- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07627581
Foam Roller Versus Self-Performed Neurodynamic Sliding in People With Hamstring Tightness and Low Back Pain History
Effects of Self-Myofascial Release With Foam Roller Versus Self-Performed Neurodynamic Sliding on Hamstring Flexibility in People With Hamstring Tightness and a History of Low Back Pain: A Randomized Pilot Clinical Trial
This randomized crossover pilot clinical trial evaluated the effects of two self-administered physiotherapy techniques in people with hamstring tightness and a history of non-specific low back pain.
Participants were randomly assigned to one of two treatment sequences. One sequence performed self-myofascial release using a foam roller first, followed by a one-month washout period, and then performed a self-administered neurodynamic sliding technique. The other sequence performed the neurodynamic sliding technique first, followed by a one-month washout period, and then performed the foam roller intervention.
The main objective of the study was to compare the effects of both interventions on hamstring flexibility. Secondary outcomes included active knee extension range of motion, dynamic balance, pressure pain threshold, hamstring and gluteus maximus strength, and low back pain intensity.
Přehled studie
Postavení
Podmínky
Detailní popis
Low back pain is a common musculoskeletal condition, and hamstring tightness has been proposed as a potential contributing factor due to its influence on pelvic and lumbar biomechanics. Different physiotherapy interventions may be used to improve hamstring flexibility, including self-myofascial release with a foam roller and neurodynamic sliding techniques.
This study was designed as a randomized, crossover, pilot clinical trial with two active interventions. Participants were people with hamstring tightness and a history of recurrent or chronic non-specific low back pain. Eligible participants were randomly assigned to one of two intervention sequences.
In one sequence, participants first performed self-myofascial release using a foam roller on the hamstring muscles. After a one-month washout period, they then performed the self-administered neurodynamic sliding technique. In the other sequence, participants first performed the self-administered neurodynamic sliding technique. After a one-month washout period, they then performed the self-myofascial release intervention using a foam roller.
The foam roller intervention consisted of bilateral self-myofascial release of the hamstring muscles for 2 minutes per leg over three consecutive days. The neurodynamic sliding intervention consisted of a seated self-administered neurodynamic sliding technique over three consecutive days, with 3 sets of 20 repetitions and 20 seconds of rest between sets.
Assessments were performed before and after each intervention period. The primary outcome was hamstring flexibility measured using the Straight Leg Raising test. Secondary outcomes included hamstring flexibility measured using the Active Knee Extension test, dynamic balance assessed with the Y-Balance Test, pressure pain threshold over myofascial trigger points, isometric strength of the hamstrings and gluteus maximus, and low back pain intensity measured with the Numeric Pain Rating Scale.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sara Perpiña Martinez, PT, PhD
- Telefonní číslo: 1032 (+34) 910053661
- E-mail: sperpinama@upsa.es
Studijní místa
-
-
Madrid
-
Madrid, Madrid, Španělsko, 28015
- Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
-
Kontakt:
- Sara Perpiña Martinez, PT, PhD
- Telefonní číslo: 1032 (+34) 910053661
- E-mail: sperpinama@upsa.es
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Men and women aged 16 years or older.
- History of non-specific low back pain during the previous three months and/or recurrent or chronic non-specific low back pain.
- Limited hamstring flexibility, defined as hamstring tightness with 75 degrees or less of hip flexion with knee extension during the Straight Leg Raise test.
- No previous surgery involving the spine or lower limb.
- No hamstring stretching exercises performed in the weeks prior to participation.
- Ability and willingness to provide informed consent.
- Availability to perform both self-administered physiotherapy techniques according to the study protocol.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- History of hamstring muscle or tendon injury during the previous year.
- Lumbar or lower-limb neurological deficits.
- Lower-limb length discrepancy.
- Specific spinal pathology, including tumor, infection, fracture, or inflammatory disease.
- History of lumbar disc herniation.
- History of whiplash injury.
- Any contraindication to physical exercise.
- Menstrual pain at the time of assessment or intervention.
- Scheduled surgery during the intervention or follow-up period.
- History of cardiac disease.
- Incomplete or incorrectly completed questionnaires or missing assessment data.
- Refusal to complete part or all of the study intervention.
