Clinical trial NCT06766734: The Effect of Ultrasound-Guided Tendon Dry Needling on Pain and Function in Rotator Cuff Tendinopathy
Official title: The Effect of Ultrasound-Guided Tendon Dry Needling on Pain and Function Added to Therapeutic Ultrasound Therapy in Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraspinatus Tendinopathy
Keywords: Exercise, Supraspinatus tendinopathy, tendinosis, partial tear, dry needling, therapeutic ultrasound, ultrasonography
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-09
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized into 2 groups as a tendon dry needling group or sham tendon dry needling group
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to observe the effect of adding dry needling to therapeutic ultrasound treatment on pain and function in patients with supraspinatus tendinopathy.

Detailed description: One of the common causes of shoulder pain is rotator cuff tendinopathy (RCT). The most affected tendon in RCT is the supraspinatus tendon.

In supraspinatus tendinopathy (SST) various treatment methods are attempted. Conservative treatments are the first-line approach for SST. These include non-steroidal anti-inflammatory drugs (NSAIDs), hot and cold applications, exercise, manual therapy, therapeutic ultrasound (US) therapy, and subacromial steroid injections. Additionally, treatments such as subacromial platelet-rich plasma (PRP) and prolotherapy have been developed. Surgically, rotator cuff repair or subacromial decompression can be performed. Conservative methods can be effective in reducing pain and improving function. While half of shoulder pain cases resolve within 2-3 months, pain persists for more than 12 months in the other half. When we look at the literature, unfortunately there is no gold standard treatment method for SST. Although tendon dry needling is a new treatment method in the treatment of tendinopathy, there are a few articles in the literature about tendon dry needling.

In this study the demographic data (age, gender, occupation (excessive shoulder use (yes/no)), painful shoulder (right, left), dominant hand (right, left), height, weight, body mass index, duration of pain) of the patients who will participate in the study were recorded. Patients were randomized into 2 groups using a closed-envelope method. The first group received DN twice at 4-week intervals under ultrasound guidance (USG) to the supraspinatus tendon, while the second group received placebo DN to a similar anatomical area by randomly positioning the probe. Both groups underwent a total of 15 sessions of US therapy, 5 times a week for 3 weeks, combined with an exercise program. Tendon DN was performed under sterile conditions using an Esaote MylabFive device with a 5-12 MHz superficial probe for real-time imaging in our clinic. To reduce shoulder pain associated with the procedure, 1 ml of 1% prilocaine was injected before the application. A 0.25x40 mm needle was used for DN. In patients who reported pain reduction, the supraspinatus tendon was scanned from front to back, and DN was applied to the detected lesion area. Patients were allowed to continue daily activities, excluding overhead movements, for two weeks. Range of motion (ROM) and Codman shoulder exercises started the day after the injection. Both groups were given progressive resistance supraspinatus strengthening exercises within the pain threshold along with ROM and Codman exercises during the US therapy period. Patient assessments were conducted before treatment, at 1 month (after 15 sessions of therapeutic US treatment and before the 2nd DN), and at 3 months. Patient evaluation parameters included the Visual Analog Scale (VAS) for pain, the Simple Shoulder Test (SST) for function, and SPADI (Shoulder Pain and Disability Index). The evaluator was kept blinded to the treatments provided.

Eligibility criteria: Inclusion Criteria:

* Patients with at least 6 months of shoulder pain who presented to the outpatient clinic of the Physical Medicine and Rehabilitation Department at SBU Istanbul Training and Research Hospital who agreed to participate in the study.
* Positive examination tests (painful arc, Neer's, Hawkins-Kennedy, Yergason, Speed)
* Positive findings on MRI (tendinosis/partial rupture),

Exclusion Criteria:

* Diagnosis of rheumatologic diseases
* History of intra-articular/subacromial shoulder injection in the last 3 months
* Individuals with a history of shoulder trauma
* Individuals with a history of coronary artery disease
* Cervical origin pain
* Patients with a history of shoulder surgery
* Patients with positive tests for instability
* Patients with a history of humeral fracture
* Diabetes mellitus (DM)
* Patients with adhesive capsulitis
* Individuals allergic to local anesthetic medications
* Full-thickness rotator cuff tear

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before treatment, first month, third month
Secondary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: Before treatment, first month, third month
measure: Simple Shoulder Test
timeFrame: Before treatment, first month, third month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Fatih
Study officials:
References: