Posterior Shoulder TightnessNCT05128448
Comparative Effects of Two Procedures for the Management of Posterior Shoulder Tightness
A study testing Cross-body stretch (CBS) and Mobilisation with movement (MWM) in people with Posterior Shoulder Tightness, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to compare the effects of a self-stretch procedures versus a clinician applied musculoskeletal procedure in individuals with posterior shoulder tightness. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Shoulder Tightness
- What is being tested?
- Cross-body stretch (CBS) and Mobilisation with movement (MWM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Oct 2021to 28 Feb 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic individuals without any history of shoulder pain necessitating medical attention.
- Presence of unilateral restriction of at least 10 degrees of internal rotation deficit during the internal rotation mobility test in 90 degrees of shoulder abduction.
Who cannot join
- Asymptomatic individuals that present with shoulder pain on the assessment day.
- Individuals with chronic conditions not affecting the shoulder.
- Individuals with clinical depression.
- Individuals that used analgesic and/or anti-inflammatory medication in the previous 24 hours of assessment.
- Individuals with fibromialgia.
- Individuals engaged in overhead sports.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdades Integradas de Taquara
Taquara, Rio Grande do Sul, 95612-150
About this study
This study aims to compare the effects of a self-stretch procedures versus a clinician applied musculoskeletal procedure in individuals with posterior shoulder tightness.
Read the detailed description
Posterior shoulder mobility has been considered a contributing factor to shoulder related movement dysfunction. There is evidence indicating that posterior shoulder tightness (PST) might be present in individuals with impingement related symptoms, post-operative conditions and overhead athletes. Several studies have investigated the effects of musculoskeletal procedures (joint mobilisations and stretch) in subjects with posterior shoulder tightness (PST). This cross-over design aims to compare the differences between a well-established procedure - the crossbody stretch - versus mobilisation with movement, on range of motion and pain pressure threshold of asymptomatic individuals with unilateral PST.
- Conditions
- Posterior Shoulder Tightness
- Being tested
- Cross-body stretch (CBS), Mobilisation with movement (MWM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-body stretch (CBS)Other
CBS is a self administered stretch that aims to stretch posterior shoulder structures
Mobilisation with movement (MWM)Other
WMW is a musculoskeletal procedure that aims to improve restricted and/or painful range of movement
| Study group | Role | What they receive |
|---|---|---|
| Mobilisation with movement (MWM) | Experimental | With the participant standing, the restricted shoulder will rest on the clinician's shoulder in the following starting position: 90 degrees of glenohumeral abduction and 90 degrees of elbow flexion and hand holding a treatment belt. The belt will loop around the clinician and patient and will be held by the participant's contralateral hand. The clinician will apply and sustain a pain free caudal or posterolateralcaudal humeral head mobilisation force (whichever is more comfortable to the subject), followed by an active internal rotation (IR) performed by the patient. The IR movement will be performed to a pain free end of range. If possible, an overpressure with be requested, this is achieved by pulling the belt with the contralateral hand. The overpressure should not produce pain, if it does, it will not be performed.
3 sets of 8 repetitions will be applied, sustaining the end of available range for 2 seconds. An interval of 45 seconds will be respected amongst the repetitions. Receives: Other: Mobilisation with movement (MWM) |
| Cross-body stretch | Active comparator | With the participant standing, the restricted shoulder will be self-stretched by conducting a horizontal adduction in 90 degrees of shoulder flexion to a level tolerated by the participant. This position will be held for thirty seconds and repeated four times. An interval of forty five seconds will be respected amongst the repetitions. Receives: Other: Cross-body stretch (CBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal adduction
Horizontal adduction in 90 degrees of shoulder flexion
Measured: change immediately after the intervention
Internal rotation
Internal rotation at 90 degrees of shoulder abduction
Measured: change immediately after the intervention
Secondary outcomes (1)
Mechanical sensitivity
Pain pressure threshold with an algometer (Wagner instruments, FPX 25)
Measured: change immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start17 Oct 2021
- Primary completion20 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Posterior Shoulder TightnessStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Baeske, Federal University of Health Science of Porto Alegre
- Investigators
- Marcelo Faria Silva, PhD, Study chair, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128448
- Sponsor's protocol ID
- FACCAT
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be provided on reasonable request.
