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Shoulder ImpingementNCT04690049

Therapeutic Progressive Exercise on Shoulder Impingement Syndrome

A study testing Neuromuscular resistance exercise program in people with Shoulder Impingement and Tendinopathy, run by University of Malaga.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Upper limb tendinopathies, especially the so called "shoulder impingement syndrome", is a common injury among the population. Its management usually involves active treatments, being the therapeutic progressive exercise the most important and effective modality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Impingement, Tendinopathy
What is being tested?
Neuromuscular resistance exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2025to Feb 2027
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

  • Subjects older than 18 years.
  • Subjects previously diagnosed with shoulder impingement syndrome.
  • Presence of 3 of the following sings: impingement sign according to Neer and to Hawking-Kennedy, positive result on Jobes test, painful arc, and positive result on Patte's manoeuvre.

Who cannot join

  • Findings of spinal radiculopathy.
  • General neck and shoulder pain.
  • Symptoms of frozen shoulder.
  • Pregnancy.
  • Fybromyalgia.
  • Suspected polyarthritis.
Show all 13Show fewer
  • Chronic pain syndrome.
  • Altered blood coagulation.
  • Consumption of anticoagulants, opioids or antiepileptics.
  • Drug intakes.
  • Alcohol intakes higher than 27.4 grams for men or 13.7 grams for women.
  • Allergies.
  • Cancer.

About this study

Official title: An Innovative Therapeutic Exercise Approach Based on Load Progression Criteria for the Management of Shoulder Impingement Syndrome: a Randomized Controlled Trial

Upper limb tendinopathies, especially the so called "shoulder impingement syndrome", is a common injury among the population. Its management usually involves active treatments, being the therapeutic progressive exercise the most important and effective modality. However, whether a certain criterion is more appropriate than another when progressing the exercise program remains unclear. We propose a new program based on progressive exercises serving as a standard approach for the management of shoulder impingement syndrome.

Read the detailed description

Shoulder pain is a common condition affecting our society. It is estimated that between 7 and 67% of the adult population will suffer from shoulder pain at least once in their lifetime. Some research suggest that shoulder impingement syndrome (SIS) is responsible for 44 to 60% from the medical consultations regarding shoulder pain with an approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health care resources.

Among all the musculoskeletal injuries affecting the shoulder complex, SIS remains as the most common condition, characterized for leading to loss function and disability. Its pathogenesis is associated with the affection of diverse structures and tissues like the subacromial bursa, rotator cuff tendons, acromion, coracoacromial ligament and the long head of biceps brachii. The etiology of this condition comprises multiple causes, including capsular tightness, alteration of shoulder kinematics with scapula dysfunction and muscle imbalance, and also the overuse factor.

Treatment modalities to deal with SIS embrace both surgical procedures, i.e., arthroscopic subacromial decompression) and conservative approaches (i.e., physical therapy), becoming the therapeutic exercise increasingly popular due to arising evidence from the last 30 years. Furthermore, with regard to potential effects, therapeutic exercise presents itself as a safer and less aggressive alternative, causing fewer adverse effects than pharmacological or surgical options, which are relegated preferably as secondary choices.

There is a wide evidence supporting the exercise therapy as an effective strategy for the management of SIS. However, some controversy exists regarding the optimal approach in terms of intensity, frequency and number of repetitions. Thus, a program acting as a gold standard for the development and progression of the proposed exercises is still lacking, especially when attempting to estimate the pure effect of progressive exercise in isolation between experimental and control group.

Prior research evaluating the effect of progressive exercise for the management of SIS usually included programs with a duration of 3 months. However, other studies established follow-up periods of either one month and a half or, conversely, more than 6 months. That, together with the wide variety of post-treatment follow-ups, makes it difficult to find the optimal period where the results derived inherently from the intervention and not from the natural course of the condition may be observed.

Regarding the progression criteria, there seems to be a tendency to consider the modulation of the painful sensation as the main benchmark from which the exercise may progress in difficulty, but some other progression sub-criteria can also be found, such as fatigue or subjective perception. Furthermore, the presence of other conditioning elements, like proximity to pain threshold or a certain reference value in the Visual Analogue Scale (VAS), reduces the homogeneity among the exercise programs and hinders the standardization of the ideal exercise progression when performing the exercises for the management of SIS.

The main objective of this clinical trial is to prove the efficacy of a progressive exercise program based on strength and resistance training in comparison to an exercise protocol from the literature to increase neuromuscular and cardiorespiratory capacities and improve the symptoms in subjects with SIS. In addition, we propose to determine the existence or not of statistically significant differences between treatment modalities by evaluating whether these changes occur before, during or after the application of the proposed exercise protocol.

Being tested
Neuromuscular resistance exercise program, Control exercise program with elastic band
Keywords
shoulder impingement syndrome, tendinopathy, exercise
Medical subject headings
Shoulder Impingement Syndrome, Tendinopathy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular resistance exercise programOther

    This neuromuscular resistance exercise program will be organized in 5 stages, distributing the different phases in 2, 4, 4, 2 and 2 weeks respectively, with a frequency of 3 sessions/week. In addition, 2 weekly sessions of aerobic work with cycloergometer will be developed. The duration of each session will last 30 minutes. The parameters of load and execution speed will be modified as the exercise program progresses along the phases, with the goal of have an impact on the different aspects of the neuromuscular system.

  • Control exercise program with elastic bandOther

    This program is based on previous literature so that it remains comparable to the experimental program.

    The parameters will consist in 3 sets of 10 repetitions, 2 times/day, 3 times/week, for a total of 6 weeks.

Study groups in NCT04690049
Study groupRoleWhat they receive
Neuromuscular resistance exercise groupExperimentalSubjects will develop an innovator program consisting in the performance of exercises of increasing difficulty, with movements based on functional tests to analyze the subjects' neuromuscular capacities. Participants will attend to 80 individual, face-to-face physiotherapy sessions, including both supervised and semi-supervised monitoring. From the total, a minimum of 15 sessions will be supervised, including 6 sessions to teach and monitor the exercises, and 9 sessions to perform the tests in order to quantify the load; 37 sessions will be semi-supervised, where subjects will perform the exercises independently, but with the presence of an instructor; additionally, the remaining 28 sessions will consist in non-supervised aerobic work at a 70-80% from maximum heart rate, obtained according to the methodology of Tanaka et al.
Receives: Other: Neuromuscular resistance exercise program
Control exercise groupActive comparatorThis program will be based on a home exercise protocol considering painful sensation and self-perceived stability as progression criteria: regarding pain management, exercises will be planned in a way that increased pain after their performance reverts to before-exercise levels prior to the next session; regarding self-perceived stability, participants will be asked to maintain a constant sensation of joint stability and control during the execution of the exercises. Participants will perform shoulder rotations (external and internal) and abduction up to 30º by using elastic bands. The resistance of the band will be adjusted by the physiotherapist so that participants perceive the exercises as demanding enough but not too unpleasant, being able to complete the 10 repetitions before taking the rest. Likewise, exercises will progress until a maximum of 90º of shoulder abduction.
Receives: Other: Control exercise program with elastic band

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)

    Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire.

    Score ranges from 0 (no disability) to 100 (most severe disability)

    Measured: 14 weeks

  2. Change from baseline in Function measured with Constant-Murley Score (CMS)

    Functional scores from Constant-Murley Score (CMS) Constant-Murley score (CMS) is a 100-points scale: the higher the score, the higher the quality of the function.

