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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Alcala

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dry needling with and without ultrasound guidance

    Procedure/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.

Treatment groups

76 Participants
are divided into 4 treatment groups
Group A: Real ultrasound-guided dry needling on the infraspinatus muscle + exerciseActive comparator 1 intervention
Group B: Placebo ultrasound-guided dry needling on the infraspinatus muscle + exerciseSham comparator 1 intervention
Group C: Non-ultrasound-guided real dry needling on the infraspinatus muscle + exerciseActive comparator 1 intervention
Group D: Non-ultrasound-guided placebo dry needling on the infraspinatus muscle + exerciseSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Before starting the treatment, at the end of the treatment, and six months after completing the treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: