The Effect of Ultrasound-Guided Tendon Dry Needling on Pain and Function in Rotator Cuff Tendinopathy

The Effect of Ultrasound-Guided Tendon Dry Needling on Pain and Function Added to Therapeutic Ultrasound Therapy in Rotator Cuff Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Supraspinatus Tendinopathy
• Intervention / Treatment: Procedure: Tendon Dry Needling; Procedure: Sham Tendon Dry Needling

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34098
      • Istanbul Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tendon Dry Needling Group; First tendon dry needling was performed under sterile conditions with real-time imaging guidance using an Esaote MylabFive ultrasound device and a 5-12 MHz linear probe. Then patients were included in an exercise program combined with ultrasound (US) therapy for a total of 15 sessions, 5 times a week for 3 weeks. The second tendon dry needling procedure was performed using the same technique one month after the first tendon dry needling.	Procedure: Tendon Dry Needling; Tendon dry needling procedure is that repetitively passing the needle though the area of supraspinatus tendon. Tendon dry needling was performed under sterile conditions with real-time imaging guidance using an ultrasound probe. The supraspinatus tendon was scanned from anterior to posterior, and tendon dry needling was applied to the identified lesion (tendinozis or partial tear) area. This treatment method was applied twice, with a one-month interval between sessions.
Sham Comparator: Sham Tendon Dry Needling Group; First sham tendon dry needling was performed under sterile conditions with real-time imaging guidance using an Esaote MylabFive ultrasound device and a 5-12 MHz linear probe. Then patients were included in an exercise program combined with ultrasound (US) therapy for a total of 15 sessions, 5 times a week for 3 weeks. The second sham tendon dry needling procedure was performed using the same technique one month after the first sham tendon dry needling.	Procedure: Sham Tendon Dry Needling; In this treatment subcutaneous sham tendon dry needling was performed by randomly holding the ultrasound probe in the area corresponding to the same anatomical localization. Sham tendon dry needling performed to subcutaneus tissue not tendon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.	Before treatment, first month, third month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index	The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.	Before treatment, first month, third month
Simple Shoulder Test	Simple Shoulder Test The SST is a self-reported shoulder-specific questionnaire that measures functional limitations of the affected shoulder in patients with shoulder dysfunction.18 The SST consists of 12 questions with dichotomous (yes/ no) response options.	Before treatment, first month, third month

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): August 10, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Exercise, Supraspinatus tendinopathy, tendinosis, partial tear, dry needling, therapeutic ultrasound, ultrasonography
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: IstanbulTRH-FTR-BB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No