Publications
Picavet HS, Schouten JS. Musculoskeletal pain in the Netherlands: prevalences, consequences and risk groups, the DMC(3)-study. Pain. 2003 Mar;102(1-2):167-78. doi: 10.1016/s0304-3959(02)00372-x.
PubMed 12620608Hall K, Borstad JD. Posterior Shoulder Tightness: To Treat or Not to Treat? J Orthop Sports Phys Ther. 2018 Mar;48(3):133-136. doi: 10.2519/jospt.2018.0605.
PubMed 29490601Schwartz C, Croisier JL, Bruls O, Denoel V, Forthomme B. Tight shoulders: A clinical, kinematic and strength comparison of symptomatic and asymptomatic male overhead athletes before and after stretching. Eur J Sport Sci. 2021 May;21(5):781-791. doi: 10.1080/17461391.2020.1785015. Epub 2020 Jul 7.
PubMed 32635824Rosa DP, Borstad JD, Ferreira JK, Camargo PR. The Influence of Glenohumeral Joint Posterior Capsule Tightness and Impingement Symptoms on Shoulder Impairments and Kinematics. Phys Ther. 2019 Jul 1;99(7):870-881. doi: 10.1093/ptj/pzz052.
PubMed 30921461Tyler TF, Nicholas SJ, Lee SJ, Mullaney M, McHugh MP. Correction of posterior shoulder tightness is associated with symptom resolution in patients with internal impingement. Am J Sports Med. 2010 Jan;38(1):114-9. doi: 10.1177/0363546509346050. Epub 2009 Dec 4.
PubMed 19966099Salamh PA, Kolber MJ, Hegedus EJ, Cook CE. The efficacy of stretching exercises to reduce posterior shoulder tightness acutely in the postoperative population: a single blinded randomized controlled trial. Physiother Theory Pract. 2018 Feb;34(2):111-120. doi: 10.1080/09593985.2017.1376020. Epub 2017 Sep 13.
PubMed 28901811Salamh PA, Liu X, Kolber MJ, Hanney WJ, Hegedus EJ. The reliability, validity, and methodologic quality of measurements used to quantify posterior shoulder tightness: a systematic review of the literature with meta-analysis. J Shoulder Elbow Surg. 2019 Jan;28(1):178-185. doi: 10.1016/j.jse.2018.07.013. Epub 2018 Oct 1.
PubMed 30287146Mine K, Nakayama T, Milanese S, Grimmer K. Effectiveness of Stretching on Posterior Shoulder Tightness and Glenohumeral Internal-Rotation Deficit: A Systematic Review of Randomized Controlled Trials. J Sport Rehabil. 2017 Jul;26(4):294-305. doi: 10.1123/jsr.2015-0172. Epub 2016 Aug 24.
PubMed 27632891Salamh PA, Liu X, Hanney WJ, Sprague PA, Kolber MJ. The efficacy and fidelity of clinical interventions used to reduce posterior shoulder tightness: a systematic review with meta-analysis. J Shoulder Elbow Surg. 2019 Jun;28(6):1204-1213. doi: 10.1016/j.jse.2018.12.006. Epub 2019 Mar 20.
PubMed 30902594Kang MH, Oh JS. Effects of self-stretching with mobilization on shoulder range of motion in individuals with glenohumeral internal rotation deficits: a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jan;29(1):36-43. doi: 10.1016/j.jse.2019.08.007. Epub 2019 Oct 15.
PubMed 31627965Hall K, Lewis J, Moore A, Ridehalgh C. Posterior shoulder tightness; an intersession reliability study of 3 clinical tests. Arch Physiother. 2020 Jul 29;10:14. doi: 10.1186/s40945-020-00084-w. eCollection 2020.
PubMed 32742721Oliveira VMA, Pitangui ACR, Gomes MRA, Silva HAD, Passos MHPD, Araujo RC. Shoulder pain in adolescent athletes: prevalence, associated factors and its influence on upper limb function. Braz J Phys Ther. 2017 Mar-Apr;21(2):107-113. doi: 10.1016/j.bjpt.2017.03.005. Epub 2017 Mar 17.
