NCT07025668

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 5, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

biceps brachiitendinopathytendon cross-sectional areashoulder pain

Outcome Measures

Primary Outcomes (1)

  • Tendon Cross-Sectional Area

    Ultrasound will be used to measure tendon cross-sectional area.

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Visual Analog Scale (VAS)

    Baseline and 12 weeks

Study Arms (3)

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.

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.

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.

Other: Control Group Exercise

Interventions

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.

Eccentric Exercise Group

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.

Combined-Exercise Group

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.

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18703976BACKGROUND
  • Ahrens 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.

    PMID: 17785735BACKGROUND
  • Chen 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.

    PMID: 30059449BACKGROUND
  • Ryu 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.

    PMID: 20226316BACKGROUND

MeSH Terms

Conditions

TendinopathyShoulder Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesArthralgiaJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ebru G SEZİK, Msc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru G SEZİK, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants in all three groups performed the given exercises without knowing which group they were included in. Outcome assessments will be performed by an investigator who was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 17, 2025

Study Start

May 9, 2025

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations