An interventional study of Dry needling with and without ultrasound guidance in Tendinopathy and Rotator Cuff, sponsored by University of Alcala. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
Among 43 studies in Tendinopathy with a site in Spain — 10 open to participants now, 10 under way, none of them phase 3. Tendinopathy · Spain.
Among the 43 studies in Tendinopathy with a site in Spain, this one is the 14th largest by planned enrollment of the 40 interventional ones, is one of 3 that started in 2024, is one of 36 with no phase, and was the 28th registered.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 76 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →10 of the 43 studies in Tendinopathy with a site in Spain are open now, in 1 country. Each count lists the studies.
Of the 47 Tendinopathy studies recruiting now, 16 (34%) set no upper age limit and 24 (51%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2024.
Median enrollment 59 across the 40 interventional studies, 100 across the 3 observational. Of the 26 that completed or were terminated, 1 (4%) have results posted.
2 of 43 have an industry lead sponsor. The 10 most frequent:
University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
University of Alcala has 3 studies filed under Tendinopathy — fewer than ten, so there is no comparison to draw.
2 of the studies in Tendinopathy with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07929675DAVID CRUZ DÍAZUltrasound-Guided Percutaneous Electrolysis Plus Exercise for Chronic Supraspinatus Tendinopathy | 2027-03-01 |
| NCT06729437University of ValenciaTranscranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy | 2027-07-01 |
Among the 43 studies in Tendinopathy with a site in Spain, from their registry updates:
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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Exclusion Criteria:
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 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
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who undergo ultrasound-guided real dry needling, using the ultrasound to visualize the needle, and who follow an exercise program.
Procedure: Dry needling with and without ultrasound guidance
Patients who will undergo ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol.
Procedure: Dry needling with and without ultrasound guidance
Patients who will undergo non-ultrasound-guided dry needling on the infraspinatus muscle and will follow an established exercise protocol
Procedure: Dry needling with and without ultrasound guidance
Patients who will undergo non-ultrasound-guided placebo dry needling on the infraspinatus muscle and will follow an established exercise protocol
Procedure: Dry needling with and without ultrasound guidance
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.
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
Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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.
Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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.
Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
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.
Time frame: Before starting the treatment, at the end of the treatment, and six months after completing the treatment
Plan to share: No
Start is estimated for Sep 2024; primary completion for Feb 2025, 5 months later.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 5 months is below that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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