- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241404
Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points.
Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points in Shoulder Tendinopathies: Randomised Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ávila, Spain, 05001
- Jorge Velázquez Saornil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: therapeutic exercise group
patients who have been treated for shoulder tendinopathy by exercise therapy
|
patients who have been treated for shoulder tendinopathy by exercise therapy
|
|
Active Comparator: trigger points group
patients who have been treated for shoulder tendinopathy by trigger point therapy
|
patients who have been treated for shoulder tendinopathy by trigger point therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: At the end of Session 10 (each Session is 7 days)
|
measurement of shoulder range of motion
|
At the end of Session 10 (each Session is 7 days)
|
|
pain intensity
Time Frame: At the end of Session 10 (each Session is 7 days)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain threshold
Time Frame: At the end of Session 10 (each Session is 7 days)
|
measured by algometer
|
At the end of Session 10 (each Session is 7 days)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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