Comparison of the Effects of Extracorporeal Shock Wave Therapy and Exercise on Pain, Flexibility, and Balance in Individuals With Hamstring Tightness
Phase: NA
Conditions: Low Back Pain, Hamstring Tightness
Sponsor: Bahçeşehir University

Official Title:
Comparison of the Effects of Extracorporeal Shockwave Therapy and Stretching
Exercises on Pain, Flexibility, and Balance in Individuals with Low Back Pain Due to
Hamstring Tightness
NCT Number:
Pending
Date of Document:
November 2024
Protocol ID: BAH-YLTez25
Principal Investigator: Mitra Valaei Bakhshayesh, MSc
Affiliation: Bahçesehir University

1 Study Identification
Unique Protocol ID: BAH-YLTez25
Brief Title: Comparison of ESWT and Exercise for Low Back Pain Due to Hamstring
Tightness
Oﬃcial Title: Comparison of the Eﬀects of Extracorporeal Shock Wave Therapy (ESWT)
and Exercise on Pain, Flexibility, and Balance in Individuals with Low Back Pain Asso-
ciated with Hamstring Tightness
Secondary IDs: None
2 Study Status
Record Verification Date: November 2024
Overall Status: Active, not recruiting
Study Start Date: January 10, 2025
Primary Completion Date: May 20, 2025
Study Completion Date: August 20, 2025 (Anticipated)
3 Sponsor/Collaborators
Sponsor: None
Responsible Party: Principal Investigator
Investigator: Mitra Valaei Bakhshayesh, MSc, Physiotherapy and Rehabilitation, Bahçe-
sehir University
Collaborators:
• Prof. Dr. Hasankerem Alptekin, Istanbul Bahçesehir University
• Assoc. Prof. Dr. Tugba Sahbaz, Istanbul Beykent Hospital
4 Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
U.S. FDA IND/IDE: No
Human Subjects Review:

• Board Status: Approved
• Approval Number: 61351342/020-631
• Board Name: Uskudar University Ethical Committee
• Board Aﬃliation: Bahçesehir University
• Contact:
– Phone: +902164002222
1– Email: bilgi@uskudar.edu.tr
– Address: Altunizade Mh. Universite sokagi No: 14, PK: 34662 Uskudar,
Istanbul, Turkey
5 Study Description
5.1 Brief Summary
This randomized controlled trial aims to compare the short- and long-term eﬀects of ex-
tracorporeal 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 inter-
ventions twice weekly for four weeks. Outcomes include pain (Visual Analog Scale, 
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.
5.2 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 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.
6 Conditions
• Low Back Pain
• Hamstring Tightness
Keywords: Low back pain, Hamstring tightness, Flexibility, Balance, Exercise, Shock
wave therapy, Extracorporeal Shock Wave Therapy (ESWT)
7 Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable (Non-drug intervention)
2Intervention Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 participants
8 Arms and Interventions
8.1 Arms
1. ESWT Group (n = 15):
• Receives extracorporeal shock wave therapy (ESWT) 2 times per week for 4
weeks, targeting hamstring muscles and related structures, plus core exercises.
• Standardized ESWT protocol for frequency, intensity, and session duration.
2. Exercise Group (n = 15):
• Receives a structured exercise program 3 times per week for 3 weeks, including
hamstring stretching, lumbar stabilization, and core exercises.
• Each session lasts 30-45 minutes.

8.2 Interventions
• Device: Extracorporeal Shock Wave Therapy (ESWT): Non-invasive ther-
apy delivering high-energy shock waves to stimulate healing in musculoskeletal tis-
sues.
• Behavioral: Exercise Program: Structured exercises focusing on hamstring
flexibility and lumbar stabilization, supplemented with core exercises.
9 Outcome Measures
9.1 Primary Outcome Measures
1. Pain Intensity
• Time Frame: Pre-treatment (Baseline), Post-treatment (Week 4), Follow-up
(Week 8)
• Measured using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates
no pain and 10 indicates the worst possible pain.
2. Hamstring Flexibility
• Time Frame: Pre-treatment (Baseline), Post-treatment (Week 4), Follow-up
(Week 8)
3• Assessed using the Popliteal Angle (PA) test (degrees) and the Fingertip-to-
Floor (FTF) test (cm).
3. Dynamic Balance
• Time Frame: Pre-treatment (Baseline), Post-treatment (Week 4), Follow-up
(Week 8)
• Measured using the Y-Balance Test (YBT) in the anterior, posteromedial, and
posterolateral directions (cm).
9.2 Secondary Outcome Measures
1. Patient Satisfaction
• Time Frame: Post-treatment (Week 4)
• Assessed via a questionnaire with response options: Very Satisfied, Satisfied,
Not Satisfied.
2. Functional Improvement
• Time Frame: Post-treatment (Week 4), Follow-up (Week 8)

