Therapeutic Progressive Exercise on Shoulder Impingement Syndrome
NCT ID: NCT04690049
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-30
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Neuromuscular resistance exercise group
Subjects 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.
Neuromuscular resistance exercise program
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 group
This 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.
Control exercise program with elastic band
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.
Interventions
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Neuromuscular resistance exercise program
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 band
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* General neck and shoulder pain.
* Symptoms of frozen shoulder.
* Pregnancy.
* Fybromyalgia.
* Suspected polyarthritis.
* 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.
18 Years
ALL
No
Sponsors
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University of Malaga
OTHER
Responsible Party
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Dr. Antonio I Cuesta-Vargas
Professor
Principal Investigators
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Antonio Cuesta-Vargas, PhD
Role: STUDY_CHAIR
University of Malaga
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ProgEx-01
Identifier Type: -
Identifier Source: org_study_id