- Development of a low back pain episode during the study intervention.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Foam Roller First, Then Neurodynamic Sliding
Participants assigned to this sequence will first perform self-myofascial release using a foam roller on the hamstring muscles.
After a one-month washout period, they will perform the self-administered neurodynamic sliding technique.
|
Participants will perform bilateral self-myofascial release of the hamstring muscles using a foam roller.
The technique will be performed for 2 minutes per leg over three consecutive days.
Participants will perform a seated self-administered neurodynamic sliding technique over three consecutive days.
The intervention will consist of 3 sets of 20 repetitions, with 20 seconds of rest between sets.
|
|
Experimentální: Neurodynamic Sliding First, Then Foam Roller
Participants assigned to this sequence will first perform the self-administered neurodynamic sliding technique.
After a one-month washout period, they will perform self-myofascial release using a foam roller on the hamstring muscles.
|
Participants will perform bilateral self-myofascial release of the hamstring muscles using a foam roller.
The technique will be performed for 2 minutes per leg over three consecutive days.
Participants will perform a seated self-administered neurodynamic sliding technique over three consecutive days.
The intervention will consist of 3 sets of 20 repetitions, with 20 seconds of rest between sets.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hamstring Flexibility Measured With the Straight Leg Raise Test
Časové okno: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Hamstring flexibility will be assessed using the Straight Leg Raise test.
The test will be performed with the participant in the supine position, and hip flexion range of motion will be measured in degrees using a goniometer.
Higher values indicate greater hamstring flexibility.
|
Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hamstring Flexibility Measured With the Active Knee Extension Test
Časové okno: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Hamstring flexibility will be assessed using the Active Knee Extension test.
The knee extension angle will be measured in degrees using a goniometer, with the hip positioned at 90 degrees of flexion.
|
Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
|
Change in Dynamic Balance Measured With the Y-Balance Test
Časové okno: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Dynamic balance will be assessed using the Y-Balance Test.
Reach distances in the anterior, posteromedial, and posterolateral directions will be recorded in centimeters and normalized to lower limb length.
|
Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
|
Change in Pressure Pain Threshold
Časové okno: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Isometric strength of the hamstring muscles and gluteus maximus will be assessed using a handheld dynamometer.
Values will be recorded in Newtons, with higher values indicating greater muscle strength.
|
Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
|
Change in Low Back Pain Intensity
Časové okno: Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Low back pain intensity will be assessed using the Numeric Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Baseline of each intervention period, 24 hours after completing each intervention, and 7 days after each intervention
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Sara Perpiña Martínez, PT, PhD, Pontifical University of Salamanca
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UPSA_HAM_LBP
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Bolesti v kříži
-
Oslo University HospitalThe Research Council of NorwayNeznámýChronický nespecifický Low Back PianNorsko
-
Guven Health GroupDokončenoBederní disk Herniace | Bolesti zad, mechanické | Low Back Strain | Onemocnění bederní ploténkyKrocan
-
Bozok UniversityDokončeno
-
Health Services Academy, Islamabad, PakistanNeznámýmHealth | Readmise | Teach-Back komunikacePákistán
-
Otsuka Pharmaceutical Co., Ltd.DokončenoHyper-low-density Lipoprotein (LDL) CholesterolémieJaponsko
-
China Medical University HospitalDokončenoBolesti zad | Bolesti v kříži | Bolesti zad, mechanické | Bolesti dolní části zad, opakující se | Bolest dolní části zad, posturální | Low Back Strain | Ústřel | Lumbago S ischias | Lumbago S Ischias, Nespecifikovaná StranaTchaj-wan
-
Otsuka Pharmaceutical Co., Ltd.DokončenoHyper-low-density Lipoprotein (LDL) CholesterolémieJaponsko
-
Liu JiuhongDokončenoRebound Pain | Lipozomální bupivakainČína
-
Rush University Medical CenterDokončenoVzdělávání pacientů | Teach-Back komunikace | Po návštěvě pokynů | Pochopení pacientaSpojené státy
-
Medical College of WisconsinChildren's WisconsinAktivní, ne náborSimulace fyzické nemoci | Komplikace tracheostomie | Teach-Back komunikaceSpojené státy