- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07838844
IASTM vs. Static Stretching for Hamstring Tightness: Short- and Long-Term Effects (IASTM-HT)
Comparison of the Short- and Long-Term Effects of Static Stretching and Instrument-Assisted Soft Tissue Mobilization on Flexibility, Performance, and Pressure Pain Threshold in Individuals With Hamstring Tightness: A Randomized Controlled Trial
This study compares two treatments for people with tight hamstring muscles (the muscles at the back of the thigh): instrument-assisted soft tissue mobilization (IASTM) and static stretching. Both are commonly used by physical therapists to improve flexibility, but few studies have looked at their effects beyond a few days after treatment ends.
Forty-six adults with hamstring tightness will be randomly assigned to one of two groups. One group will receive IASTM, and the other will receive static stretching. Both treatments will be given 3 times per week for 4 weeks (12 sessions total).
Researchers will measure flexibility (knee extension range of motion), pressure pain threshold, and physical performance (vertical jump and single-leg hop distance) at three time points: before treatment, 3 days after the last session, and 8 weeks after treatment ends. The goal is to find out which treatment provides better short-term and longer-term benefits.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Hamstring muscle tightness is a common musculoskeletal condition that can limit hip and knee range of motion, reduce athletic and functional performance, and contribute to other conditions such as patellofemoral pain, patellar tendinopathy, and low back pain. Static stretching has long been used to address hamstring tightness, with systematic reviews suggesting that 6-8 weeks of regular stretching can produce lasting flexibility gains. Instrument-assisted soft tissue mobilization (IASTM) has more recently emerged as an alternative technique, with proposed mechanisms including controlled microtrauma that stimulates an inflammatory response and collagen remodeling in soft tissue.
Most existing studies comparing static stretching and IASTM for hamstring tightness have examined only single-session or short-term (immediate post-treatment) effects. Long-term follow-up data (≥8 weeks) are limited, making it difficult to determine whether treatment-related gains in flexibility, pain sensitivity, and functional performance are sustained over time.
This randomized controlled trial will enroll 46 participants with hamstring tightness, defined as hip flexion range of motion <65° on the Straight Leg Raise (SLR) test with no neurological signs. Participants will be randomly allocated (computer-generated randomization) to one of two equal groups (n=23 each):
Group 1 (IASTM): Participants will receive instrument-assisted soft tissue mobilization applied to the hamstring muscle group using a stainless-steel instrument, scanning technique, distal-to-proximal direction, for 5 minutes per session.
Group 2 (Static Stretching): Participants will receive manual static stretching of the hamstring muscle group, performed in 5 repetitions of 30 seconds of stretch followed by 30 seconds of rest (5 minutes total per session).
Both interventions will be delivered 3 times per week for 4 weeks (12 sessions total) by a physical therapist with over 10 years of clinical experience in orthopedic rehabilitation and manual therapy.
Outcome assessments will be performed by a blinded assessor independent of treatment delivery, at three time points: baseline (pre-treatment), short-term (3 days after the final session), and long-term (8 weeks after intervention completion). Outcome measures include:
- Flexibility: knee extension range of motion during 90° hip flexion, measured with a digital inclinometer
- Pressure pain threshold: measured with a digital algometer over the hamstring muscle bellies (biceps femoris, semitendinosus, semimembranosus)
- Functional performance: vertical jump height and single-leg hop distance
Statistical analysis will include two-way repeated-measures ANOVA to assess time and group-by-time interaction effects, with Bonferroni-corrected post hoc comparisons where appropriate.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age 18 years or older
- Hamstring tightness, defined as hip flexion range of motion <65° on the Straight Leg Raise (SLR) test, without neurological signs
- No diagnosed chronic musculoskeletal or systemic disease
- Signed informed consent form
Exclusion Criteria:
- Previous trauma or surgical operation involving the lower extremity
- Neurological symptoms radiating to one or both lower extremities due to hamstring injury, spinal pathology, or sciatic nerve involvement
- Ankle instability
- Pregnancy
- Neurological signs elicited during the Straight Leg Raise (SLR) test
- Hyperalgesia, hematoma, varicose veins, or active skin infection in the lower extremity
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: IASTM
Participants will receive instrument-assisted soft tissue mobilization (IASTM) applied to the hamstring muscle group using a stainless-steel instrument in a scanning technique, distal-to-proximal direction, for 5 minutes per session, 3 times per week for 4 weeks (12 sessions total). |
Participants will receive instrument-assisted soft tissue mobilization (IASTM) applied to the hamstring muscle group using a stainless-steel instrument in a scanning technique, distal-to-proximal direction, for 5 minutes per session, 3 times per week for 4 weeks (12 sessions total). |
|
Aktywny komparator: Static Stretching
Participants will receive manual static stretching of the hamstring muscle group, performed in 5 repetitions of 30 seconds of stretch followed by 30 seconds of rest (5 minutes total per session), 3 times per week for 4 weeks (12 sessions total). |
Participants will receive manual static stretching of the hamstring muscle group, performed in 5 repetitions of 30 seconds of stretch followed by 30 seconds of rest (5 minutes total per session), 3 times per week for 4 weeks (12 sessions total). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Knee Extension Range of Motion (Flexibility)
Ramy czasowe: Baseline, 3 days after final session (short-term), and 8 weeks after intervention completion (long-term)
|
Knee extension range of motion during 90° hip flexion, measured with a digital inclinometer, as an indicator of hamstring flexibility. |
Baseline, 3 days after final session (short-term), and 8 weeks after intervention completion (long-term)
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IASTM-HAM-2026-01
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .