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NCT Number: NCT07065851

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Low Back Pain Back Pain Behavior Hamstring Tightness Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahcesehir University

Istanbul, Healthy, 34353, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy (ESWT)

Device

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.

Exercise Program

Behavioral

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.

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Hamstring Flexibility (Popliteal Angle)

    Time frame: 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.

  3. Hamstring Flexibility (Fingertip-to-Floor Distance)

    Time frame: 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.

  4. Dynamic Balance (Y-Balance Test)

    Time frame: Baseline, Week 4 (Post-treatment), Week 8 (Follow-up)

    Measured in centimeters using the Y-Balance Test in anterior, posteromedial, and posterolateral directions.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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