PubMed 28460708
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Two Procedures for the Management of Posterior Shoulder Tightness
- ClinicalTrials.gov ID
- NCT05128448
- Acronym / sponsor ID
- FACCAT
- Conditions
- Posterior Shoulder Tightness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 22 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.
This study aims to compare the effects of a self-stretch procedures versus a clinician applied musculoskeletal procedure in individuals with posterior shoulder tightness.
Detailed description
Posterior shoulder mobility has been considered a contributing factor to shoulder related movement dysfunction. There is evidence indicating that posterior shoulder tightness (PST) might be present in individuals with impingement related symptoms, post-operative conditions and overhead athletes. Several studies have investigated the effects of musculoskeletal procedures (joint mobilisations and stretch) in subjects with posterior shoulder tightness (PST). This cross-over design aims to compare the differences between a well-established procedure - the crossbody stretch - versus mobilisation with movement, on range of motion and pain pressure threshold of asymptomatic individuals with unilateral PST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilisation with movement (MWM) | Experimental | Other: Mobilisation with movement (MWM)With the participant standing, the restricted shoulder will rest on the clinician's shoulder in the following starting position: 90 degrees of glenohumeral abduction and 90 degrees of elbow flexion and hand holding a treatment belt. The belt will loop around the clinician and patient and will be held by the participant's contralateral hand. The clinician will apply and sustain a pain free caudal or posterolateralcaudal humeral head mobilisation force (whichever is more comfortable to the subject), followed by an active internal rotation (IR) performed by the patient. The IR movement will be performed to a pain free end of range. If possible, an overpressure with be requested, this is achieved by pulling the belt with the contralateral hand. The overpressure should not produce pain, if it does, it will not be performed. 3 sets of 8 repetitions will be applied, sustaining the end of available range for 2 seconds. An interval of 45 seconds will be respected amongst the repetitions. |
| Cross-body stretch | Active comparator | Other: Cross-body stretch (CBS)With the participant standing, the restricted shoulder will be self-stretched by conducting a horizontal adduction in 90 degrees of shoulder flexion to a level tolerated by the participant. This position will be held for thirty seconds and repeated four times. An interval of forty five seconds will be respected amongst the repetitions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Asymptomatic individuals without any history of shoulder pain necessitating medical attention.
- Presence of unilateral restriction of at least 10 degrees of internal rotation deficit during the internal rotation mobility test in 90 degrees of shoulder abduction.
Key exclusion criteria (6 listed)
- Asymptomatic individuals that present with shoulder pain on the assessment day.
- Individuals with chronic conditions not affecting the shoulder.
- Individuals with clinical depression.
- Individuals that used analgesic and/or anti-inflammatory medication in the previous 24 hours of assessment.
- Individuals with fibromialgia.
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 |
|---|---|---|
| Cross-body stretch (CBS)CBS is a self administered stretch that aims to stretch posterior shoulder structures | Other | Cross-body stretch |
| Mobilisation with movement (MWM)WMW is a musculoskeletal procedure that aims to improve restricted and/or painful range of movement | Other | Mobilisation with movement (MWM) |
Primary outcome
Horizontal adduction
Time frame: change immediately after the intervention
Horizontal adduction in 90 degrees of shoulder flexion
Internal rotation
Time frame: change immediately after the intervention
Internal rotation at 90 degrees of shoulder abduction
1 secondary outcome
Mechanical sensitivity
Time frame: change immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 12620608Picavet HS, Schouten JS. Musculoskeletal pain in the Netherlands: prevalences, consequences and risk groups, the DMC(3)-study. Pain. 2003 Mar;102(1-2):167-78. doi: 10.1016/s0304-3959(02)00372-x.
- Background: PubMed 29490601Hall K, Borstad JD. Posterior Shoulder Tightness: To Treat or Not to Treat? J Orthop Sports Phys Ther. 2018 Mar;48(3):133-136. doi: 10.2519/jospt.2018.0605.
