Effect of the Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule

NCT06509516 | Not Yet Recruiting

• 1 other identifier: 2024/3/066
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental study is to determine the effect of the self-administered Modified Sleeper-Stretch on the elasticity of the posterior and posteroinferior glenohumeral capsule in adult individuals of both genders who either have clinical history of non-specific shoulder pain in a single shoulder or have no history of shoulder pain at all, being the assessment made by means of shear wave elastography. The main hypothesis it aims to confirm is: • A soft tissue stretching program, using the Modified Sleeper-Stretch, aimed at general adult population with history of nonspecific shoulder pain that has occurred with glenohumeral internal rotation deficit improves the elasticity of the posterior and posteroinferior glenohumeral capsules, showing no significant effect on general adult population without history of shoulder pain. Researchers will compare the effect of the Modified Sleeper-Stretch in the elasticity of the posterior and posteroinferior glenohumeral capsule in individuals with history of shoulder pain applying the technique on the affected shoulder and comparing with the healthy shoulder. In healthy individuals the intervention will be made on a randomly assigned shoulder and the effect will be compared to the non-interventional shoulder. Finally, a comparison between groups will be made considering only the intervention shoulder to see if there are differences in the effect amongst healthy and affected individuals. Participants will be asked to follow a self-administered Modified Sleeper-Stretch program consisting of the execution of the stretch three times, for thirty seconds each time, with thirty seconds between stretches, daily, for twenty-eight days.

Conditions

Shoulder Pain; Shoulder Pain Chronic

Keywords

Modified Sleeper-Stretch; Shear Wave Elastography; Posterior Capsule; GIRD

Outcome Measures

Primary Outcomes (2)

• Posterior glenohumeral capsule elasticity

  Elasticity of posterior glenohumeral capsule as determined by quantitative shear-wave elastography

  Day 1 (twice), day 28 (twice), day 56 (once)

• Posteroinferior glenohumeral capsule elasticity

  Elasticity of posteroinferior glenohumeral capsule as determined by quantitative shear-wave elastography

  Day 1 (twice), day 28 (twice), day 56 (once)

Study Arms (2)

Shoulder pain history

EXPERIMENTAL

Execution of the Modified Sleeper-Stretch three times, for thirty seconds each time, with thirty seconds between stretches, daily, for twenty-eight days. The stretch will be applied on the shoulder with history of shoulder pain.

Other: Modified Sleeper-Stretch

No history of shoulder pain

EXPERIMENTAL

Execution of the Modified Sleeper-Stretch three times, for thirty seconds each time, with thirty seconds between stretches, daily, for twenty-eight days. The stretch will be applied on a shoulder randomly assigned.

Other: Modified Sleeper-Stretch

Interventions

Modified Sleeper-Stretch OTHER

Self-administered stretch in which the individual remains side-lying on the upper limb to be stretched, keeping the scapula stabilized by his/her own weight, and rolls the trunk 20-30º posteriorly, maintaining a 90º flexion in the shoulder and elbow. Using the opposite hand over the forearm of the limb to be stretched, the individual passively brings the shoulder to maximum internal rotation.

No history of shoulder pain; Shoulder pain history

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female with clinical history of nonspecific shoulder pain on a single shoulder, who had GIRD of 15º or more, asymptomatic for more than one month and less than one year.
• Male or female with no history of shoulder pain.
• Age between 18 and 59 years.

You may not qualify if:

• Glenohumeral osteoarthritis.
• Labrum lesion, Bankart or Hill-Sachs lesion.
• Posterior instability of any of the shoulders.
• Evidence of joint hypermobility as defined by a Beighton Scale score greater or equal to 6.
• Rotator cuff tear.
• Fracture or surgery in the cervical region or in any of the upper limbs, except shoulders, if less than a year has passed since the episode.
• History of surgical intervention in any of the shoulders.
• Tumor growth in the shoulder region.
• Neuromuscular injuries with shoulder muscles motor involvement (myasthenia, spinal cord injury, spastic contracture, paresis).
• Inflammatory diseases (rheumatoid arthritis, psoriatic arthritis) affecting the shoulder region in state of outbreak.
• Metabolic or systemic diseases with potential to modify tissue elastic capacity.
• Diseases or injuries with contraindication to mobilization or physical exercise of the shoulder region.
• Inability to perform the stretch due to pain.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Departamento de Enfermería y Fisioterapia

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (14)

• Jacome-Lopez R, Tejada-Gallego J, Silberberg JM, Garcia-Sanz F, Garcia-Muro-San Jose F. Glenohumeral internal rotation deficit in general population with shoulder pain: A descriptive observational study. Medicine (Baltimore). 2023 Dec 15;102(50):e36551. doi: 10.1097/MD.0000000000036551.

