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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-08-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Low Back Pain Hamstring Tightness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Exercise Program

Intervention Type 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.

Interventions

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Extracorporeal Shock Wave Therapy (ESWT)

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.

Intervention Type DEVICE

Exercise 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No