Long Head of Biceps Brachii TendinopathyNCT07817433
Comparison of Triamcinolone Injection and TENS for Long Head of the Biceps Tendinopathy
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Triamcinolone Acetonide and Lidocaine Hydrochloride in people with Long Head of Biceps Brachii Tendinopathy, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial compared ultrasound-guided triamcinolone injection and transcutaneous electrical nerve stimulation (TENS) in patients with long head of the biceps brachii tendinopathy. Participants in both groups also received a supervised physiotherapy exercise program. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Long Head of Biceps Brachii Tendinopathy
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Triamcinolone Acetonide and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 11 Feb 2026
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and <75 years.
- Provision of written informed consent.
- Long head of the biceps brachii tendinopathy confirmed by ultrasonography (USG) or magnetic resonance imaging (MRI).
- Shoulder pain lasting longer than 1 month.
- Failure of previous medical treatment.
Who cannot join
- Long head of the biceps brachii tendon rupture confirmed by ultrasonography (USG) or magnetic resonance imaging (MRI).
- Wound and/or infection at the intervention site.
- Steroid injection for the same diagnosis within the previous 3 months.
- Known allergy to triamcinolone and/or lidocaine.
- Sensory impairment in the shoulder or upper extremity.
- Uncontrolled diabetes mellitus.
- Diagnosis of epilepsy.
- Full-thickness rotator cuff tear confirmed by ultrasonography (USG) or magnetic resonance imaging (MRI).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara
About this study
Official title: Comparison of Ultrasound-Guided Triamcinolone Injection and Transcutaneous Electrical Nerve Stimulation for the Treatment of Long Head of the Biceps Brachii Tendinopathy
This randomized clinical trial compared ultrasound-guided triamcinolone injection and transcutaneous electrical nerve stimulation (TENS) in patients with long head of the biceps brachii tendinopathy. Participants in both groups also received a supervised physiotherapy exercise program. Pain, shoulder-related pain and disability, ultrasonographic findings, and clinical test results were assessed at baseline and at 1 and 3 months after treatment.
- Conditions
- Long Head of Biceps Brachii Tendinopathy
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Triamcinolone Acetonide and Lidocaine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Conventional transcutaneous electrical nerve stimulation (TENS) was applied at a frequency of 200 Hz and a pulse duration of 200 μs for 15 minutes per session, for a total of 15 sessions.
Triamcinolone Acetonide and Lidocaine HydrochlorideDrug
A single ultrasound-guided peritendinous injection of 1 mL triamcinolone acetonide (40 mg/mL) mixed with 1 mL lidocaine hydrochloride (20 mg/mL) was administered around the long head of the biceps tendon.
| Study group | Role | What they receive |
|---|---|---|
| TENS Group | Active comparator | Participants received conventional transcutaneous electrical nerve stimulation (TENS) for 15 sessions, 15 minutes per session, using a frequency of 200 Hz and a pulse duration of 200 μs. After each TENS session, participants underwent a physiotherapist-supervised exercise program consisting of range-of-motion, stretching, and progressive strengthening exercises. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Ultrasound-Guided Triamcinolone Injection | Experimental | Participants received a single ultrasound-guided peritendinous injection of 1 mL triamcinolone acetonide (40 mg/mL) mixed with 1 mL lidocaine hydrochloride (20 mg/mL) around the long head of the biceps tendon. Immediately after the injection, participants began a physiotherapist-supervised exercise program consisting of range-of-motion, stretching, and progressive strengthening exercises. Receives: Drug: Triamcinolone Acetonide and Lidocaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Pain
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS). Pain was evaluated both at rest and during movement. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (6)
Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI), which includes pain and disability subscales. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability.
Measured: Baseline, 1 month, and 3 months
Maximum diameter of the long head of the biceps tendon
The maximum diameter of the long head of the biceps brachii tendon was measured by musculoskeletal ultrasonography at the site of greatest tendon thickness and recorded in millimeters (mm).
Measured: Baseline, 1 month, and 3 months
Peritendinous fluid around the long head of the biceps tendon
Peritendinous fluid was measured by ultrasonography at the site of greatest effusion between the tendon and tendon sheath and recorded in millimeters (mm). Minimal probe compression was applied during measurement.
Measured: Baseline, 1 month, and 3 months
Increased vascular signal in the long head of the biceps tendon
Vascular signal in the long head of the biceps tendon region was assessed using Doppler ultrasonography. Any increase in vascular signal detected along the bicipital groove was considered positive. The result was recorded as positive or negative.
Measured: Baseline, 1 month, and 3 months
Speed Test
The Speed test was used to evaluate pathology of the long head of the biceps tendon. Test results were recorded as positive or negative.
Measured: Baseline, 1 month, and 3 months
Yergason Test
The Yergason test was used to evaluate pathology of the long head of the biceps tendon. Test results were recorded as positive or negative.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start6 Jan 2025
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Head of Biceps Brachii 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Yasin Demir, MD, Principal investigator, University of Health Sciences Türkiye, Gülhane Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817433
- Sponsor's protocol ID
- E2-24-9177
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Triamcinolone Injection and Transcutaneous Electrical Nerve Stimulation for the Treatment of Long Head of the Biceps Brachii Tendinopathy
- ClinicalTrials.gov ID
- NCT07817433
- Acronym / sponsor ID
- E2-24-9177
- Conditions
- Long Head of Biceps Brachii Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 14 Sep 2026 (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.
This randomized clinical trial compared ultrasound-guided triamcinolone injection and transcutaneous electrical nerve stimulation (TENS) in patients with long head of the biceps brachii tendinopathy. Participants in both groups also received a supervised physiotherapy exercise program. Pain, shoulder-related pain and disability, ultrasonographic findings, and clinical test results were assessed at baseline and at 1 and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants received conventional transcutaneous electrical nerve stimulation (TENS) for 15 sessions, 15 minutes per session, using a frequency of 200 Hz and a pulse duration of 200 μs. After each TENS session, participants underwent a physiotherapist-supervised exercise program consisting of range-of-motion, stretching, and progressive strengthening exercises. |
| Ultrasound-Guided Triamcinolone Injection | Experimental | Drug: Triamcinolone Acetonide and Lidocaine HydrochlorideParticipants received a single ultrasound-guided peritendinous injection of 1 mL triamcinolone acetonide (40 mg/mL) mixed with 1 mL lidocaine hydrochloride (20 mg/mL) around the long head of the biceps tendon. Immediately after the injection, participants began a physiotherapist-supervised exercise program consisting of range-of-motion, stretching, and progressive strengthening exercises. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years and <75 years.
- Provision of written informed consent.
- Long head of the biceps brachii tendinopathy confirmed by ultrasonography (USG) or magnetic resonance imaging (MRI).
- Shoulder pain lasting longer than 1 month.
- Failure of previous medical treatment.
Key exclusion criteria (8 listed)
- Long head of the biceps brachii tendon rupture confirmed by ultrasonography (USG) or magnetic resonance imaging (MRI).
- Wound and/or infection at the intervention site.
- Steroid injection for the same diagnosis within the previous 3 months.
- Known allergy to triamcinolone and/or lidocaine.
- Sensory impairment in the shoulder or upper extremity.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Conventional transcutaneous electrical nerve stimulation (TENS) was applied at a frequency of 200 Hz and a pulse duration of 200 μs for 15 minutes per session, for a total of 15 sessions. | Device | TENS Group |
| Triamcinolone Acetonide and Lidocaine HydrochlorideA single ultrasound-guided peritendinous injection of 1 mL triamcinolone acetonide (40 mg/mL) mixed with 1 mL lidocaine hydrochloride (20 mg/mL) was administered around the long head of the biceps tendon. | Drug | Ultrasound-Guided Triamcinolone Injection |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: Baseline, 1 month, and 3 months
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS). Pain was evaluated both at rest and during movement. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
6 secondary outcomes
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline, 1 month, and 3 months
Maximum diameter of the long head of the biceps tendon
Time frame: Baseline, 1 month, and 3 months
Peritendinous fluid around the long head of the biceps tendon
Time frame: Baseline, 1 month, and 3 months
Increased vascular signal in the long head of the biceps tendon
Time frame: Baseline, 1 month, and 3 months
Speed Test
Time frame: Baseline, 1 month, and 3 months
Yergason Test
Time frame: Baseline, 1 month, and 3 months
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Yasin Demir, MD principal investigator
University of Health Sciences Türkiye, Gülhane Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Triamcinolone Acetonide and Lidocaine Hydrochloride in people with Long Head of Biceps Brachii Tendinopathy, run by Gaziler Physical Medicine and Rehabilitation Education 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 5 inclusion and 8 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 14 Sep 2026. 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. 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 (VAS) for Pain (time frame: Baseline, 1 month, and 3 months). 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 14 Sep 2026.