  PMID: 38115341 BACKGROUND

• Rosa DP, Borstad JD, Ferreira JK, Gava V, Santos RV, Camargo PR. Comparison of specific and non-specific treatment approaches for individuals with posterior capsule tightness and shoulder impingement symptoms: A randomized controlled trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):648-658. doi: 10.1016/j.bjpt.2021.04.003. Epub 2021 May 4.

  PMID: 34001426 BACKGROUND

• Borstad JD, Dashottar A. Quantifying strain on posterior shoulder tissues during 5 simulated clinical tests: a cadaver study. J Orthop Sports Phys Ther. 2011 Feb;41(2):90-9. doi: 10.2519/jospt.2011.3357. Epub 2010 Nov 10.

  PMID: 21169717 BACKGROUND

• Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.

  PMID: 18668168 BACKGROUND

• Wilk KE, Hooks TR, Macrina LC. The modified sleeper stretch and modified cross-body stretch to increase shoulder internal rotation range of motion in the overhead throwing athlete. J Orthop Sports Phys Ther. 2013 Dec;43(12):891-4. doi: 10.2519/jospt.2013.4990. Epub 2013 Oct 30.

  PMID: 24175603 BACKGROUND

• Mine 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.

  PMID: 27632891 BACKGROUND

• Izumi T, Aoki M, Muraki T, Hidaka E, Miyamoto S. Stretching positions for the posterior capsule of the glenohumeral joint: strain measurement using cadaver specimens. Am J Sports Med. 2008 Oct;36(10):2014-22. doi: 10.1177/0363546508318196. Epub 2008 Jun 20.

  PMID: 18567716 BACKGROUND

• McClure P, Balaicuis J, Heiland D, Broersma ME, Thorndike CK, Wood A. A randomized controlled comparison of stretching procedures for posterior shoulder tightness. J Orthop Sports Phys Ther. 2007 Mar;37(3):108-14. doi: 10.2519/jospt.2007.2337.

  PMID: 17416125 BACKGROUND

• Yamauchi T, Hasegawa S, Nakamura M, Nishishita S, Yanase K, Fujita K, Umehara J, Ji X, Ibuki S, Ichihashi N. Effects of two stretching methods on shoulder range of motion and muscle stiffness in baseball players with posterior shoulder tightness: a randomized controlled trial. J Shoulder Elbow Surg. 2016 Sep;25(9):1395-403. doi: 10.1016/j.jse.2016.04.025. Epub 2016 Jul 27.

  PMID: 27475455 BACKGROUND

• Tawfik A, Toci GR, Sirch F, Gibbs B, Conte E, Fletcher D, Hornstein J, Aland C. The Effects of Sleeper and Superman Stretches on Time-Zero Shoulder Range of Motion in Collegiate Athletes. Cureus. 2022 Feb 25;14(2):e22600. doi: 10.7759/cureus.22600. eCollection 2022 Feb.

  PMID: 35371739 BACKGROUND

• Chepeha JC, Magee DJ, Bouliane M, Sheps D, Beaupre L. Effectiveness of a Posterior Shoulder Stretching Program on University-Level Overhead Athletes: Randomized Controlled Trial. Clin J Sport Med. 2018 Mar;28(2):146-152. doi: 10.1097/JSM.0000000000000434.

  PMID: 28731885 BACKGROUND

• Takenaga T, Sugimoto K, Goto H, Nozaki M, Fukuyoshi M, Tsuchiya A, Murase A, Ono T, Otsuka T. Posterior Shoulder Capsules Are Thicker and Stiffer in the Throwing Shoulders of Healthy College Baseball Players: A Quantitative Assessment Using Shear-Wave Ultrasound Elastography. Am J Sports Med. 2015 Dec;43(12):2935-42. doi: 10.1177/0363546515608476. Epub 2015 Oct 15.

  PMID: 26473012 BACKGROUND

• Iida N, Taniguchi K, Watanabe K, Miyamoto H, Taniguchi T, Fujimiya M, Katayose M. Relationship between shear modulus and passive tension of the posterior shoulder capsule using ultrasound shear wave elastography: A cadaveric study. J Biomech. 2020 Jan 23;99:109498. doi: 10.1016/j.jbiomech.2019.109498. Epub 2019 Nov 9.

  PMID: 31735360 BACKGROUND

• Iida N, Taniguchi K, Watanabe K, Miyamoto H, Taniguchi T, Teramoto A, Katayose M. Effective stretching positions for the posterior shoulder capsule as determined by shear wave elastography. J Shoulder Elbow Surg. 2021 May;30(5):1186-1195. doi: 10.1016/j.jse.2020.08.021. Epub 2020 Sep 9.

  PMID: 32919046 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esteban Ramirez-Llano, PT

  Member of the department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esteban Ramirez-Llano, PT

CONTACT

+34 635221898; esteban.ramirez@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: The same intervention, a programme of the Modified Sleeper-Stretch, will be applied on two different groups

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 19, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)