• Evaluated based on participants’ subjective reports regarding pain, mobility,
and balance (Improved, Same, Worsened).
10 Eligibility Criteria
Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts 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).
4• 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.
11 Contacts and Locations
11.1 Contacts
• Primary Contact: Mitra Valaei Bakhshayesh, MSc
– Phone: +90 541862 1639
– Email: mitravalaei2965@gmail.com
• Secondary Contact: Hasankerem Alptekin, Prof. Dr.
– Phone: +90 5062392426
– Email: hasankerem.alptekin@bau.edu.tr
11.2 Locations

• Bahçesehir University, Physiotherapy and Rehabilitation, Istanbul, Turkey, 34353
– Status: Not yet recruiting
– Contact: Mitra Valaei Bakhshayesh (details above)
12 Results
Results Submission: Not applicable (study not yet finished).
Results Point of Contact: Mitra Valaei Bakhshayesh, MSc
Phone: +90 541862 1639
Email: mitravalaei2965@gmail.com
5Study Protocol with Statistical Analysis Plan
STATISTICAL ANALYSIS PLAN (SAP)
Title: Comparison of the Effects of Extracorporeal Shock Wave Therapy and Stretching 
Exercises on Pain,
Flexibility, and Balance in Individuals with Low Back Pain Due to Hamstring Tightness
Principal Investigator: Mitra Valaei Bakhshayesh, MSc in Physiotherapy and 
Rehabilitation
Institution: Bahcesehir University, Istanbul, Turkey
Date: July 2025
1. Objectives of Statistical Analysis
This SAP outlines the statistical methodology for evaluating the effects of ESWT and 
stretching exercises on
pain, hamstring flexibility, and dynamic balance in adults with low back pain due to 
hamstring tightness.
2. Outcome Variables
Primary Outcomes:
- Pain intensity measured by Visual Analog Scale (VAS)
- Hamstring flexibility assessed using Popliteal Angle (PA) and Fingertip-to-Floor (FTF) 
tests
- Dynamic balance assessed using the Y-Balance Test (YBT)
Secondary Outcomes:
- Patient satisfaction

- Subjective functional improvement
3. Study Design Overview
This is a two-arm parallel randomized controlled trial with repeated measures at baseline,
week 4, and week
8. Participants (n = 30) are randomly allocated into two equal groups.
Page 1Study Protocol with Statistical Analysis Plan
4. Sample Size Determination
Sample size (n = 30) was determined via a priori power analysis using G*Power 
software. Effect size: f =
0.336, = 0.05, power = 0.95, 3 measurement points.
5. Statistical Methods
- Descriptive statistics (mean SD) will summarize all outcomes.
- Normality will be assessed via the Shapiro-Wilk test.
- Between-group differences: Independent samples t-test for normally distributed data; 
Mann-Whitney U test
for non-normal distributions.
- Within-group changes over time: Repeated Measures ANOVA; if assumptions violated,
the Friedman test
will be used.
- Interaction effects (Group Time) will be analyzed using Mixed ANOVA.
- Post-hoc pairwise comparisons will be corrected with Bonferroni adjustment.
- Categorical data (e.g., satisfaction levels) will be analyzed using chi-square tests or 
Fishers exact test.
6. Handling of Missing Data
Missing data will be managed using the Last Observation Carried Forward (LOCF) 
method. Sensitivity
analyses will be conducted if >10% data are missing.
7. Statistical Software
All analyses will be conducted using IBM SPSS Statistics version 26.0 (Armonk, NY, 
USA).
8. Significance Level

Statistical significance will be set at p < 0.05 for all analyses.
Page 2Study Protocol with Statistical Analysis Plan
9. Ethical Considerations
This analysis plan is part of an ethically approved protocol (Approval No: 61351342/020-
631).
10. Amendments
Any deviations from this plan will be documented and justified in the final report.
Page 3Study Protocol with Statistical Analysis Plan
STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN (SAP)
Title: Comparison of the Effects of Extracorporeal Shock Wave Therapy and Stretching 
Exercises on Pain,
Flexibility, and Balance in Individuals with Low Back Pain Due to Hamstring Tightness
Principal Investigator: Mitra Valaei Bakhshayesh, MSc in Physiotherapy and 
Rehabilitation
Institution: Bahcesehir University, Istanbul, Turkey
Date: July 2025
Protocol ID: BAH-YLTez25
1. Background and Rationale
Low back pain (LBP) is a global health concern, with hamstring tightness identified as a 
contributing
biomechanical factor. ESWT and stretching exercises are common non-invasive 
treatments, yet their
comparative efficacy in managing LBP associated with hamstring tightness is unclear. 
This study aims to
address that gap.
2. Study Objectives
To compare the short- and long-term effects of ESWT and stretching exercises on pain 
intensity, hamstring
flexibility, and dynamic balance.
3. Study Design
- Randomized controlled trial (parallel-arm)

