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

NCT ID: NCT07140796

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2026-01-01

Brief Summary

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.

Detailed 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.

Conditions

Genu Varum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BFR Only

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction Training

Intervention Type: BEHAVIORAL

Participants perform squats with 15% of their body weight under blood flow restriction using a thigh cuff. Hip internal rotation is set at 15 degrees. The training is conducted twice a week for 4 weeks. Cuff pressure is estimated using a predictive formula based on thigh circumference and systolic blood pressure.

Radial Extracorporeal Shockwave Therapy

Intervention Type: DEVICE

Radial extracorporeal shockwave therapy (rESWT) is applied to the gluteus medius region prior to each exercise session. The protocol includes 2000 pulses per session, applied twice per week for 4 weeks, using a radial shockwave device.

BFR + Shockwave

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction Training

Intervention Type: BEHAVIORAL

Participants perform squats with 15% of their body weight under blood flow restriction using a thigh cuff. Hip internal rotation is set at 15 degrees. The training is conducted twice a week for 4 weeks. Cuff pressure is estimated using a predictive formula based on thigh circumference and systolic blood pressure.

Interventions

Blood Flow Restriction Training

Participants perform squats with 15% of their body weight under blood flow restriction using a thigh cuff. Hip internal rotation is set at 15 degrees. The training is conducted twice a week for 4 weeks. Cuff pressure is estimated using a predictive formula based on thigh circumference and systolic blood pressure.

Intervention Type: BEHAVIORAL

Radial Extracorporeal Shockwave Therapy

Radial extracorporeal shockwave therapy (rESWT) is applied to the gluteus medius region prior to each exercise session. The protocol includes 2000 pulses per session, applied twice per week for 4 weeks, using a radial shockwave device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sungjin Park

OTHER

Sponsor Role: lead

Responsible Party

Sungjin Park

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gangnam Su Rehabilitation Medicine Manual & Exercise Therapy Center

Seoul, Seoul, South Korea

Countries

South Korea

Central Contacts

Park sungjin

Role: CONTACT

0803pak@naver.com

82+ 010-4121-4209

Facility Contacts

sungjin Park

Role: primary

0803pak@naver.com

+82-010-4121-4209

Other Identifiers

Sahmyook University

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SYU 2025-06-031-001

Identifier Type: -

Identifier Source: org_study_id