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Comparison of Shockwave Therapy and Exercise on Pain, Flexibility, and Balance in Hamstring Tightness

Comparison of the Effects of Extracorporeal Shock Wave Therapy and Exercise on Pain, Flexibility, and Balance in Individuals With Hamstring Tightness

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07065851
Enrollment
30
Registered
2025-07-15
Start date
2025-01-10
Completion date
2025-08-20
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Hamstring Tightness

Keywords

Low back pain, Hamstring tightness, Flexibility, Balance, Exercise, Shock wave therapy, Extracorporeal Shock Wave Therapy (ESWT)

Brief summary

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.

Detailed description

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.

Interventions

Non-invasive therapy delivering high-energy shock waves to stimulate healing in musculoskeletal tissues, targeting the hamstring muscles and related structures, administered 2 times per week for 4 weeks, alongside core exercises.

BEHAVIORALExercise Program

Structured exercises focusing on hamstring flexibility, lumbar stabilization, and core exercises, administered 3 times per week for 3 weeks, with sessions lasting 30-45 minutes.

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

This study employs a parallel assignment model with two intervention arms. Thirty participants with low back pain related to hamstring tightness are randomly assigned to two groups (n=15 each): extracorporeal shock wave therapy (ESWT) or exercise therapy. Interventions are delivered 1-2 times per week for four weeks. The ESWT group receives standardized shock wave therapy targeting the hamstring muscles. The exercise group follows a structured program including hamstring stretching, lumbar stabilization, and core exercises. Participants remain in their assigned groups throughout the study with no crossover. Outcome measures-pain intensity (Visual Analog Scale), hamstring flexibility (Popliteal Angle and Fingertip-to-Floor tests), and dynamic balance (Y-Balance Test)-are assessed at baseline, post-intervention (week 4), and follow-up (week 8). Single blinding is applied for the outcome assessor to minimize bias in measurements.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* • 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).

Exclusion criteria

* • 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityBaseline, 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)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)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)Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)Measured in centimeters using the Y-Balance Test in anterior, posteromedial, and posterolateral directions.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026