Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum (BFR-GVQ)

Sungjin Park

Status: Not yet enrolling

Conditions: Genu Varum

Treatments: Behavioral: Blood Flow Restriction Training; Device: Radial Extracorporeal Shockwave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07140796

SYU 2025-06-031-001

Sahmyook University (Other Grant/Funding Number)

Details and patient eligibility

About

This study aims to investigate the effects of gluteus medius-focused blood flow restriction (BFR) training, with or without the addition of radial shockwave therapy, on lower limb alignment in adults with genu varum. The study uses a crossover design and evaluates changes in Q-angle(Quadriceps-angle) and plantar pressure as primary outcomes. All interventions are non-invasive and supervised, and the goal is to identify effective therapeutic strategies to improve biomechanical alignment in individuals with bowed legs.

Full description

This study investigates the effects of gluteus medius-focused blood flow restriction (BFR) training with or without radial extracorporeal shockwave therapy (rESWT) on lower limb alignment in adults with genu varum. Genu varum, commonly known as bow-leggedness, can lead to altered biomechanical patterns and increased stress on the medial knee joint. Strengthening the hip muscles, particularly the gluteus medius, may contribute to improved alignment and postural stability.

Participants will undergo two different intervention phases in a crossover design. Each phase includes a 4-week intervention period, with a 2-week washout in between. The primary outcome measures are Q-angle (quadriceps angle) and plantar pressure distribution, which will be assessed before and after each intervention phase using validated measurement tools.

This study aims to determine whether BFR training alone or combined with shockwave therapy provides greater improvement in lower limb alignment in individuals with genu varum. All interventions will be supervised, non-invasive, and conducted in a clinical setting under standardized conditions.

Enrollment: 14 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged between 20 and 40 years
• Diagnosed with genu varum (inter-knee distance ≥ 3 cm in standing position)
• No pain or surgery history in lower extremities within the last 6 months
• Able to walk independently without assistance
• Provide written informed consent

Exclusion criteria

• Neurological or musculoskeletal disorders affecting gait or posture
• Current use of medication affecting musculoskeletal or circulatory function
• Previous surgery on the spine, pelvis, or lower limbs
• Contraindications to shockwave therapy or BFR training (e.g., thromboembolic - disorders, deep vein thrombosis, cancer, etc.)
• Participation in other clinical trials within the past month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

BFR Only

Experimental group

Description:

Participants in this group will undergo blood flow restriction (BFR) training alone. BFR training will be performed using a thigh cuff at a pressure estimated based on the participant's thigh circumference and blood pressure. Squats will be performed with 15% of body weight and hip internal rotation at 15 degrees, twice per week for 4 weeks.

Treatment:

Device: Radial Extracorporeal Shockwave Therapy

Behavioral: Blood Flow Restriction Training

BFR + Shockwave

Experimental group

Description:

Participants in this group will receive a combination of blood flow restriction (BFR) training and radial extracorporeal shockwave therapy (rESWT). BFR training will be conducted as in the other arm. Additionally, rESWT will be applied to the gluteus medius region before each exercise session, with 2000 pulses per session, twice per week for 4 weeks.

Treatment:

Behavioral: Blood Flow Restriction Training