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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Supraspinatus Tendinopathy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Tendon Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted9 Jan 2025
- Study start10 Nov 2023
- Primary completion10 Aug 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berat Bulut, Istanbul Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Tendon Dry Needling on Pain and Function Added to Therapeutic Ultrasound Therapy in Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT06766734
- Acronym / sponsor ID
- IstanbulTRH-FTR-BB-01
- Conditions
- Supraspinatus Tendinopathy
- Keywords
- Exercise, Supraspinatus tendinopathy, tendinosis, partial tear, dry needling, therapeutic ultrasound, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized into 2 groups as a tendon dry needling group or sham tendon dry needling group
| Arm | Type | Receives |
|---|---|---|
| Tendon Dry Needling Group | Active comparator | Procedure: Tendon Dry NeedlingFirst 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. |
| Sham Tendon Dry Needling Group | Sham comparator | Procedure: Sham Tendon Dry NeedlingFirst 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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),
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon Dry NeedlingTendon 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. | Procedure or surgery | Tendon Dry Needling Group |
| Sham Tendon Dry NeedlingIn 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. | Procedure or surgery | Sham Tendon Dry Needling Group |
Primary outcome
Visual Analog Scale
Time frame: Before treatment, first month, third month
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.
2 secondary outcomes
Shoulder Pain and Disability Index
Time frame: Before treatment, first month, third month
Simple Shoulder Test
Time frame: Before treatment, first month, third month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.