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

NCT07065851 | Active Not Recruiting DMC

• 1 other identifier: Bah-YLTez25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Hamstring Tightness

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  Measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.

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

• Hamstring Flexibility (Popliteal Angle)

  Measured using the Popliteal Angle Test with a goniometer in degrees to assess hamstring muscle flexibility.

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

• Hamstring Flexibility (Fingertip-to-Floor Distance)

  Measured in centimeters as the vertical distance between the fingertip and the floor during a forward bend with knees extended.

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

• Dynamic Balance (Y-Balance Test)

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

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

Study Arms (2)

ESWT Group

EXPERIMENTAL

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.

Device: Extracorporeal Shock Wave Therapy (ESWT)

Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Exercise Program

Interventions

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.

ESWT Group

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Healthy, 34353, Turkey (Türkiye)

Location

Related Publications (3)

• Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The effectiveness of extracorporeal shock wave therapy in lower limb tendinopathy: a systematic review. Am J Sports Med. 2015 Mar;43(3):752-61. doi: 10.1177/0363546514531911. Epub 2014 May 9.

  PMID: 24817008 RESULT

• Schmitz C, Csaszar NB, Rompe JD, Chaves H, Furia JP. Treatment of chronic plantar fasciopathy with extracorporeal shock waves (review). J Orthop Surg Res. 2013 Sep 3;8:31. doi: 10.1186/1749-799X-8-31.

  PMID: 24004715 RESULT

• Rompe JD, Hope C, Kullmer K, Heine J, Burger R. Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. J Bone Joint Surg Br. 1996 Mar;78(2):233-7.

  PMID: 8666632 RESULT

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Extracorporeal Shockwave Therapy; Resistance Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hasankerem Alptekin, Prof.Dr

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,MSc Student in Physiotherapy and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 15, 2025
• Study Start: January 10, 2025
• Primary Completion: May 20, 2025
• Study Completion: August 20, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

TU (1)