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CompletedNCT07817433Updated Sep 14, 2026

Comparison of Triamcinolone Injection and TENS for Long Head of the Biceps Tendinopathy

An interventional study of Transcutaneous Electrical Nerve Stimulation (TENS) and Triamcinolone Acetonide and Lidocaine Hydrochloride in Long Head of Biceps Brachii Tendinopathy, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years to 74 Years
Sex
All
01

Study 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. Pain, shoulder-related pain and disability, ultrasonographic findings, and clinical test results were assessed at baseline and at 1 and 3 months after treatment.

02

Conditions studied

  • Long Head of Biceps Brachii Tendinopathy
03

Who can participate

Ages eligible
19 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    TENS Group

    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.

    Device: Transcutaneous Electrical Nerve Stimulation (TENS)

  • Experimental
    Ultrasound-Guided Triamcinolone Injection

    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.

    Drug: Triamcinolone Acetonide and Lidocaine Hydrochloride

Interventions

  • DeviceTranscutaneous 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.

  • DrugTriamcinolone Acetonide and Lidocaine Hydrochloride

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months

  2. 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).

    Time frame: Baseline, 1 month, and 3 months

  3. 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.

    Time frame: Baseline, 1 month, and 3 months

  4. 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.

    Time frame: Baseline, 1 month, and 3 months

  5. 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.

    Time frame: Baseline, 1 month, and 3 months

  6. 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.

    Time frame: Baseline, 1 month, and 3 months

06

Study locations

1 site
  • Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
    Ankara, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07817433
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Yasin Demir (Professor, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Sep 14, 2026
Start date
Jan 6, 2025
Primary completion
Feb 11, 2026
Completion
Feb 11, 2026
Last update
Sep 14, 2026

Study contacts

Yasin Demir, MD
principal investigator · University of Health Sciences Türkiye, Gülhane Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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