Therapeutic Progressive Exercise on Shoulder Impingement Syndrome

NCT04690049 | Withdrawn

• 1 other identifier: ProgEx-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Shoulder Impingement; Tendinopathy

Keywords

shoulder impingement syndrome; tendinopathy; exercise

Outcome Measures

Primary Outcomes (6)

• 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)

  14 weeks

• 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.

  14 weeks

• 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)

  14 weeks

• Change from baseline Painful Sensation

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

  14 weeks

• Change from baseline Range of motion (ROM)

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

  14 weeks

• Change from baseline Subacromial Space

  Measurement of subacromial space by ultrasonography

  14 weeks

Secondary Outcomes (2)

• Change from baseline Quality of Life

  14 weeks

• Change from baseline Health Status

  14 weeks

Study Arms (2)

Neuromuscular resistance exercise group

EXPERIMENTAL

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.

Other: Neuromuscular resistance exercise program

Control exercise group

ACTIVE COMPARATOR

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.

Other: Control exercise program with elastic band

Interventions

Neuromuscular resistance exercise program OTHER

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.

Neuromuscular resistance exercise group

Control exercise program with elastic band OTHER

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.

Control exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Findings of spinal radiculopathy.
• 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.

Sponsors & Collaborators

• University of Malaga: lead

Related Publications (15)

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  PMID: 15163107 BACKGROUND

• 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.

  PMID: 10696154 BACKGROUND

• 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.

  PMID: 16753088 BACKGROUND

• 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.

  PMID: 18835532 BACKGROUND

• 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.

  PMID: 20846766 BACKGROUND

• 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.

  PMID: 31431267 BACKGROUND

• 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.

  PMID: 29475840 BACKGROUND

• 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.

  PMID: 24970843 BACKGROUND

• 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.

  PMID: 22124602 BACKGROUND

• 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.

  PMID: 21110409 BACKGROUND

• 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.

  PMID: 10226960 BACKGROUND

• 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.

  PMID: 28566400 BACKGROUND

• 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.

  PMID: 27884499 BACKGROUND

• 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.

  PMID: 11032222 BACKGROUND

• 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.

  PMID: 11452048 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Tendinopathy; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Muscular Diseases; Tendon Injuries; Behavior

Study Officials

• Antonio Cuesta-Vargas, PhD

  University of Malaga

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 30, 2020
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04