NCT07030972

Brief Summary

Bicipital tendinitis is a condition caused by inflammation of the biceps tendon, resulting in pain and limited movement in the front of the shoulder. This condition usually develops due to repetitive shoulder movements or overuse and can negatively affect daily life. Treatment usually involves medications, cold applications, rest, and exercises. However, in some cases, these methods may not be sufficient. This study aims to investigate the effects of deep friction massage (DFM) when applied in addition to a standard exercise program. DFM is a massage technique that supports tissue healing, reduces pain, and improves mobility. Within the scope of the study, the effects of DFM combined with exercise on pain, functional capacity, fear of movement (kinesiophobia), and quality of life will be evaluated. The findings obtained aim to contribute to the development of more effective approaches in the treatment of biceps tendinitis.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Dec 2024May 2026

Study Start

First participant enrolled

December 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

June 12, 2025

Last Update Submit

April 26, 2026

Conditions

Keywords

bicipital tendinitisdeep friction massage

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

    The Visual Analog Scale (VAS) will be used to determine the intensity of pain and to compare the pain felt before and after treatment (baseline, 6th week and 12th week). VAS is a reliable and easily applicable test used to measure values that cannot be easily measured numerically by converting them into a numerical format. The lowest and highest definitions of the parameters to be evaluated are written on both ends of a 100 mm line. The patient is asked to mark the most appropriate value (location) between these two extreme points. When this scale is used for pain, the numbers "0" are written on one end to indicate no pain and "10" are written on the other end to indicate the most severe pain, and this is converted into a template, numbers between 0-10 are placed on the line and the patient is asked to choose the closest number.

    before-after treatment (baseline, 6th week and 12th week)

Secondary Outcomes (1)

  • Assessment of Functional Capacity

    before and after treatment (at baseline, 6 weeks, and 12 weeks)

Other Outcomes (3)

  • Assessment of Normal Joint Movement

    pre- and post-treatment (baseline, 6 weeks, and 12 weeks)

  • Evaluation of Kinesiophobia

    before and after treatment (at baseline, week 6, and week 12)

  • Assessment of Quality of Life

    before and after treatment (at baseline, week 6, and week 12)

Study Arms (2)

Control

ACTIVE COMPARATOR

Individuals in the control groups will be included in a routine exercise program. This exercise program will include shoulder joint range of motion exercises, finger ladder, Codman, and stick exercises, which will be applied to maintain functional range of motion in the early stages and increase it in the later stages. Isometric exercises will be applied to the scapular muscles to maintain muscle strength in the early stages. In the later stages, rotator cuff, scapular stabilizer, and deltoid strengthening exercises will be demonstrated and applied. Low-resistance therabands will be used for strengthening at the beginning. Additionally, neuromuscular control exercises and proprioceptive exercises will be included in the treatment to enhance joint stabilization and coordination. The exercises will be performed over a 6-week period, 3 days per week, with 10-30 repetitions.

Other: Exercise

Intervention group

EXPERIMENTAL

Individuals in the intervention group will receive deep friction massage on the biceps tendon in addition to the routine exercise program and following the exercise program. The individual will be placed in a long sitting position with their back supported. While the patient's shoulder is next to the body and the elbow is flexed at 90 degrees, the therapist's thumb will be placed on the painful area on the extension of the biceps tendon fibers and a deep friction massage will be applied to the point where the tendonitis occurs in a transverse direction for 3-10 minutes.

Other: ExerciseOther: Deep friction massage

Interventions

Individuals in the control and intervention groups will be included in a routine exercise program. For this exercise program; shoulder joint range of motion exercises, finger ladder, Codman and stick exercises will be given to protect functional range of motion in the early stages and to increase it in the later stages. Isometric exercises will be performed on the scapular muscles in the early stages to preserve muscle strength. In the later stages, rotator cuff, scapula stabilizers and deltoid strengthening exercises will be shown and applied, initially with low-resistance therabants for strengthening. In addition, neuromuscular control exercises and proprioceptive exercises will be included in the treatment to increase joint stabilization and coordination. Exercises will be performed for 6 weeks, 3 days a week, with 10-30 repetitions.

ControlIntervention group

Individuals in the intervention group will receive a deep friction massage to the biceps tendon after the exercise program. The individual will be placed in a long sitting position with their back supported. While the patient's shoulder is next to the body and the elbow is flexed at 90 degrees, the therapist's thumb will be placed on the painful area on the extension of the biceps tendon fibers and a deep friction massage will be applied to the point where the tendonitis occurs in a transverse direction for 3-10 minutes.

Intervention group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of bicipital tendinitis (tendinosis)
  • Be between 20 and 55 years of age
  • Have shoulder pain lasting longer than 3 months

You may not qualify if:

  • Shoulder impingement or frozen shoulder
  • Another shoulder problem such as a full-thickness rotator cuff tear or instability
  • Having received physical therapy or manual therapy for the same shoulder within the past year
  • History of upper extremity fracture
  • History of shoulder surgery
  • Presence of entrapment neuropathy
  • Having radicular pain originating from the cervical vertebrae
  • Having a systemic musculoskeletal disease
  • Having mental and cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat Üniversitesi

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (1)

  • Bozgeyik S, Kinikli GI, Topal Y, Beydagi MG, Turhan E, Kilinc HE, Guney-Deniz H. Supervised exercises have superior effects compared to home-based exercises for patients with knee osteoarthritis following platelet-rich plasma injection. Res Sports Med. 2024 Mar-Apr;32(2):279-289. doi: 10.1080/15438627.2022.2102920. Epub 2022 Jul 19.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The type of the research is a parallel randomized controlled trial with before-after measurements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

December 20, 2024

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to the small sample size and ethical restrictions regarding patient confidentiality in this single-center study, individual participant data will not be publicly shared. However, aggregated data will be available upon reasonable request.

Locations