Sports Physical TherapyNCT07025668
The Effectiveness of Different Exercise Approaches in Biceps Brachii Long Head Tendinopathy
A study testing Eccentric Exercise and Combined Exercise in people with Sports Physical Therapy and Tendinopathy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to analyze the changes in tendon cross-sectional area and shoulder pain with different exercise approaches applied in biceps brachii long head tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sports Physical Therapy, Tendinopathy
- What is being tested?
- Eccentric Exercise and Combined Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having shoulder pain lasting 3 months or more
- Without a history of surgery, having a diagnosis of shoulder rotator cuff tendinopathy, rotator cuff stage 1-2 tear or subacromial impingement, and having been diagnosed with secondary biceps long head tendinopathy by a physician
- Pain level during activity > 3 according to the visual analog scale
- Patients who have been informed about the study and have given written consent to participate in the study will be included in the study.
Who cannot join
- Acute shoulder injury
- History of shoulder and cervical surgery
- Limitation of passive range of motion
- History of local corticosteroid injection within the last 12 months
- Patients who cannot comply with the exercise program will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
Ebru G SEZİK, Msc, 05532025875, ebrugulozdemiir@gmail.com
About this study
Official title: Effects of Different Exercise Approaches on Tendon Cross-sectional Area and Pain in Biceps Brachii Long Head Tendinopathy
This study was planned to analyze the changes in tendon cross-sectional area and shoulder pain with different exercise approaches applied in biceps brachii long head tendinopathy.
Read the detailed description
There are different conservative treatment options for biceps brachii long head tendinopathy. However, the exercise approaches that can be applied for biceps brachii tendinopathy are not clear in the literature. This study aims to investigate the effectiveness of exercises that include 12 weeks of eccentric training or combined exercise approaches.
- Conditions
- Sports Physical Therapy, Tendinopathy
- Being tested
- Eccentric Exercise, Combined Exercise, Control Group Exercise
- Keywords
- biceps brachii, tendinopathy, tendon cross-sectional area, shoulder pain
- Medical subject headings
- Tendinopathy, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric ExerciseOther
In the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.
Combined ExerciseOther
In the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.
Control Group ExerciseOther
In the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Exercise Group | Active comparator | In the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given. Receives: Other: Eccentric Exercise |
| Combined-Exercise Group | Active comparator | In the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle. Receives: Other: Combined Exercise |
| Control Group | Active comparator | In the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group. Receives: Other: Control Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon Cross-Sectional Area
Ultrasound will be used to measure tendon cross-sectional area.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Visual Analog Scale (VAS)
The patient will be asked to mark the severity of his/her pain at rest, at night, and during general activity on a 10 cm line without numbers, and the point they mark will be measured in millimeters with a ruler. The left end of the line indicates no pain, corresponding to 0 cm, while the pain level increases towards the right end of the line, which is marked at 10 cm.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start9 May 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- three groups with a conventional therapy control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Gül SEZİK, Hacettepe University
- Investigators
- Ebru G SEZİK, Msc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025668
- Sponsor's protocol ID
- BisepsLongHead
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman DJ, Dunn JC, Higgins LD, Warner JJ. Proximal biceps tendon: injuries and management. Sports Med Arthrosc Rev. 2008 Sep;16(3):162-9. doi: 10.1097/JSA.0b013e318184f549.
PubMed 18703976Ahrens PM, Boileau P. The long head of biceps and associated tendinopathy. J Bone Joint Surg Br. 2007 Aug;89(8):1001-9. doi: 10.1302/0301-620X.89B8.19278.
PubMed 17785735Chen RE, Voloshin I. Long Head of Biceps Injury: Treatment Options and Decision Making. Sports Med Arthrosc Rev. 2018 Sep;26(3):139-144. doi: 10.1097/JSA.0000000000000206.
PubMed 30059449Ryu JH, Pedowitz RA. Rehabilitation of biceps tendon disorders in athletes. Clin Sports Med. 2010 Apr;29(2):229-46, vii-viii. doi: 10.1016/j.csm.2009.12.003.
PubMed 20226316
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Exercise Approaches on Tendon Cross-sectional Area and Pain in Biceps Brachii Long Head Tendinopathy
- ClinicalTrials.gov ID
- NCT07025668
- Acronym / sponsor ID
- BisepsLongHead
- Conditions
- Sports Physical Therapy, Tendinopathy
- Keywords
- biceps brachii, tendinopathy, tendon cross-sectional area, shoulder pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Jun 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.
This study was planned to analyze the changes in tendon cross-sectional area and shoulder pain with different exercise approaches applied in biceps brachii long head tendinopathy.
Detailed description
There are different conservative treatment options for biceps brachii long head tendinopathy. However, the exercise approaches that can be applied for biceps brachii tendinopathy are not clear in the literature. This study aims to investigate the effectiveness of exercises that include 12 weeks of eccentric training or combined exercise approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Eccentric Exercise Group | Active comparator | Other: Eccentric ExerciseIn the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given. |
| Combined-Exercise Group | Active comparator | Other: Combined ExerciseIn the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle. |
| Control Group | Active comparator | Other: Control Group ExerciseIn the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having shoulder pain lasting 3 months or more
- Without a history of surgery, having a diagnosis of shoulder rotator cuff tendinopathy, rotator cuff stage 1-2 tear or subacromial impingement, and having been diagnosed with secondary biceps long head tendinopathy by a physician
- Pain level during activity > 3 according to the visual analog scale
- Patients who have been informed about the study and have given written consent to participate in the study will be included in the study.
Key exclusion criteria (5 listed)
- Acute shoulder injury
- History of shoulder and cervical surgery
- Limitation of passive range of motion
- History of local corticosteroid injection within the last 12 months
- Patients who cannot comply with the exercise program will be excluded from the study.
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 |
|---|---|---|
| Eccentric ExerciseIn the eccentric exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, eccentric strengthening exercises for the biceps brachii muscle will be given. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks. | Other | Eccentric Exercise Group |
| Combined ExerciseIn the combined exercise group, in addition to strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle, progressive isometric, isotonic and plyometric strengthening training will be given to the biceps brachii muscle. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks. | Other | Combined-Exercise Group |
| Control Group ExerciseIn the control group, strengthening exercises for the periscapular muscles and stretching exercises for the biceps brachii muscle will be given. Strengthening exercises for the biceps brachii muscle will not be given in this group. Participants will do the exercises in the groups they were randomized to every day for 12 weeks. They will be called to the clinic once a week for exercise checks. | Other | Control Group |
Primary outcome
Tendon Cross-Sectional Area
Time frame: Baseline and 12 weeks
Ultrasound will be used to measure tendon cross-sectional area.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 18703976Friedman DJ, Dunn JC, Higgins LD, Warner JJ. Proximal biceps tendon: injuries and management. Sports Med Arthrosc Rev. 2008 Sep;16(3):162-9. doi: 10.1097/JSA.0b013e318184f549.
- Background: PubMed 17785735Ahrens PM, Boileau P. The long head of biceps and associated tendinopathy. J Bone Joint Surg Br. 2007 Aug;89(8):1001-9. doi: 10.1302/0301-620X.89B8.19278.
- Background: PubMed 30059449Chen RE, Voloshin I. Long Head of Biceps Injury: Treatment Options and Decision Making. Sports Med Arthrosc Rev. 2018 Sep;26(3):139-144. doi: 10.1097/JSA.0000000000000206.
- Background: PubMed 20226316Ryu JH, Pedowitz RA. Rehabilitation of biceps tendon disorders in athletes. Clin Sports Med. 2010 Apr;29(2):229-46, vii-viii. doi: 10.1016/j.csm.2009.12.003.
- 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.
Ebru G SEZİK, Msc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercise and Combined Exercise in people with Sports Physical Therapy and Tendinopathy, run by Hacettepe University 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru G SEZİK, Msc (05532025875, ebrugulozdemiir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon Cross-Sectional Area (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025668, which also lists 4 linked publications.
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 17 Jun 2025.