    Measured: 14 weeks

  3. Change from baseline in Function measured with Upper Limb Functional Index (ULFI)

    Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability)

    Measured: 14 weeks

  4. Change from baseline Painful Sensation

    Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain)

    Measured: 14 weeks

  5. Change from baseline Range of motion (ROM)

    Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry

    Measured: 14 weeks

  6. Change from baseline Subacromial Space

    Measurement of subacromial space by ultrasonography

    Measured: 14 weeks

Secondary outcomes (2)
  1. Change from baseline Quality of Life

    Quality of life scores from EuroQol-5D questionnaire

    EQ-5D embodies two components:

    • Health state description: subjects select one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression.
    • Evaluation: using a visual analogue scale (VAS), ranging from 0 ("worst imaginable health state") and at 100 ("best imaginable health state")

    Measured: 14 weeks

  2. Change from baseline Health Status

    Health status scores from Short-Form 12 (SF-12) questionnaire SF-12 gathers information from eight domains: the higher the scores, the better the health)

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start1 Dec 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Why it stopped: No available PhD sutdent

Resources

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 controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690049
Sponsor's protocol ID
ProgEx-01
Status last verified
Apr 2026
First submitted
21 Dec 2020
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If further decided, IPD will be shared under request.

Publications

  • Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.

    PubMed 15163107
  • Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.

    PubMed 10696154
  • Marin-Gomez M, Navarro-Collado MJ, Peiro S, Trenor-Gomis C, Paya-Rubio A, Bernal-Delgado E, Hernandez-Royo A. [The quality of care in shoulder pain. A medical audit]. Gac Sanit. 2006 Mar-Apr;20(2):116-23. doi: 10.1157/13087322. Spanish.

    PubMed 16753088
  • Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2.

    PubMed 18835532
  • Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16.

    PubMed 20846766
  • Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8.

    PubMed 31431267
  • Cook JL. Ten treatments to avoid in patients with lower limb tendon pain. Br J Sports Med. 2018 Jul;52(14):882. doi: 10.1136/bjsports-2018-099045. Epub 2018 Feb 23. No abstract available.

    PubMed 29475840
  • Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.

    PubMed 24970843
  • Holmgren T, Oberg B, Sjoberg I, Johansson K. Supervised strengthening exercises versus home-based movement exercises after arthroscopic acromioplasty: a randomized clinical trial. J Rehabil Med. 2012 Jan;44(1):12-8. doi: 10.2340/16501977-0889.

    PubMed 22124602
  • Osteras H, Torstensen TA, Osteras B. High-dosage medical exercise therapy in patients with long-term subacromial shoulder pain: a randomized controlled trial. Physiother Res Int. 2010 Dec;15(4):232-42. doi: 10.1002/pri.468.

    PubMed 21110409
  • Brox JI, Gjengedal E, Uppheim G, Bohmer AS, Brevik JI, Ljunggren AE, Staff PH. Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up. J Shoulder Elbow Surg. 1999 Mar-Apr;8(2):102-11. doi: 10.1016/s1058-2746(99)90001-0.

    PubMed 10226960
  • Ketola S, Lehtinen JT, Arnala I. Arthroscopic decompression not recommended in the treatment of rotator cuff tendinopathy: a final review of a randomised controlled trial at a minimum follow-up of ten years. Bone Joint J. 2017 Jun;99-B(6):799-805. doi: 10.1302/0301-620X.99B6.BJJ-2016-0569.R1.

    PubMed 28566400
  • Heron SR, Woby SR, Thompson DP. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: A randomized controlled trial. Physiotherapy. 2017 Jun;103(2):167-173. doi: 10.1016/j.physio.2016.09.001. Epub 2016 Sep 21.

    PubMed 27884499
  • Tyler TF, Nicholas SJ, Roy T, Gleim GW. Quantification of posterior capsule tightness and motion loss in patients with shoulder impingement. Am J Sports Med. 2000 Sep-Oct;28(5):668-73. doi: 10.1177/03635465000280050801.

    PubMed 11032222
  • Miranda H, Viikari-Juntura E, Martikainen R, Takala EP, Riihimaki H. A prospective study of work related factors and physical exercise as predictors of shoulder pain. Occup Environ Med. 2001 Aug;58(8):528-34. doi: 10.1136/oem.58.8.528.

    PubMed 11452048

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular resistance exercise program in people with Shoulder Impingement and Tendinopathy, run by University of Malaga.

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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH) (time frame: 14 weeks). The study lists 6 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 NCT04690049, which also lists 15 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 8 Apr 2026.

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