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Supraspinatus TendinopathyNCT06766734

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

A study testing Tendon Dry Needling in people with Supraspinatus Tendinopathy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Supraspinatus Tendinopathy
What is being tested?
Tendon Dry Needling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Nov 2023to 4 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Training and Research Hospital

    Istanbul, Fatih, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Tendon Dry Needling, Sham Tendon Dry Needling
Keywords
Exercise, Supraspinatus tendinopathy, tendinosis, partial tear, dry needling, therapeutic ultrasound, ultrasonography
Medical subject headings
Motor Activity, Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tendon Dry NeedlingProcedure or surgery

    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 Tendon Dry NeedlingProcedure or surgery

    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.

Study groups in NCT06766734
Study groupRoleWhat they receive
Tendon Dry Needling GroupActive comparatorFirst 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.
Receives: Procedure: Tendon Dry Needling
Sham Tendon Dry Needling GroupSham comparatorFirst 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.
Receives: Procedure: Sham Tendon Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Before treatment, first month, third month

Secondary outcomes (2)
  1. 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.

    Measured: Before treatment, first month, third month

  2. 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.

    Measured: Before treatment, first month, third month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start10 Nov 2023
  3. Primary completion10 Aug 2024
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomized into 2 groups as a tendon dry needling group or sham tendon dry needling group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766734
Sponsor's protocol ID
IstanbulTRH-FTR-BB-01
Status last verified
Dec 2024
First submitted
4 Jan 2025
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Tendon Dry Needling in people with Supraspinatus Tendinopathy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: Before treatment, first month, third month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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