- Background: PubMed 32635824Schwartz C, Croisier JL, Bruls O, Denoel V, Forthomme B. Tight shoulders: A clinical, kinematic and strength comparison of symptomatic and asymptomatic male overhead athletes before and after stretching. Eur J Sport Sci. 2021 May;21(5):781-791. doi: 10.1080/17461391.2020.1785015. Epub 2020 Jul 7.
- Background: PubMed 30921461Rosa DP, Borstad JD, Ferreira JK, Camargo PR. The Influence of Glenohumeral Joint Posterior Capsule Tightness and Impingement Symptoms on Shoulder Impairments and Kinematics. Phys Ther. 2019 Jul 1;99(7):870-881. doi: 10.1093/ptj/pzz052.
- Background: PubMed 19966099Tyler TF, Nicholas SJ, Lee SJ, Mullaney M, McHugh MP. Correction of posterior shoulder tightness is associated with symptom resolution in patients with internal impingement. Am J Sports Med. 2010 Jan;38(1):114-9. doi: 10.1177/0363546509346050. Epub 2009 Dec 4.
- Background: PubMed 28901811Salamh PA, Kolber MJ, Hegedus EJ, Cook CE. The efficacy of stretching exercises to reduce posterior shoulder tightness acutely in the postoperative population: a single blinded randomized controlled trial. Physiother Theory Pract. 2018 Feb;34(2):111-120. doi: 10.1080/09593985.2017.1376020. Epub 2017 Sep 13.
- Background: PubMed 30287146Salamh PA, Liu X, Kolber MJ, Hanney WJ, Hegedus EJ. The reliability, validity, and methodologic quality of measurements used to quantify posterior shoulder tightness: a systematic review of the literature with meta-analysis. J Shoulder Elbow Surg. 2019 Jan;28(1):178-185. doi: 10.1016/j.jse.2018.07.013. Epub 2018 Oct 1.
- Background: PubMed 27632891Mine K, Nakayama T, Milanese S, Grimmer K. Effectiveness of Stretching on Posterior Shoulder Tightness and Glenohumeral Internal-Rotation Deficit: A Systematic Review of Randomized Controlled Trials. J Sport Rehabil. 2017 Jul;26(4):294-305. doi: 10.1123/jsr.2015-0172. Epub 2016 Aug 24.
- Background: PubMed 30902594Salamh PA, Liu X, Hanney WJ, Sprague PA, Kolber MJ. The efficacy and fidelity of clinical interventions used to reduce posterior shoulder tightness: a systematic review with meta-analysis. J Shoulder Elbow Surg. 2019 Jun;28(6):1204-1213. doi: 10.1016/j.jse.2018.12.006. Epub 2019 Mar 20.
- Background: PubMed 31627965Kang MH, Oh JS. Effects of self-stretching with mobilization on shoulder range of motion in individuals with glenohumeral internal rotation deficits: a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jan;29(1):36-43. doi: 10.1016/j.jse.2019.08.007. Epub 2019 Oct 15.
- Background: PubMed 32742721Hall K, Lewis J, Moore A, Ridehalgh C. Posterior shoulder tightness; an intersession reliability study of 3 clinical tests. Arch Physiother. 2020 Jul 29;10:14. doi: 10.1186/s40945-020-00084-w. eCollection 2020.
- Results publication: PubMed 28460708Oliveira VMA, Pitangui ACR, Gomes MRA, Silva HAD, Passos MHPD, Araujo RC. Shoulder pain in adolescent athletes: prevalence, associated factors and its influence on upper limb function. Braz J Phys Ther. 2017 Mar-Apr;21(2):107-113. doi: 10.1016/j.bjpt.2017.03.005. Epub 2017 Mar 17.
- Individual participant dataSharing planned: Undecided. Data will be provided on reasonable request.
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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.
Marcelo Faria Silva, PhD study chair
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-body stretch (CBS) and Mobilisation with movement (MWM) in people with Posterior Shoulder Tightness, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 2 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 22 Nov 2021. 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 Brazil. 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?
Horizontal adduction (time frame: change immediately after the intervention). 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 NCT05128448, which also lists 12 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 22 Nov 2021.