Blood Flow Restriction Training in Tennis Elbow

NCT07710976 | Completed

• 1 other identifier: 2025/5793
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population. Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended. Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise. The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis.

Conditions

Tennis Elbow Syndrome

Keywords

Tennis elbow; grip strength; blood flow restriction training; rehabilitation; ultrasonography; quality of life

Outcome Measures

Primary Outcomes (1)

• Patient-Rated Tennis Elbow Evaluation (PRTEE)

  The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a disease-specific, patient-reported outcome measure designed to assess pain and functional disability associated with lateral epicondylitis (14,15). The questionnaire consists of two domains evaluating pain and functional limitations, with a total score ranging from 0 to 100, where higher scores indicate greater pain and disability. The Turkish version of the PRTEE has demonstrated satisfactory validity and reliability

  Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).

• Pain-free grip strength (PFGS) Assessment

  Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).

• Health-Related Quality of Life

  Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).

• Ultrasonographic Evaluation of the Common Extensor Tendon

  Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).

Study Arms (2)

Blood flow restriction training (BFRT) group

EXPERIMENTAL

The exercise program in this group was performed under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm.

Procedure: Blood Flow Restriction Training

Control group

ACTIVE COMPARATOR

Participants in the control group performed the same exercise protocol without blood flow restriction.

Procedure: Exercise without blood flow restriction

Interventions

Blood Flow Restriction Training PROCEDURE

Both groups participated in a supervised exercise program consisting of 12 sessions over four weeks (three sessions per week), with each session lasting approximately 45 minutes. Each treatment session began with 3-5 minutes of transverse friction massage applied to the painful region, followed by gentle circular soft-tissue mobilization in a proximal-to-distal direction. Resistance exercises were then performed using dumbbells and consisted of concentric and eccentric wrist extension and forearm supination exercises. The order of exercises was standardized for all participants throughout the intervention period. Participants allocated to the BFRT group performed the exercise program under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm. Before the intervention, arterial occlusion pressure (AOP) was individually determined for each participant. The cuff pressure used during training was set at 50% of the individual AOP. Tot

Blood flow restriction training (BFRT) group

Exercise without blood flow restriction PROCEDURE

Participants in the control group performed the identical exercise protocol without blood flow restriction.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years;
• clinical diagnosis of lateral epicondylitis based on medical history and physical examination;
• pain intensity of ≥4 on a 10-cm Visual Analog Scale (VAS) during daily activities;
• provision of written informed consent.

You may not qualify if:

• hypertension, diabetes mellitus, cardiovascular disease, peripheral vascular disease, previous deep vein thrombosis, or lymphedema;
• orthopedic, rheumatologic, or neurological disorders affecting the upper extremity;
• fibromyalgia;
• congenital or acquired elbow deformity;
• previous trauma, fracture, or surgery involving the affected upper extremity;
• cervical radiculopathy or peripheral neuropathy affecting the involved limb;
• receipt of any treatment for lateral epicondylitis within the preceding 3 months;
• skin lesions, infection, or open wounds at the cuff application site;
• bleeding disorders or current anticoagulant therapy;
• pregnancy;
• active malignancy or a history of malignancy;
• cognitive impairment or neurological or psychiatric disorders that could interfere with comprehension of study procedures or completion of outcome assessments.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Blood Flow Restriction Therapy; Exercise

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• SAMİ KÜÇÜKŞEN, Professor

  Necmettin Erbakan University, Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: February 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication- ending 2 years after the publication of results
• Access Criteria: Journal editors or reviewers may request this information from the corresponding author's email address if they deem it necessary.

Locations

TU (1)