NCT06241404

Brief Summary

Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause. the most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact. quality of life, leading to a major socio-economic impact. As a result, there are two treatment approaches with potential effectiveness: therapeutic exercise (TE) and myofascial trigger point treatment (TMT). trigger point treatment (TTP). Objective: The main objective of this randomised clinical trial is to determine the efficacy of ET versus treatment of MTPs in shoulder tendinopathies. Methods: For this study, 20 participants were randomly divided into two groups: a ET group, with which a 10-exercise programme was initiated (n = 10), and a PGM group which was given an intervention protocol (n = 10). intervention protocol (n = 10). Both received a total of 10 sessions. Pain intensity pain intensity, pressure pain threshold (PPT) and range of motion (ROM) were assessed before starting and after 10 sessions. and after 10 sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

January 25, 2024

Last Update Submit

February 2, 2024

Conditions

Keywords

shoulder tendinopathysupraspinatusinfraspinatusphysiotherapy techniquestherapeutic exercisetrigger points

Outcome Measures

Primary Outcomes (2)

  • Range of motion

    measurement of shoulder range of motion

    At the end of Session 10 (each Session is 7 days)

  • pain intensity

    measured on a VAS scale where 0 is the minimum and 10 is the maximum.

    At the end of Session 10 (each Session is 7 days)

Secondary Outcomes (1)

  • pressure pain threshold

    At the end of Session 10 (each Session is 7 days)

Study Arms (2)

therapeutic exercise group

EXPERIMENTAL

patients who have been treated for shoulder tendinopathy by exercise therapy

Procedure: Exercise therapy

trigger points group

ACTIVE COMPARATOR

patients who have been treated for shoulder tendinopathy by trigger point therapy

Procedure: trigger point therapy

Interventions

patients who have been treated for shoulder tendinopathy by trigger point therapy

trigger points group

patients who have been treated for shoulder tendinopathy by exercise therapy

therapeutic exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent form.
  • Patients diagnosed by an orthopaedic surgeon with shoulder tendinopathy. tendinopathy.
  • Symptoms of shoulder pain lasting more than 3 months.
  • Pain on Jobe, Patte and infraspinatus assessment manoeuvres (highlighting abduction and abduction and external rotation).

You may not qualify if:

  • Previous shoulder surgery.
  • Radiating (non-referred) pain from cervical radiculopathy.
  • Shoulder pain associated with other diagnoses (Examples: retractile capsulitis, subacromial syndrome, tendon rupture, posterosuperior conflict, etc.).
  • subacromial syndrome, tendon rupture, posterosuperior conflict, etc).
  • Patients with multiple pathologies.
  • Patients with neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorge Velázquez Saornil

Ávila, 05001, Spain

Location

Related Publications (8)

  • Yoma M, Herrington L, Mackenzie TA. The Effect of Exercise Therapy Interventions on Shoulder Pain and Musculoskeletal Risk Factors for Shoulder Pain in Competitive Swimmers: A Scoping Review. J Sport Rehabil. 2022 Feb 23;31(5):617-628. doi: 10.1123/jsr.2021-0403. Print 2022 Jul 1.

    PMID: 35196648BACKGROUND
  • Jung KM, Choi JD. The Effects of Active Shoulder Exercise with a Sling Suspension System on Shoulder Subluxation, Proprioception, and Upper Extremity Function in Patients with Acute Stroke. Med Sci Monit. 2019 Jun 30;25:4849-4855. doi: 10.12659/MSM.915277.

    PMID: 31256191BACKGROUND
  • Spanhove V, De Wandele I, Malfait F, Calders P, Cools A. Home-based exercise therapy for treating shoulder instability in patients with hypermobile Ehlers-Danlos syndrome/hypermobility spectrum disorders. A randomized trial. Disabil Rehabil. 2023 Jun;45(11):1811-1821. doi: 10.1080/09638288.2022.2076932. Epub 2022 May 24.

    PMID: 35609204BACKGROUND
  • Richmond H, Lait C, Srikesavan C, Williamson E, Moser J, Newman M, Betteley L, Fordham B, Rees S, Lamb SE, Bruce J; PROSPER Study Group. Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER). BMC Health Serv Res. 2018 Jun 18;18(1):463. doi: 10.1186/s12913-018-3280-x.

    PMID: 29914494BACKGROUND
  • Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.

    PMID: 28714658BACKGROUND
  • Fathollahnejad K, Letafatkar A, Hadadnezhad M. The effect of manual therapy and stabilizing exercises on forward head and rounded shoulder postures: a six-week intervention with a one-month follow-up study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):86. doi: 10.1186/s12891-019-2438-y.

  • Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.

  • Villa Munoz T, Velazquez Saornil J, Sanchez Mila Z, Romero-Morales C, Almazan Polo J, Baraja Vegas L, Hugo-Villafane J, Abuin-Porras V. Comparative evaluation of the efficacy of therapeutic exercise versus myofascial trigger point therapy in the treatment of shoulder tendinopathies: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 16;10(4):e002043. doi: 10.1136/bmjsem-2024-002043. eCollection 2024.

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 5, 2024

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

January 15, 2024

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations