- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07917611
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Effect of Retro Walking on Isokinetic Peak Torque of Lower Limb Muscles in Patients With Sacroiliac Joint Dysfunction
The goal of this clinical trial is to investigate the effect of adding retro-walking (RW) to core stabilization exercises (CSE) on isokinetic peak torque of lower limb muscles, pain severity, and disability level in patients with sacroiliac joint dysfunction(SIJD).The main questions it aims to answer are:
Will there be any effect for the combined application of RW training and CSE on isokinetic peak torques of, hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD? Will there be any difference between the combined application of RW training and CSE and the solo application of CSE on isokinetic peak torques hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
One of the most overlooked sources of low back pain (LBP) is the sacroiliac joint dysfunction (SIJD). The reported prevalence of chronic mechanical LBP originating from the sacroiliac joint (SIJ) ranges from 15% to 30% with females being affected more than males. SIJ is the largest axial joint in the body that connects the spine to the pelvis and thus transfers load from the lumbar spine to lower extremities and vice versa. During weight bearing activities, the ankle, knee and hip act as a linked system minimizing the transmission of force to the pelvis and spine.
Some studies investigated electromyographic activity of gluteus maximus, gluteus medius and other lumbo-pelvic muscles in patients with SIJD. They found reduced activity of these muscles and delayed onset of activation in SIJD compared with the controls. Also, recent studies found there was a relation between pelvic, and lower limb injuries and SIJD.
Treatment of SIJ pain is variable, and there are no guidelines or an appropriate management plan for this dysfunction. Core Stabilization Exercises (CSE) are a common form of exercise therapy used to treat LBP and SIJD. Backward walking (BW) or retro-walking (RW) is a recently emerging exercise that helps enhance the balance, muscle strength of the lower limbs and hamstring flexibility. Reviewing the literature revealed that there was no study investigated the effect of BW training on lower limb muscles' strength, pain, and disability in patients with SIJD. Yet, there is a gap in literature regarding the effect of RW training on hip, knee, and ankle muscles' strength in such patients. Furthermore, the effect of adding RW training to CSE on such variables wasn't previously investigated. So, the current study will be conducted to fill this gap, by investigating the effect of adding RW to CSE on isokinetic peak torques of hip extensors and abductors, knee extensors, ankle planter-flexors, pain severity, and disability level in patients with SIJD. Additionally, this study aims to compare the changes in the selected parameters after applying RW in addition to CSE versus applying CSE only in patients with SIJD.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age ranging from 20-40 years.
- pain lasting for more than 3 months
- ≥ 4 in diagnostic scoring system (Kurosawa et al., 2017).
- 3 or more positive provocative test of SIJ tests (distraction test, compression test, sacral trust, thigh trust test, gaenslen test).
- Pain in or around the sacroiliac region with or without leg pain.
Exclusion Criteria:
- Midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficit).
- A history of spinal surgery, infection, tumors fracture of the spine, pelvis or lower extremities.
- Hospitalization for severe trauma or car accident.
- Pregnancy or lactation.
- Any systemic disease such as arthritis, tuberculosis.
- Leg length discrepancy and scoliosis.
- Injection of corticosteroids or anesthetics in the SIJ during the previous month.
- Participating in physical therapy for 3 months prior the study.
- Taking non-steroidal anti-inflammatory drugs during the therapy.
- Participating in any regular exercise.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental group
Patients will perform core stabilization exercises combined with backward walking training. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 40-50 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
|
Actieve vergelijker: Control group
Patients will perform core stabilization exercises only. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 20-30 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Isokinetic peak torque of lower limb muscles
Tijdsspanne: The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
Biodex System 3 Multi-Joint system testing and rehabilitation (Biodex Medical system, Shirley, NY, USA) will be used to measure peak torques of hip extensors and abductors, in addition to knee extensors and ankle planter flexors at an angular velocity of 60°/sec. |
The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
|
Pain intensity
Tijdsspanne: VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
Visual analog scale (VAS) will be used for measuring the pain intensity. |
VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Functional disability
Tijdsspanne: ODI score will be measured at the beginning and after six weeks for the two tested groups
|
Oswestry disability index (ODI) will be used for assessing pain related disability and quality of life |
ODI score will be measured at the beginning and after six weeks for the two tested groups
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- P.T.REC/012/005650
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .