- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07826260
Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.
In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.
Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Žiga Kozinc, PhD
- Puhelinnumero: +386 040161503
- Sähköposti: ziga.kozinc@s2p.si
Opiskelupaikat
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-
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Izola, Slovenia, 6310
- Rekrytointi
- University of Primorska, Faculty of Health Sciences, Izola
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Ottaa yhteyttä:
- Žiga Kozinc, PhD
- Puhelinnumero: +386 040161503
- Sähköposti: ziga.kozinc@s2p.si
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Men and women aged 21 to 38 years.
- Resident of the Republic of Slovenia.
- No current low back pain.
- No contraindications to lumbar manual mobilization.
- Ability to assume and maintain the required prone testing position.
- Provision of written informed consent.
Exclusion Criteria:
- Current low back pain.
- Spondylolisthesis.
- Severe osteoporosis.
- Spinal stenosis.
- Lumboischialgia or other significant structural spinal deformity.
- Fibromyalgia.
- Recent spinal surgery or lumbar spinal fixation.
- Cauda equina syndrome.
- Nerve root compression associated with neurological deficits.
- Malignancy.
- Recent relevant trauma.
- Joint instability.
- Active rheumatoid arthritis.
- Acute local or systemic infection.
- Long-term local corticosteroid use.
- Inability to assume or maintain the required testing position.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Mobilization-Sham Sequence
Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
|
|
Active Comparator: Sham-Mobilization Sequence
Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit.
|
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position.
The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham mobilization is applied over the L4 spinous process with the participant in a prone position.
The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets.
The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Erector Spinae Muscle Stiffness
Aikaikkuna: Immediately before and immediately after each intervention session
|
Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
|
Immediately before and immediately after each intervention session
|
|
Change in Multifidus Muscle Stiffness
Aikaikkuna: Immediately before and immediately after each intervention session
|
Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa).
Three measurements are obtained at each time point and averaged.
The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
|
Immediately before and immediately after each intervention session
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Aikaikkuna: Immediately before and immediately after each intervention session
|
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the erector spinae shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
|
Immediately before and immediately after each intervention session
|
|
Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Aikaikkuna: Immediately before and immediately after each intervention session
|
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the multifidus shear wave elastography assessment.
Measurements will be performed immediately before and after each intervention condition.
The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
|
Immediately before and immediately after each intervention session
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- UP-FHS-PA-SWE-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
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