Comparison of the Effects of Extracorporeal Shock Wave Therapy and Exercise on Pain, Flexibility, and Balance in Individuals With Hamstring Tightness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
This randomized controlled trial aims to compare the short- and long-term effects of extracorporeal shock wave therapy (ESWT) and exercise therapy on pain, flexibility, and balance in individuals with low back pain associated with hamstring tightness. Thirty participants will be randomized into two groups (ESWT or exercise) and receive interventions twice weekly for four weeks. Outcomes include pain (a (VAS), flexibility (Popliteal Angle and Fingertip-to-Floor tests), and balance (Y-Balance Test), assessed at baseline, post-intervention, and at a four-week follow-up.
详细描述
This study evaluates the efficacy of ESWT versus exercise therapy in managing low back pain due to hamstring tightness. Participants with diagnosed hamstring tightness and low back pain will be randomly assigned to receive either ESWT or an exercise program, each administered twice weekly for four weeks. The ESWT group will receive standardized shock wave therapy targeting the hamstring muscles and related structures, alongside core exercises. The exercise group will perform a structured program including hamstring stretching and lumbar stabilization exercises, also with core exercises. Assessments will occur at baseline, immediately post-intervention, and four weeks post-treatment. Pain will be measured using the Visual Analog Scale (VAS), flexibility via Popliteal Angle (PA) and Fingertip-to-Floor (FTF) tests, and balance using the Y-Balance Test (YBT). Data will be analyzed using Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), 26.0, with a significance level of p<0.05. The study hypothesizes that ESWT may provide faster pain relief and balance improvements, while exercise may offer more sustained flexibility gains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study employs single blinding, where outcomes assessors are masked to participants' group assignments. Thirty participants are randomized into two groups (extracorporeal shock wave therapy or exercise therapy), with interventions administered by unblinded study personnel. To minimize bias, assessors measuring outcomes, including pain intensity (Visual Analog Scale), hamstring flexibility (Popliteal Angle and Fingertip-to-Floor tests), and dynamic balance (Y-Balance Test), are unaware of the intervention each participant receives. Participants and intervention providers are not blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diagnosed with low back pain due to hamstring tightness.
- •Aged 18-65 years.
- •Male or female.
- •Medically cleared for ESWT or exercise therapy.
- •Experienced low back pain in the past 6 months without serious spinal pathology (e.g., herniated disc, fracture).
排除标准
- •• Other musculoskeletal conditions causing low back pain (e.g., disc herniation, spinal stenosis).
- •Outside the specified age range.
- •Serious health conditions that may affect study outcomes.
- •Pregnant or breastfeeding women.
- •Surgical intervention in the back or hamstring region within the past 6 months.
研究组 & 干预措施
ESWT Group
Participants in this group will receive ESWT two times per week for 4 weeks. The treatment will target hamstring muscles and related structures using a standardized ESWT protocol (fixed frequency, intensity, and session duration). In addition to ESWT, participants will perform core strengthening exercises during each session.
干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)
Exercise Group
Participants in this group will perform a structured exercise program three times per week for 4 weeks. Each session will last 30-45 minutes and will include hamstring stretching, lumbar stabilization, and core strengthening exercises.
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Pain Intensity
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
Hamstring Flexibility (Popliteal Angle)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured using the Popliteal Angle Test with a goniometer in degrees to assess hamstring muscle flexibility.
Hamstring Flexibility (Fingertip-to-Floor Distance)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured in centimeters as the vertical distance between the fingertip and the floor during a forward bend with knees extended.
Dynamic Balance (Y-Balance Test)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured in centimeters using the Y-Balance Test in anterior, posteromedial, and posterolateral directions.
Pain Intensity
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.
Hamstring Flexibility (Popliteal Angle)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured using the Popliteal Angle Test with a goniometer in degrees to assess hamstring muscle flexibility.
Hamstring Flexibility (Fingertip-to-Floor Distance)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured in centimeters as the vertical distance between the fingertip and the floor during a forward bend with knees extended.
Dynamic Balance (Y-Balance Test)
时间窗: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)
Measured in centimeters using the Y-Balance Test in anterior, posteromedial, and posterolateral directions.
次要结局
未报告次要终点
研究者
Mitra Valaei Bakhshayesh
Principal Investigator,MSc Student in Physiotherapy and Rehabilitation
Bahçeşehir University