NCT07007455

Brief Summary

Repetitive and aggressive injuries to the elbow joint in sports often cause lateral elbow tendinitis (LET). In many clinical settings, therapists follow conventional methods according to their treatment protocols; however, complete rehabilitation is not always implemented. Without adequate care, elbow tendinitis can lead to chronic and recurring elbow injuries. Although many treatments are available, Blood flow restriction training (BFR) is a valuable option for exercise in cases where high-intensity training is too painful or contraindicated. In musculoskeletal disorders, it has been shown to induce hypoalgesia, and positive effects, such as improved muscle strength, growth, and tendon adaptations, have been demonstrated in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

February 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

December 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

May 28, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Wrist extensor strength traininglateral epicondylitisTennis elbowelbow pain

Outcome Measures

Primary Outcomes (2)

  • pressure pain thresholds (PPTs).

    before and after intervention.

    six weeks

  • pain-free grip strength test

    before and after intervention.

    six weeks

Secondary Outcomes (1)

  • Borg 6-20 scale

    six weeks

Study Arms (2)

Experimental Group: wrist extensor strength training with BFR.

EXPERIMENTAL

Experimental Group: Participants will undergo wrist extensor strength training with blood flow restriction (BFR).

Behavioral: wrist extensor strength training with BFR.

Control Group: Wrist extensor strength training without BFR.

ACTIVE COMPARATOR

Control Group: Participants will undergo the same wrist extensor strength training without blood flow restriction (BFR).

Behavioral: wrist extensor strength training without BFR.

Interventions

Wrist extensor strength training without BFR.

Also known as: Wrist extensor strength training without BFR.
Experimental Group: wrist extensor strength training with BFR.

wrist extensor strength training without BFR.

Control Group: Wrist extensor strength training without BFR.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Male and female, aged between 18 to 45 years old.
  • Subjects with a positive test of lateral epicondylitis, which will be determined based on physical therapy assessment procedures.
  • The presence of tenderness over the lateral epicondyle.positive Cozen's and Mill's tests.
  • Pain on grasping.
  • Pain on passive flexion of the wrist with elbow extension.
  • Pain with resisted wrist extension.
  • Show decreased muscle strength and functional ability.

You may not qualify if:

  • Patients with shoulder tendinopathy, cervical radiculopathy, and rheumatoid arthritis.
  • Presences of sensory and motor impairment of the upper extremities
  • History of cardiovascular disease
  • History of trauma and surgery on the elbow
  • Having a history of malignancy and peripheral vascular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Rehabiltation Center

Al Majma'ah, Al Riyadh, 11952, Saudi Arabia

Location

Majmaah University

Al Majma'ah, Al-Riyadh, Majmaah University, Saudi Arabia

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were randomly assigned to the experimental group (WEST-BFR) and the control group (WEST without BFR).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be a randomized controlled trial aimed at evaluating the effectiveness of wrist extensor strength training with blood flow restriction (BFR) in reducing pain, improving grip strength, and enhancing functional performance in individuals with lateral elbow tendinopathy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

February 15, 2025

Primary Completion

May 15, 2025

Study Completion

May 25, 2025

Last Updated

December 8, 2025

Record last verified: 2025-01

Locations