Rotator Cuff InjuriesNCT04175184
Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
A study testing Mobilisation with Movement in people with Rotator Cuff Injuries and Shoulder Pain, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial summary
Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Pain
- What is being tested?
- Mobilisation with Movement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2020to 11 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral shoulder pain of atraumatic origin.
- Complaining of shoulder pain for at least six weeks.
- Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable).
- Pain on active shoulder movement
- Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can.
- Participants referred by a specialist under the diagnosis of subacromial impingement syndrome, rotator cuff tendinopathy, partial rotator cuff tears, subacromial pain, bursitis.
Who cannot join
- Shoulder pain following a traumatic event.
- History compatible with complete rotator cuff and biceps rupture.
- Adhesive capsulitis.
- History of dislocation.
- Glenohumeral osteoarthritis.
- Cancer
Show all 14Show fewer
- Systemic, local or self-immune inflammatory conditions.
- Previous shoulder or neck surgery.
- Familiar pain provoked by neck movements.
- Presence of radicular signs.
- Use of corticosteroids over the past six months.
- Diagnosis of fibromyalgia.
- Participants with clinical depression
- Participants under treatment for her/his shoulder condition.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Albrecht - Clínica Integrada de Reabilitação
São Leopoldo, Rio Grande do Sul, 93020-080
Faculdades Integradas de Taquara
Taquara, Rio Grande do Sul, 95612-150
About this study
Official title: The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. The use of manual therapy in the management of this condition has been debated and studies have shown contradictory results. A specific manual therapy approach, mobilisation with movement (MWM), seems promising in this population as it aims to improve pain-free range of motion and includes active engagement of the participant.
Read the detailed description
Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable.
Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction,
Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain
- Being tested
- Mobilisation with Movement, Sham Mobilisation with Movement
- Keywords
- rotator cuff pain, mobilisation with movement, exercises
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilisation with MovementOther
Also called MWM, Mobilization with movement
MWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results.
The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion.
Sham Mobilisation with MovementOther
Also called sham MWM, sham Mobilization with movement
Sham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. Exercise programme: 2-3 sets of 10-15 repetitions of shoulder girdle and glenohumeral strengthening exercises performed in different positions in addition to three stretching exercises.
2. Mobilisation with movement (MWM): the participant and physiotherapist will decide one movement more functionally relevant to the patient. Afterwards, attempts of MWM will be applied to different joints in order to identify one particular MWM that improves significantly the movement previously selected. Then, one set of six to ten repetitions will be applied. This process of pragmatically using MWM will be conducted in every session, but from the second session onwards, two to three sets of ten repetitions will be applied, with an interval of sixty seconds between sets. In case of failure to identify an MWM that improves the movement significantly, the patient decides which one seemed to be best and one set of six repetitions will be applied to the onset of discomfort. Receives: Other: Mobilisation with Movement |
| Placebo group | Sham comparator | 1. The exercise programme is exactly the same as the experimental group.
2. Sham MWM: the participant and physiotherapist will decide together one movement that is more functionally relevant to the patient. Afterwards, a sham MWM (Delgado-Gil et al 2015) will be applied and the movement previously selected will be repeated six times in the first consultation. The participant will be informed that he/she should move to the onset of symptoms, if they occur.This process will be conducted in every session, but from the second session onwards, two to three sets of 10 repetitions will be applied, with an interval of sixty seconds between sets. In case the sham MWM failed to improve the movement significantly, one set of six repetitions will be applied only. Receives: Other: Sham Mobilisation with Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain Disability Index (SPADI).
SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
Measured: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Visual Analogue Scale (VAS) for pain.
VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Secondary outcomes (4)
Active pain-free range of motion.
Active pain-free range of motion will be assessed for flexion, abduction (Kolber et al, 2011), external rotation (Cools et al, 2014) and hand behind back (Satpute et al, 2016). An inclinometer (Baseline, Enterprises Inc) will be used to measure the ranges of motion.
All measurements will be conducted to the onset of pain.
Measured: Changes from baseline and study completion (5 weeks).
Pain pressure threshold
Measurements will be collected at three different sides: 5 cm distal to the lateral border of the acromion on both sides over the deltoid muscle, and 10 cm distal to the tibiofemoral joint line, over the tibialis anterior muscle on the unaffected side (Paul et al, 2012). A calibrated digital algometer (Wagner instruments, model FPX 25) will be used to assess the pain pressure threshold.
An interval of 30 seconds will be respected between measurements.
Measured: Changes from baseline and study completion (5 weeks).
Global rating scale of change (GROC)
GROC is designed to measure a patient's improvement or deterioration over time as a result of an intervention.The amplitude of this difference is scored on a numerical or visual analogue scale. In this research a 15 point scale will be used (Kamper et al, 2009).
Measured: Through study completion and 4 weeks follow-up.
Expectations of physiotherapy
The scale to be used in this study to assess expectation has been previously used in patients with shoulder disorders (Chester et al, 2018). Participants will answer the following question: "How much do you expect your shoulder problem to change as a result of physiotherapy treatment?. Please circle one box only".
Possible answers are: Completely recover, Much improve, Slightly improve, No change, Slightly worse, Much worse, Worse than ever.
Measured: Change at 3 weeks of treatment from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Sep 2020
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies 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
- Model description
- Randomized clinical trial, placebo-controlled, with a parallel group design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175184
- Sponsor's protocol ID
- 10534119.5.0000.5345
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009 Apr;43(4):259-64. doi: 10.1136/bjsm.2008.052183. Epub 2008 Oct 6.
PubMed 18838403Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.
PubMed 17720798Hegedus EJ, Cook C, Lewis J, Wright A, Park JY. Combining orthopedic special tests to improve diagnosis of shoulder pathology. Phys Ther Sport. 2015 May;16(2):87-92. doi: 10.1016/j.ptsp.2014.08.001. Epub 2014 Aug 10.
PubMed 25178255Gismervik SO, Drogset JO, Granviken F, Ro M, Leivseth G. Physical examination tests of the shoulder: a systematic review and meta-analysis of diagnostic test performance. BMC Musculoskelet Disord. 2017 Jan 25;18(1):41. doi: 10.1186/s12891-017-1400-0.
PubMed 28122541Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
PubMed 20450423Minagawa H, Yamamoto N, Abe H, Fukuda M, Seki N, Kikuchi K, Kijima H, Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village. J Orthop. 2013 Feb 26;10(1):8-12. doi: 10.1016/j.jor.2013.01.008. eCollection 2013.
PubMed 24403741Schwartzberg R, Reuss BL, Burkhart BG, Butterfield M, Wu JY, McLean KW. High Prevalence of Superior Labral Tears Diagnosed by MRI in Middle-Aged Patients With Asymptomatic Shoulders. Orthop J Sports Med. 2016 Jan 5;4(1):2325967115623212. doi: 10.1177/2325967115623212. eCollection 2016 Jan.
PubMed 26779556Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.
PubMed 29157224Picavet 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 12620608Karel YHJM, Verhagen AP, Thoomes-de Graaf M, Duijn E, van den Borne MPJ, Beumer A, Ottenheijm RPG, Dinant GJ, Koes BW, Scholten-Peeters GGM. Development of a Prognostic Model for Patients With Shoulder Complaints in Physical Therapist Practice. Phys Ther. 2017 Jan 1;97(1):72-80. doi: 10.2522/ptj.20150649.
PubMed 27538898Abdulla SY, Southerst D, Cote P, Shearer HM, Sutton D, Randhawa K, Varatharajan S, Wong JJ, Yu H, Marchand AA, Chrobak K, Woitzik E, Shergill Y, Ferguson B, Stupar M, Nordin M, Jacobs C, Mior S, Carroll LJ, van der Velde G, Taylor-Vaisey A. Is exercise effective for the management of subacromial impingement syndrome and other soft tissue injuries of the shoulder? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):646-56. doi: 10.1016/j.math.2015.03.013. Epub 2015 Apr 1.
PubMed 25920340Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
PubMed 27283590Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
PubMed 28630217Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30.
PubMed 25936465Teys P, Bisset L, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on range of movement and pressure pain threshold in pain-limited shoulders. Man Ther. 2008 Feb;13(1):37-42. doi: 10.1016/j.math.2006.07.011. Epub 2006 Oct 27.
PubMed 17070090
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
- ClinicalTrials.gov ID
- NCT04175184
- Acronym / sponsor ID
- 10534119.5.0000.5345
- Conditions
- Rotator Cuff Injuries, Shoulder Pain
- Keywords
- rotator cuff pain, mobilisation with movement, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 22 Nov 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.
Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. The use of manual therapy in the management of this condition has been debated and studies have shown contradictory results. A specific manual therapy approach, mobilisation with movement (MWM), seems promising in this population as it aims to improve pain-free range of motion and includes active engagement of the participant.
Detailed description
Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable.
Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction,
Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, placebo-controlled, with a parallel group design
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Mobilisation with Movement1. Exercise programme: 2-3 sets of 10-15 repetitions of shoulder girdle and glenohumeral strengthening exercises performed in different positions in addition to three stretching exercises. 2. Mobilisation with movement (MWM): the participant and physiotherapist will decide one movement more functionally relevant to the patient. Afterwards, attempts of MWM will be applied to different joints in order to identify one particular MWM that improves significantly the movement previously selected. Then, one set of six to ten repetitions will be applied. This process of pragmatically using MWM will be conducted in every session, but from the second session onwards, two to three sets of ten repetitions will be applied, with an interval of sixty seconds between sets. In case of failure to identify an MWM that improves the movement significantly, the patient decides which one seemed to be best and one set of six repetitions will be applied to the onset of discomfort. |
| Placebo group | Sham comparator | Other: Sham Mobilisation with Movement1. The exercise programme is exactly the same as the experimental group. 2. Sham MWM: the participant and physiotherapist will decide together one movement that is more functionally relevant to the patient. Afterwards, a sham MWM (Delgado-Gil et al 2015) will be applied and the movement previously selected will be repeated six times in the first consultation. The participant will be informed that he/she should move to the onset of symptoms, if they occur.This process will be conducted in every session, but from the second session onwards, two to three sets of 10 repetitions will be applied, with an interval of sixty seconds between sets. In case the sham MWM failed to improve the movement significantly, one set of six repetitions will be applied only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral shoulder pain of atraumatic origin.
- Complaining of shoulder pain for at least six weeks.
- Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable).
- Pain on active shoulder movement
- Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can.
Key exclusion criteria (14 listed)
- Shoulder pain following a traumatic event.
- History compatible with complete rotator cuff and biceps rupture.
- Adhesive capsulitis.
- History of dislocation.
- Glenohumeral osteoarthritis.
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 |
|---|---|---|
| Mobilisation with MovementAlso: MWM, Mobilization with movementMWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results. The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion. | Other | Experimental group |
| Sham Mobilisation with MovementAlso: sham MWM, sham Mobilization with movementSham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms. | Other | Placebo group |
Primary outcome
Shoulder Pain Disability Index (SPADI).
Time frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
Visual Analogue Scale (VAS) for pain.
Time frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
4 secondary outcomes
Active pain-free range of motion.
Time frame: Changes from baseline and study completion (5 weeks).
Pain pressure threshold
Time frame: Changes from baseline and study completion (5 weeks).
Global rating scale of change (GROC)
Time frame: Through study completion and 4 weeks follow-up.
Expectations of physiotherapy
Time frame: Change at 3 weeks of treatment from baseline
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 15 Oct 2024.
- Background: PubMed 18838403Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009 Apr;43(4):259-64. doi: 10.1136/bjsm.2008.052183. Epub 2008 Oct 6.
- Background: PubMed 17720798Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.
- Background: PubMed 25178255Hegedus EJ, Cook C, Lewis J, Wright A, Park JY. Combining orthopedic special tests to improve diagnosis of shoulder pathology. Phys Ther Sport. 2015 May;16(2):87-92. doi: 10.1016/j.ptsp.2014.08.001. Epub 2014 Aug 10.
- Background: PubMed 28122541Gismervik SO, Drogset JO, Granviken F, Ro M, Leivseth G. Physical examination tests of the shoulder: a systematic review and meta-analysis of diagnostic test performance. BMC Musculoskelet Disord. 2017 Jan 25;18(1):41. doi: 10.1186/s12891-017-1400-0.
- Background: PubMed 20450423Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
- Background: PubMed 24403741Minagawa H, Yamamoto N, Abe H, Fukuda M, Seki N, Kikuchi K, Kijima H, Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village. J Orthop. 2013 Feb 26;10(1):8-12. doi: 10.1016/j.jor.2013.01.008. eCollection 2013.
- Background: PubMed 26779556Schwartzberg R, Reuss BL, Burkhart BG, Butterfield M, Wu JY, McLean KW. High Prevalence of Superior Labral Tears Diagnosed by MRI in Middle-Aged Patients With Asymptomatic Shoulders. Orthop J Sports Med. 2016 Jan 5;4(1):2325967115623212. doi: 10.1177/2325967115623212. eCollection 2016 Jan.
- Background: PubMed 29157224Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.
- 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 27538898Karel YHJM, Verhagen AP, Thoomes-de Graaf M, Duijn E, van den Borne MPJ, Beumer A, Ottenheijm RPG, Dinant GJ, Koes BW, Scholten-Peeters GGM. Development of a Prognostic Model for Patients With Shoulder Complaints in Physical Therapist Practice. Phys Ther. 2017 Jan 1;97(1):72-80. doi: 10.2522/ptj.20150649.
- Background: PubMed 25920340Abdulla SY, Southerst D, Cote P, Shearer HM, Sutton D, Randhawa K, Varatharajan S, Wong JJ, Yu H, Marchand AA, Chrobak K, Woitzik E, Shergill Y, Ferguson B, Stupar M, Nordin M, Jacobs C, Mior S, Carroll LJ, van der Velde G, Taylor-Vaisey A. Is exercise effective for the management of subacromial impingement syndrome and other soft tissue injuries of the shoulder? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):646-56. doi: 10.1016/j.math.2015.03.013. Epub 2015 Apr 1.
- Background: PubMed 27283590Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
- 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.
Marcelo Faria, PhD principal investigator
Federal University of Health Science of Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilisation with Movement in people with Rotator Cuff Injuries and Shoulder Pain, run by Federal University of Health Science of Porto Alegre at 2 sites 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 6 inclusion and 14 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Shoulder Pain Disability Index (SPADI). (time frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.). 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 NCT04175184, which also lists 28 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 15 Oct 2024.