- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04918238
Effect of Muscle Energy Techniques on Functional Abilities in Patients With Discogenic Unilateral Sciatica
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Disability and emotional distress among patients with lumbar spondylosis has a negative impact on well-being. Anxiety and depression are common emotional problems among patients with LBP.
The experience of pain interferes with different aspects of the patient's life, negatively affecting their daily activities, physical and mental health, family and social relationships, and their interactions in the workplace.
This problem also affects the health care system and what is known as economic well-being, the strong burden associated with Chronic Pain not only deriving from healthcare costs but also from the loss of productivity and from compensatory payments to patients as a result of the disability that pain produces.
Movement research has vast implications for muscle energy techniques for individuals with chronic low back pain and sciatica, the thoracolumbar normal range of motion plays an essential role in transferring the body weight and performing daily activities. Poor spinal range of motion and tightness of paraspinal muscles have previously been noted in individuals with chronic low back pain and sciatica.
Most of the previous studies focused on dealing with chronic low back pain and sciatica through using different medications and physical therapy modalities for the symptoms such as TENS. Since muscle energy techniques can decrease the tension of the muscles of the lumbar spine and gives a real chance to improve the flexibility of those muscles which might inhibit the severity of sciatica with low costs so it's recommended to study its effect on the functional abilities of the patients so that it can be the main part of physical therapy rehabilitation protocol.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Damietta, Egypten, 34518
- Outpatient clinic - Faculty of Physical Therapy - Horus University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
- Both males and females, aged from 25 to 40 years old.
- Be able to understand and follow the instructions during testing and treatment procedures
Exclusion Criteria:
Fracture of pelvis, spine or lower extremities.
- Hospitalization for severe trauma.
- Peripheral neuropathy of diabetes or any other autoimmune disease.
- Systematic autoimmune disease such as rheumatoid arthritis, systematic lupus
- People with red flags such as cancer or severe osteoporosis.
- Symptoms provoked while doing active hip joint extension and abduction.
- Previous surgery to the lumbar spine, abdomen, pelvis, or hip.
- Any contraindication for exercise therapy (e.g. uncontrolled hypertension, previous myocardial infarction, cardiovascular disease, peripheral vascular disease, respiratory disorders).
- Any pain originated because of SI pathology.
- Menstruation during testing days.
- Individuals incapable of understanding and answering the Questionnaire.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: conventional treatment Arm
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
|
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
|
Eksperimentel: muscle energy technique arm
Group A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program
|
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject.
The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Visual analogue scale (VAS)
Tidsramme: "through study completion, an average of 2 months"
|
Change from baseline Pain and at 2 months
|
"through study completion, an average of 2 months"
|
Oswestry disability index scale
Tidsramme: "through study completion, an average of 2 months"
|
Change from baseline disability and at 2 months
|
"through study completion, an average of 2 months"
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Basem_MSc
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lændesmerter
-
Bozok UniversityAfsluttet
-
Otsuka Pharmaceutical Co., Ltd.Aktiv, ikke rekrutterendeHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan
-
Health Services Academy, Islamabad, PakistanUkendtmHealth | Genoptagelse | Teach-back kommunikationPakistan
-
Rush University Medical CenterAfsluttetPatientuddannelse | Teach-back kommunikation | Efter besøgsinstruktioner | PatientforståelseForenede Stater
-
InQpharm GroupAfsluttetBlodtryk | Low Density Lipoprotein KolesterolniveauTyskland
-
Otsuka Pharmaceutical Co., Ltd.AfsluttetHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinAktiv, ikke rekrutterendeSimulering af fysisk sygdom | Trakeostomi komplikation | Teach-back kommunikationForenede Stater
-
Marmara UniversityAktiv, ikke rekrutterendeTeach-back kommunikationKalkun
-
National Taiwan University HospitalBuddhist Tzu Chi General Hospital; Taipei Medical University Hospital; E-DA... og andre samarbejdspartnereUkendtKoloskopi | Udrensning af tyktarm | Low-Reside diætTaiwan
-
Jordan Collaborating Cardiology GroupThe Cardiovascular Academy Group of the JCS; The Jordan Cardiac Society... og andre samarbejdspartnereAfsluttetAterosklerotisk kardiovaskulær risiko | Low-density-lipoprotein (LDL) kolesterolJordan
Kliniske forsøg med Conventional program
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California...Tilmelding efter invitationStress | Stress, psykologisk | Stress, følelsesmæssig | Stress, Fysiologisk | Stress reaktionForenede Stater
-
University of Maryland, BaltimoreNational Institute of Nursing Research (NINR)AfsluttetOsteoporose | Sundhedsadfærd
-
University of AlcalaRekrutteringLateral epikondylitisSpanien
-
Rush University Medical CenterUniversity of Colorado, Denver; Geisinger Clinic; University of Missouri,... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
University of CagliariSuspenderet
-
Rhode Island HospitalState of Rhode Island Department of Health; Providence Public School District og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... og andre samarbejdspartnereAktiv, ikke rekrutterendeOverernæring | Ernæringsforstyrrelser | Overvægtig | Kropsvægt | Pædiatrisk fedme | Ændringer i kropsvægt | Fedme hos børn | Vægtøgning | Teenagers fedme | Fedme, barndom | Overvægt og fedme | Overvægt eller fedme | Overvægtige ungeForenede Stater
-
University of South CarolinaNational Heart, Lung, and Blood Institute (NHLBI)Afsluttet
-
October 6 UniversityRekruttering
-
GERCOR - Multidisciplinary Oncology Cooperative...Aktiv, ikke rekrutterendeMetastatisk bugspytkirtelkræft | Uoprettelig lokalt avanceret kræftFrankrig