AzTrials
AzTrials

TendinopathyDN-INFR-RCTNCT06583707

Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle

A study testing Dry needling with and without ultrasound guidance in people with Tendinopathy and Rotator Cuff, run by University of Alcala at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The infraspinatus muscle is one of the four muscles that form the rotator cuff. The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Tendinopathy, Rotator Cuff
What is being tested?
Dry needling with and without ultrasound guidance
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteSpain
Study dates
23 Sep 2024to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged between 18 and 60 years. Patients diagnosed with rotator cuff tendinopathy by a physician. The physician must have determined this diagnosis based on an imaging test: ultrasound or MRI. Presence of a taut band in the infraspinatus muscle with active trigger points that reproduce the patient\'s symptoms upon pressure.
  • -

Who cannot join

  • High-level athletes, patients diagnosed with capsulitis, patients with a history of humeral or scapular fracture, patients with a complete or partial rotator cuff tear, patients diagnosed with cancer, and patients with any contraindications related to dry needling, patients who have previously undergone shoulder surgery, patients with a history of shoulder dislocation, patients diagnosed with fibromyalgia, patients taking medication for shoulder pain, and pregnant patients
  • -

Trial locations and contacts

1 site in 1 country.

Enrique Coca, Student contact

+34671136617

enrique.coca@edu.uah.es

Spain1 site
  • Campus Científico-Tecnológico UAH Av. de León, 3A

    Alcalá de Henares, Madrid, 28805

    Enrique Coca, Student, +34671136617, enrique.coca@edu.uah.es

Other trials in Spain

About this study

Official title: Effect of the Application of Real Dry Needling and Placebo Dry Needling Applied With and Without Ultrasound Guidance on the Infraspinatus Muscle in Shoulder Pain and Functionality in Patients Diagnosed With Rotator Cuff Tendinopathy

The infraspinatus muscle is one of the four muscles that form the rotator cuff. The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. This technique can be performed using ultrasound guidance, which allows us to visualize the needle at all times, but it can also be done using anatomical landmarks. This study includes a self-directed exercise plan for rotator cuff tendinopathy. Variables such as strength, shoulder functionality level, grip strength, and active range of motion will be measured. As part of the intervention, two dry needling sessions will be performed, 14 days apart, along with two different exercise programs. Three measurements will be taken, and the intervention will last for 6 weeks. The sample will be divided into four equal groups: Group 1: ultrasound-guided real dry needling; Group 2: ultrasound-guided placebo dry needling; Group 3: non-ultrasound-guided real dry needling; and Group 4: non-ultrasound-guided placebo dry needling

Read the detailed description

Pathologies affecting the rotator cuff are the most common among shoulder patho-logies. The infraspinatus muscle is one of the four muscles that make up the rotator cuff. Dry needling is a technique used to reduce pain and increase the range of motion. The ul-trasound-guided technique involves using an ultrasound device to visualize the needle and guide it to the target tissue. Physical exercise helps improve tendon recovery. Objective: To evaluate the effect of real dry needling and placebo dry needling, whether ultrasound-guided or not, on pain (VAS), shoulder functionality (SPADI questionnaire), grip strength (Jamar dynamometer), and ac-tive range of motion (electronic goniometer). A total of 76 subjects diagnosed by a physician with rotator cuff tendinopathy based on imaging, aged between 18 and 60 years, and meeting the inclusion and exclusion criteria, were divided into 4 groups: Group 1 (real ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 2 (placebo ultrasound-guided dry needling on the infraspinatus muscle + exercise), Group 3 (real non-ultrasound-guided dry needling on the infraspinatus muscle + exercise), and Group 4 (placebo non-ultrasound-guided dry needling on the infraspinatus muscle + exercise). The dry needling technique will be applied twice: at the beginning and at 14 days. The intervention duration is 6 weeks.

Being tested
Dry needling with and without ultrasound guidance
Keywords
Dry needling, Rotator cuff, Pain, Tendinopathy, ultrasound-guided, exercise
Medical subject headings
Tendinopathy, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needling with and without ultrasound guidanceProcedure or surgery

    The dry needling technique involves inserting a sterile needle to stimulate a myofascial trigger point with the aim of reducing pain and increasing range of motion and quality of life. This technique can be performed using ultrasound guidance, which allows us to visualize the needle at all times, but it can also be done using anatomical landmarks. In the placebo dry needling technique, the needle will remain stationary in the subcutaneous tissue.

Study groups in NCT06583707
Study groupRoleWhat they receive
Real ultrasound-guided dry needling on the infraspinatus muscle + exerciseActive comparatorPatients who undergo ultrasound-guided real dry needling, using the ultrasound to visualize the needle, and who follow an exercise program.
Receives: Procedure: Dry needling with and without ultrasound guidance
Placebo ultrasound-guided dry needling on the infraspinatus muscle + exerciseSham comparatorPatients who will undergo ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol.
Receives: Procedure: Dry needling with and without ultrasound guidance
Non-ultrasound-guided real dry needling on the infraspinatus muscle + exerciseActive comparatorPatients who will undergo non-ultrasound-guided dry needling on the infraspinatus muscle and will follow an established exercise protocol
Receives: Procedure: Dry needling with and without ultrasound guidance
Non-ultrasound-guided placebo dry needling on the infraspinatus muscle + exerciseSham comparatorPatients who will undergo non-ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol
Receives: Procedure: Dry needling with and without ultrasound guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain (VAS)

    To assess the pain variable, the Visual Analog Scale (VAS) will be used. This scale consists of a range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The patient autonomously selects a number from this scale based on the level of pain they feel

    Measured: Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Secondary outcomes (3)
  1. Shoulder functionality

    To assess the shoulder functionality level, the Shoulder Pain and Disability Index (SPADI) questionnaire will be used. An 8-item block of questions, which addresses the disability the person feels when performing various activities, will be used to evaluate shoulder functionality. The patient will need to respond to the questions by assigning a number between 0 and 10, where 0 indicates no difficulty performing the activity and 10 represents the maximum possible difficulty in performing the activity.

