NCT07627932

Brief Summary

This study compared three different treatment approaches for lateral epicondylitis (tennis elbow), a common condition that causes pain on the outside of the elbow.Twenty-seven patients diagnosed with lateral epicondylitis were randomly assigned to one of three treatment groups for 6 weeks:Group 1 - Blood Flow Restriction Exercise (BFRE): Patients performed wrist strengthening exercises using light weights (30% of their maximum capacity) while wearing a pressure cuff on the upper arm that partially restricted blood flow. Sessions were held twice per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 2 - Eccentric Exercise: Patients performed slow lowering (eccentric) wrist exercises using heavier weights (70% of their maximum capacity) five times per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 3 - Orthosis Only: Patients wore a wrist orthosis that held the wrist in a slightly extended position throughout the day and performed daily stretching exercises at home.The main goal was to determine whether blood flow restriction exercise could reduce pain and improve hand function more effectively than eccentric exercise or orthosis use alone. Pain levels, hand grip strength, finger pinch strength, and upper limb function were measured before and after the 6-week treatment period.The study was conducted at Dokuz Eylül University, Department of Orthopedics and Traumatology, İzmir, Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

May 21, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Lateral epicondylitisBlood flow restriction exerciseEccentric exerciseTennis elbowRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity (Visual Analog Scale)

    Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst imaginable pain." Patients marked the point corresponding to their current pain level. Change was calculated as the difference between baseline and post-treatment scores. A negative change indicates pain reduction.

    Baseline and 6 weeks

Secondary Outcomes (3)

  • Change in Hand Grip Strength

    Baseline and 6 weeks

  • Change in Pinch Strength

    Baseline and 6 weeks

  • Change in Upper Extremity Functional Disability (DASH Score)

    Baseline and 6 weeks

Study Arms (3)

Eccentric exercise

ACTIVE COMPARATOR

The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation. From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds.

Other: Eccentric Exercise

Blood flow restriction

EXPERIMENTAL

Participants in the Blood flow restriction group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks. Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry.

Other: Blood flow restriction

Orthosis

ACTIVE COMPARATOR

The orthosis group served as the reference standard conservative treatment group. Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises.

Other: Orthosis

Interventions

Participants in the BFRE group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks. Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry.

Blood flow restriction

The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation. From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds.

Eccentric exercise

The orthosis group served as the reference standard conservative treatment group. Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises.

Orthosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of lateral epicondylitis confirmed by physical examination
  • Provision of written informed consent

You may not qualify if:

  • Bilateral lateral epicondylitis
  • Cervical radiculopathy
  • History of elbow, forearm, or wrist pathology (previous elbow surgery, tendon rupture, fracture of the humerus/radius/ulna, osteoporosis, neurological involvement, or nerve paralysis)
  • Physiotherapy within the preceding 6 weeks
  • Tumor
  • Cardiac arrhythmia, pacemaker use, coagulation disorders, anticoagulant therapy, or history of deep vein thrombosis
  • Systemic or neurological disease
  • Peripheral vascular disease or endothelial dysfunction
  • Conditions associated with endothelial dysfunction, including uncontrolled hypertension, cardiovascular disease, systemic inflammation, obesity, diabetes, or atherosclerosis
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, 3500, Turkey (Türkiye)

Location

Related Publications (2)

  • Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.

    PMID: 10846023BACKGROUND
  • Kohia M, Brackle J, Byrd K, Jennings A, Murray W, Wilfong E. Effectiveness of physical therapy treatments on lateral epicondylitis. J Sport Rehabil. 2008 May;17(2):119-36. doi: 10.1123/jsr.17.2.119.

    PMID: 18515912BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Blood Flow Restriction TherapyOrthotic Devices

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Research Assisstant

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 4, 2026

Study Start

November 15, 2021

Primary Completion

October 15, 2024

Study Completion

December 20, 2024

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the institutional review board approval limitations.

Locations