A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnkara Yildirim Beyazıt University

About this trial

Lateral epicondylitis is a chronic degenerative tendinopathy characterized by pain, tenderness, decreased grip strength, and functional limitations, particularly on the outer part of the elbow. While conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and extracorporeal shock wave therapy (ESWT) are used, surgical methods are considered as alternatives in resistant cases. ESWT reduces pain and inflammation by increasing vascularization in the targeted area and supporting tissue regeneration. Blood flow restriction therapy (BFR), on the other hand, promotes muscle hypertrophy and strength gains through low-intensity exercise. The biochemical effects of both methods increase cellular proliferation and protein synthesis through different mechanisms, thereby supporting tissue healing and functional recovery.

However, there are no studies in the literature examining the effects of combining ESWT and BFR in patients with lateral epicondylitis. Therefore, in our study, we aimed to evaluate the effects of the combined application of ESWT and BFR on pain, muscle strength, and functionality in the treatment of lateral epicondylitis.

Patients will be divided into two groups and will undergo treatment for a total of 4 weeks, with one session per week. The study group will receive ESWT treatment in combination with blood flow restriction therapy (BFR). The control group will receive only ESWT. In both groups, the intensity of the ESWT treatment will be increased between sessions based on the patient's pain tolerance. Pain levels, grip strength, wrist isometric muscle strength, and upper extremity functional status will be assessed in patients in both the treatment and control groups before and after treatment. The effectiveness of the methods will be statistically analyzed.

The findings obtained may contribute to the development of an innovative, evidence-based treatment protocol in the field of physical therapy and rehabilitation, thereby filling a gap in the literature aimed at improving pain management and functional recovery in the treatment of lateral epicondylitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having been diagnosed with lateral epicondylitis by a specialist physician

Being between the ages of 18 and 60

Having a body mass index (BMI) between normal weight (18.5-24.9 kg/m²) and overweight (25.0-29.9 kg/m²)

Volunteering to participate in the study

Disqualifiers

Presence of a different elbow pathology

Presence of bilateral lateral epicondylitis

Presence of sensory and motor impairments in the upper extremities

History of surgery in the elbow region

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Flow Restriction Therapy

    Other intervention

    For blood flow restriction therapy, the occlusion pressure will be set at 40%-50% of the arterial occlusion pressure. During the 20-minute blood flow restriction therapy session, upper extremity strengthening, stretching, and stabilization exercises will be performed. The weight used in the strengthening exercises will be selected to be 20%-30% of 1 RM. Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.

  • Extracorporeal Shock Wave Therapy

    Other intervention

    Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Extracorporeal Shock Wave TherapyActive comparator 1 intervention
Group B: Extracorporeal Shock Wave Therapy and Blood Flow Restriction TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity

Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS).

Time frame
Baseline and at the end of 4 weeks
2

Grip Strength

The grip strength will be measured using a Jamar hand dynamometer.

Time frame
Baseline and at the end of 4 weeks
3

Isometric Muscle Strength

Wrist isometric flexion and extension muscle strength will be assessed using the Nicholas MMT Hand-Held dynamometer.

Time frame
Baseline and at the end of 8 weeks.
4

Functional Activity

Functional activity will be assessed using the DASH (Disability of the Arm, Shoulder, and Hand) questionnaire.

Time frame
Baseline and at the end of 4 weeks

Secondary outcomes

Other outcomes

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