    Measured: Before starting the treatment, at the end of the treatment, and six months after completing the treatment

  2. Grip strength

    To assess the grip strength variable, grip strength will be measured through an isotonic contraction using a Jamar dynamometer. Three measurements will be taken with the affected arm, asking for a contraction of 3 to 5 seconds. The highest score of the three measurements will be the final result of the test. A well-calibrated hand dynamometer must be used for this test. Kilograms (kg) will be used as the unit of measurement.

    Measured: Before starting the treatment, at the end of the treatment, and six months after completing the treatment

  3. Active range of motion

    The variable of active range of motion in the affected upper limb will be measured for flexion, abduction, internal rotation, and external rotation using a highly reliable electronic goniometer. Three measurements of each movement will be taken, and the final value will be obtained by averaging the three measurements.

    Measured: Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start23 Sep 2024 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583707
Sponsor's protocol ID
Dry Needling Infraspinatus
Acronym
DN-INFR-RCT
Status last verified
Sep 2024
First submitted
1 Sep 2024
Last updated
4 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Serpi F, Albano D, Rapisarda S, Chianca V, Sconfienza LM, Messina C. Shoulder ultrasound: current concepts and future perspectives. J Ultrason. 2021 Jun 7;21(85):e154-e161. doi: 10.15557/JoU.2021.0025. Epub 2021 Jun 18.

    PubMed 34258041
  • de-Queiroz JHM, de-Medeiros MB, de-Lima RN, Cerdeira DQ. Exercise for rotator cuff tendinopathy. Rev Bras Med Trab. 2023 Feb 3;20(3):498-504. doi: 10.47626/1679-4435-2022-698. eCollection 2022 Jul-Sep.

    PubMed 36793454
  • Cooper K, Alexander L, Brandie D, Brown VT, Greig L, Harrison I, MacLean C, Mitchell L, Morrissey D, Moss RA, Parkinson E, Pavlova AV, Shim J, Swinton PA. Exercise therapy for tendinopathy: a mixed-methods evidence synthesis exploring feasibility, acceptability and effectiveness. Health Technol Assess. 2023 Oct;27(24):1-389. doi: 10.3310/TFWS2748.

    PubMed 37929629
  • Tahran O, Yesilyaprak SS. Effects of Modified Posterior Shoulder Stretching Exercises on Shoulder Mobility, Pain, and Dysfunction in Patients With Subacromial Impingement Syndrome. Sports Health. 2020 Mar/Apr;12(2):139-148. doi: 10.1177/1941738119900532. Epub 2020 Feb 4.

    PubMed 32017660
  • Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.

    PubMed 36922413
  • Beaudart C, Rolland Y, Cruz-Jentoft AJ, Bauer JM, Sieber C, Cooper C, Al-Daghri N, Araujo de Carvalho I, Bautmans I, Bernabei R, Bruyere O, Cesari M, Cherubini A, Dawson-Hughes B, Kanis JA, Kaufman JM, Landi F, Maggi S, McCloskey E, Petermans J, Rodriguez Manas L, Reginster JY, Roller-Wirnsberger R, Schaap LA, Uebelhart D, Rizzoli R, Fielding RA. Assessment of Muscle Function and Physical Performance in Daily Clinical Practice : A position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Calcif Tissue Int. 2019 Jul;105(1):1-14. doi: 10.1007/s00223-019-00545-w. Epub 2019 Apr 10.

    PubMed 30972475
  • Wahba MM, Selim M, Hegazy MM, Elgohary R, Abdelsalam MS. Eccentric Versus Concentric Exercises in Patients With Rheumatoid Arthritis and Rotator Cuff Tendinopathy: A Randomized Comparative Study. Ann Rehabil Med. 2023 Feb;47(1):26-35. doi: 10.5535/arm.22150. Epub 2023 Feb 15.

    PubMed 36792052
  • Dupuis F, Barrett E, Dube MO, McCreesh KM, Lewis JS, Roy JS. Cryotherapy or gradual reloading exercises in acute presentations of rotator cuff tendinopathy: a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Dec 26;4(1):e000477. doi: 10.1136/bmjsem-2018-000477. eCollection 2018.

    PubMed 30622733
  • Kinsella R, Cowan SM, Watson L, Pizzari T. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2017 Nov 14;3:45. doi: 10.1186/s40814-017-0190-3. eCollection 2017.

    PubMed 29163981
  • Roch M, Morin M, Gaudreault N. Immediate Effect of Dry Needling on the Viscoelastic Properties of a Trigger Point on the Infraspinatus Muscle Measured with MyotonPRO. Physiother Can. 2022 Jun 17;74(3):232-239. doi: 10.3138/ptc-2020-0095. eCollection 2022 Aug.

    PubMed 37325218

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling with and without ultrasound guidance in people with Tendinopathy and Rotator Cuff, run by University of Alcala at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Enrique Coca, Student (+34671136617, enrique.coca@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (VAS) (time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06583707, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in