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

NCT06766734 | Completed

• 1 other identifier: IstanbulTRH-FTR-BB-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Tendinopathy

Keywords

Exercise, Supraspinatus tendinopathy, tendinosis, partial tear, dry needling, therapeutic ultrasound, ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Shoulder Pain and Disability Index

  Before treatment, first month, third month

• Simple Shoulder Test

  Before treatment, first month, third month

Study Arms (2)

Tendon Dry Needling Group

ACTIVE COMPARATOR

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

Sham Tendon Dry Needling Group

SHAM COMPARATOR

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

Interventions

Tendon Dry Needling PROCEDURE

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.

Tendon Dry Needling Group

Sham Tendon Dry Needling PROCEDURE

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.

Sham Tendon Dry Needling Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Tendinopathy

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Model Details: Participants were randomized into 2 groups as a tendon dry needling group or sham tendon dry needling group

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: November 10, 2023
• Primary Completion: August 10, 2024
• Study Completion: November 4, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)