherapy, an educational talk and kinesitherapy. The intervention groups will receive alternate days, with a total of six sessions, the stretch corresponding to the group to which they have been assigned.
In the case of the Long Lever Group, the intervention consists in a rotary stretch through the humerus as a mobile point. And in the case of the Short Lever Group a stretch of translocation through the scapula as a mobile point.
The main variables used will be: age, side effects, habits involving the shoulder, pain intensity, pain threshold at pressure and function, among others. The dependent variables will be measured: pain intensity by means of Analogue Scale Visual, the function through the Constant-Murley test, the Movement Range with Goniometer and the Pressure Threshold Pain with a pressure gauge brand Stech.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Long Lever Group, Short Lever Group
- Keywords
- stretching,teres major, subacromial syndrome, manual therapy
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Lever GroupProcedure or surgery
the physiotherapist wears the limb passively towards flexion, external rotation and abduction until the physiotherapist has perception of stretch of the tissues (sensation terminal elastic firm according to the concept of Orthopaedic Manual Therapy for the soft tissue treatment) The patient's own weight stabilizes the proximal segment, in case that the scapula is not stable, the physiotherapist fixes with his free hand the scapula.
The technique will be performed two days a week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate).
Short Lever GroupProcedure or surgery
It consists of a stretch made by the physiotherapist, with the patient in supine position, with the extremity to be treated in a submaximal position of flexion and external rotation (fixed by the arm and body of the physiotherapist) and realizing the stretch a through the scapula in the medial and caudal dorsal direction.
The technique will be performed two days per week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate)
| Study group | Role | What they receive |
|---|---|---|
| Long Lever Group | Active comparator | This arm receive the protocolized treatment along with the long passive stretch of the Teres Major in Long Lever with the patient in supine position. Receives: Procedure: Long Lever Group |
| Short Lever Group | Active comparator | This arm receive the protocolized treatment along with the short lever stretch according to the Orthopaedic Manual Therapy of the Teres Major. Receives: Procedure: Short Lever Group |
| Control Group | No intervention | only receive the protocolized physiotherapy treatment for the Subacromial syndrome that is applied in the Rehabilitation Service, without the addition of any additional stretch technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
It will be measured using an Analog Visual Scale. The scale to be used, always the same in each measurement.
Measured: 2 minutes needed for the explanation and the realization of the measure.
Threshold Pressure Pain
The patient will be placed in a chair with a table in front, where can support the elbow and forearm in shape comfortable. The physiotherapist takes a clamp without pushing the Teres Major muscle and will perform progressive pressure with the algometer until the patient refers pain sensation.
The subjects who perceive pain with a threshold of pressure below 2kg / cm2 will be included in the study according to Andersen et al
Measured: 5 minutes needed for explain the technique and realise it.
Active Mobility
The measurement of active mobility (active flexion, active extension, active abduction, active external rotation, active internal rotation) will be done in standing position with the back supported in the framework of a door (to unify positions and allow us to carry out the extension) with a goniometer for flexion, extension, abduction and external rotation, and with a tape metric for internal rotation (measurement from the thumb to the spinous process of C7)
Measured: 10 minutes needed for explain the movements required and make de measurements.
Function
The assessment of the function will be performed through the constant Constant-Murley test.
The Constant-Murley test abbreviated is a scale that measures the function of the shoulder on the basis of three components: pain, mobility and activities of daily life, resulting in a value maximum of 75 points, in the case that there is no limitation.
Measured: 10 minutes needed for the realization of the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start20 Mar 2017
- Primary completion20 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gemma G Nin, Ms, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073199
- Sponsor's protocol ID
- P17/072
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data can be shared once the study has finished and its subsequent publication with anyone who requires it formally in writing to the Main Investigator
Publications
van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.
PubMed 10952865Page MJ, Green S, Mrocki MA, Surace SJ, Deitch J, McBain B, Lyttle N, Buchbinder R. Electrotherapy modalities for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012225. doi: 10.1002/14651858.CD012225.
PubMed 27283591Yu H, Cote P, Shearer HM, Wong JJ, Sutton DA, Randhawa KA, Varatharajan S, Southerst D, Mior SA, Ameis A, Stupar M, Nordin M, van der Velde GM, Carroll L, Jacobs CL, Taylor-Vaisey AL, Abdulla S, Shergill Y. Effectiveness of passive physical modalities for shoulder pain: systematic review by the Ontario protocol for traffic injury management collaboration. Phys Ther. 2015 Mar;95(3):306-18. doi: 10.2522/ptj.20140361. Epub 2014 Nov 13.
PubMed 25394425van den Dolder PA, Roberts DL. A trial into the effectiveness of soft tissue massage in the treatment of shoulder pain. Aust J Physiother. 2003;49(3):183-8. doi: 10.1016/s0004-9514(14)60238-5.
PubMed 12952518Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Stretching of the Teres Major in Patients Suffering From Subacromial Syndrome
- ClinicalTrials.gov ID
- NCT04073199
- Acronym / sponsor ID
- P17/072
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- stretching,teres major, subacromial syndrome, manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 29 Aug 2019 (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 shoulder stability has always been related to the rotator cuff complex, although more and more is contemplated the Teres Major muscle and its affectation in the shape of the trigger points within this pathology. As non-invasive measures for the deactivation of these myofascial points, Travell and Simons recommended the pressure maintained along with muscular stretch.
Stretching are usually a technique widely used in our practice as physiotherapists and it is necessary to study its effects in the clinic. As an objective we plan to compare the effect of passive stretching in short lever according to the Orthopaedic Manual Therapy concept if it produces better result in the pain, the rank of movement and in the Function, with the effect of stretching by means of a long lever in affected patients of subacromial syndrome.
This is a randomized controlled study with blind evaluator approved by the Ethical Committee of the Institut d'Investigació en atenció Primaria Jordi Gol.
After checking the inclusion and exclusion criteria, you will be asked, voluntarily, that the patient sign informed consent. The variables will then be valued independent and dependent on the study. It will randomly be assigned to one of the three groups in the study. The 3 groups receive the protocolized treatment for the service they consist of In superficial thermotherapy, an educational talk and kinesitherapy. The intervention groups will receive alternate days, with a total of six sessions, the stretch corresponding to the group to which they have been assigned.
In the case of the Long Lever Group, the intervention consists in a rotary stretch through the humerus as a mobile point. And in the case of the Short Lever Group a stretch of translocation through the scapula as a mobile point.
The main variables used will be: age, side effects, habits involving the shoulder, pain intensity, pain threshold at pressure and function, among others. The dependent variables will be measured: pain intensity by means of Analogue Scale Visual, the function through the Constant-Murley test, the Movement Range with Goniometer and the Pressure Threshold Pain with a pressure gauge brand Stech.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long Lever Group | Active comparator | Procedure: Long Lever GroupThis arm receive the protocolized treatment along with the long passive stretch of the Teres Major in Long Lever with the patient in supine position. |
| Short Lever Group | Active comparator | Procedure: Short Lever GroupThis arm receive the protocolized treatment along with the short lever stretch according to the Orthopaedic Manual Therapy of the Teres Major. |
| Control Group | No intervention | –only receive the protocolized physiotherapy treatment for the Subacromial syndrome that is applied in the Rehabilitation Service, without the addition of any additional stretch technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 18 years.
- Present clinical diagnosis of Subacromial Impingement Syndrome
- Threshold of pain in the Teres Major muscle pressure less than 2 Kg / cm2.
- Signature of informed consent.
Key exclusion criteria (6 listed)
- Pre-shoulder surgery (<1 year).
- Inability to keep supine position.
- Contraindications for stretching: (collagen / tissue diseases connective: Ehlers-Danlos, Morquio, Grisel), scars in the healing process or pathological in the area like keloids, acute inflammatory process on the shoulder (<7 days), severe limitation of the range of movement towards flexion (<90º passive).
- Infiltrations (the last 3 months) or during treatment.
- Be pending litigation or legal claim.
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 |
|---|---|---|
| Long Lever Groupthe physiotherapist wears the limb passively towards flexion, external rotation and abduction until the physiotherapist has perception of stretch of the tissues (sensation terminal elastic firm according to the concept of Orthopaedic Manual Therapy for the soft tissue treatment) The patient's own weight stabilizes the proximal segment, in case that the scapula is not stable, the physiotherapist fixes with his free hand the scapula. The technique will be performed two days a week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate). | Procedure or surgery | Long Lever Group |
| Short Lever GroupIt consists of a stretch made by the physiotherapist, with the patient in supine position, with the extremity to be treated in a submaximal position of flexion and external rotation (fixed by the arm and body of the physiotherapist) and realizing the stretch a through the scapula in the medial and caudal dorsal direction. The technique will be performed two days per week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate) | Procedure or surgery | Short Lever Group |
Primary outcome
Pain Intensity
Time frame: 2 minutes needed for the explanation and the realization of the measure.
It will be measured using an Analog Visual Scale. The scale to be used, always the same in each measurement.
Threshold Pressure Pain
Time frame: 5 minutes needed for explain the technique and realise it.
The patient will be placed in a chair with a table in front, where can support the elbow and forearm in shape comfortable. The physiotherapist takes a clamp without pushing the Teres Major muscle and will perform progressive pressure with the algometer until the patient refers pain sensation. The subjects who perceive pain with a threshold of pressure below 2kg / cm2 will be included in the study according to Andersen et al
Active Mobility
Time frame: 10 minutes needed for explain the movements required and make de measurements.
The measurement of active mobility (active flexion, active extension, active abduction, active external rotation, active internal rotation) will be done in standing position with the back supported in the framework of a door (to unify positions and allow us to carry out the extension) with a goniometer for flexion, extension, abduction and external rotation, and with a tape metric for internal rotation (measurement from the thumb to the spinous process of C7)
Function
Time frame: 10 minutes needed for the realization of the test
The assessment of the function will be performed through the constant Constant-Murley test. The Constant-Murley test abbreviated is a scale that measures the function of the shoulder on the basis of three components: pain, mobility and activities of daily life, resulting in a value maximum of 75 points, in the case that there is no limitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Background: PubMed 10952865van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.
- Background: PubMed 27283591Page MJ, Green S, Mrocki MA, Surace SJ, Deitch J, McBain B, Lyttle N, Buchbinder R. Electrotherapy modalities for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012225. doi: 10.1002/14651858.CD012225.
- Background: PubMed 25394425Yu H, Cote P, Shearer HM, Wong JJ, Sutton DA, Randhawa KA, Varatharajan S, Southerst D, Mior SA, Ameis A, Stupar M, Nordin M, van der Velde GM, Carroll L, Jacobs CL, Taylor-Vaisey AL, Abdulla S, Shergill Y. Effectiveness of passive physical modalities for shoulder pain: systematic review by the Ontario protocol for traffic injury management collaboration. Phys Ther. 2015 Mar;95(3):306-18. doi: 10.2522/ptj.20140361. Epub 2014 Nov 13.
- Background: PubMed 12952518van den Dolder PA, Roberts DL. A trial into the effectiveness of soft tissue massage in the treatment of shoulder pain. Aust J Physiother. 2003;49(3):183-8. doi: 10.1016/s0004-9514(14)60238-5.
- Background: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
- Individual participant dataSharing planned: Yes. Individual Participant Data can be shared once the study has finished and its subsequent publication with anyone who requires it formally in writing to the Main Investigator
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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.
Gemma G Nin, Ms principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long Lever Group and Short Lever Group in people with Subacromial Impingement Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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: status not confirmed, as of the sponsor's last update on 29 Aug 2019. 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?
Results are not available in the source record.
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?
Pain Intensity (time frame: 2 minutes needed for the explanation and the realization of the measure.). The study lists 4 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 NCT04073199, which also lists 5 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 Aug 2019.