- 30 participants, randomly assigned (15 per group)
- Three assessment time points: baseline, post-treatment (week 4), follow-up (week 8)
4. Participants
Page 1Study Protocol with Statistical Analysis Plan
Inclusion Criteria:
- Aged 1865 years
- LBP with clinically confirmed hamstring tightness
- VAS 4, PA < 120, FTF > 10 cm
Exclusion Criteria:
- Spinal surgery, systemic disease, pregnancy, neurological or inflammatory conditions, 
ESWT
contraindications
5. Interventions
Group 1: ESWT (2x/week for 4 weeks, 2000 pulses/session, 3.0 bar, 0.5 Hz) + core 
exercises
Group 2: Supervised static stretching protocol (3x/week for 3 weeks) + home program 
during follow-up
6. Outcome Measures
- Pain: VAS (cm, 010)
- Flexibility: Popliteal Angle (degrees), Fingertip-to-Floor (cm)
- Balance: Y-Balance Test (normalized % reach and composite score)
7. Assessment Schedule
All measures taken at Baseline, Week 4, and Week 8.
8. Statistical Analysis Plan (SAP)
- SPSS v26.0 used for all analysis
- Normality: Shapiro-Wilk
- Between-groups: Independent t-test / Mann-Whitney U test
- Within-groups: Repeated Measures ANOVA / Friedman test
Page 2Study Protocol with Statistical Analysis Plan
- Post-hoc: Bonferroni correction
- Significance: p < 0.05

- Handling missing data: LOCF (Last Observation Carried Forward)
9. Ethical Considerations
Approved by Uskudar University Ethics Committee (No: 61351342/020-631). All 
participants provided
informed consent.
10. Facilities and Oversight
Study conducted at Bahcesehir University, Istanbul. PI: Mitra Valaei Bakhshayesh. 
Oversight provided by
institutional supervisors and ethics committee.
Page 3INFORMED CONSENT FORM
STUDY TITLE:
Comparison of the Effects of Extracorporeal Shock Wave Therapy (ESWT) and Exercise 
on
Pain and Balance in Individuals with Low Back Pain Due to Hamstring Tightness
Dear Participant,
You are invited to participate in a clinical research study. Participation is entirely 
voluntary.
Before deciding, it is important that you understand the purpose of the study, how your 
data will
be used, what the study involves, and any potential risks or benefits.
Please take your time to read the following information carefully. If you agree to 
participate,
please sign the consent section at the end of this form. You may withdraw from the study 
at any
time without any negative consequences. No payment or material contribution will be 
requested
from you.
PURPOSE OF THE STUDY:
This study aims to compare the effects of extracorporeal shock wave therapy (ESWT) 
and

exercise therapy on pain and balance in individuals with low back pain caused by 
hamstring
tightness. The goal is to determine the most effective approach for managing this 
condition.
METHODS AND PROCEDURES:
Participants will be randomly assigned into one of two groups:
 ESWT Group: Participants will receive ESWT once or twice per week for 4 weeks, 
along
with core stabilization exercises. Exercise Group: Participants will follow a stretching 
and lumbar stabilization program,
performed 1–2 times per week for 3 weeks, with core exercises included.
ASSESSMENT SCHEDULE:
All participants will be evaluated at the following times:
 Before treatment (Baseline)
 After 4 weeks of treatment
 At 8 weeks (1-month follow-up)
MEASUREMENTS:
 Pain: Visual Analog Scale (VAS, 0–10 scale)
 Flexibility: Popliteal Angle Test and Fingertip-to-Floor Test
 Balance: Y-Balance Test
RISKS AND DISCOMFORTS:
Participants may experience mild pain, muscle soreness, or fatigue during or after 
treatment. All
procedures will be conducted under professional supervision.
BENEFITS:
Participants may experience:
 Reduced pain
 Improved flexibility and balance
The study may also contribute to scientific knowledge and benefit future 
patients.CONFIDENTIALITY:

All personal data will be kept strictly confidential and used only for scientific purposes. 
You will
not be identified in any reports or publications.
VOLUNTARY PARTICIPATION:
Your participation is voluntary. You may withdraw at any point without providing a 
reason and
without affecting your rights or access to services.
CONTACT INFORMATION:
Principal Investigator: Mitra Valaei Bakhshayesh
Phone: +90 541 862 1639
Email: mitravalaei2965@gmail.com
CONSENT STATEMENT:
I have read and understood the above information. I had the opportunity to ask questions 
and all
of them have been answered. I voluntarily agree to participate in this study.
Participant Name: ___________________________________
Signature: __________________________________________
Date: _______________
Investigator Name: ___________________________________
Signature: __________________________________________
Date: _______________