- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05031104
Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis
Efficacy of the Articular Application of Low-energy Laser on Knee Joints as an Auxiliary Treatment for Polyarticular Juvenile Idiopathic Arthritis: A Dual-arm Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sixty patients with JIA were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, and the Pediatric Rheumatology Clinic, King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included patients who had a confirmed diagnosis of Polyarticular JIA (according to the criteria set forth by the International League of Associations for Rheumatology), aged 8-16 years, identified being stable cases, and did not participate in a regular exercise program (in the past six months). Patients who had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures were excluded.
Outcome measures
- Pain intensity: measures through the Visual Analogue Scale
- Muscle performance: represented by the peak concentric torque of the right and left quadriceps muscle and measured through an Isokinetic Dynamometer.
- Fatigue perception: tested by the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-MFS)
- Functional status: the functional status was quantified using the cross-cultural validated version of the Childhood Health Assessment Questionnaire (CHAQ).
Patients in the control and LLT group received a 40-minute exercise program, three times a week, for three months in succession. Patients in the LLT group additionally underwent an articular application of LLT on the knee joint, each session before exercises (eight points on each knee, 30 seconds irradiation for each point, with a total irradiation dose of eight minutes per session. The treatment was conducted by two experienced pediatric physical therapists.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Riyadh
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Al Kharj, Riyadh, Saudi Arabien
- Ragab K. Elnaggar
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of JIA
- Polyarticular onset of JIA with bilateral involvement of the knee joint
- Age between 8 and 16 years
- Stable conditions (i.e., receive stable doses of medications in the past three months)
- Not participating in a regular exercise program in the past six months
Exclusion Criteria:
- Fixed deformities
- History of joint surgery
- Ankylosing or fractures
- Bone destruction (erosive changes of the knee joint)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Control group
Patients in this group undergone a standard exercise program.
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The control group received a standard exercise program for 40 minutes, three times a week for three successive months.
The program encompassed aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises.
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Eksperimentel: LLT group
Patients in this group undergone a standard exercise program as the control group in addition to the LLT.
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The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain intensity
Tidsramme: 2 months
|
Pain intensity was measured through the Pain Visual Analogue Scale.
Each child was asked to indicate his/her perceived pain intensity (most commonly) along a horizontal line (0-10 cm), where 0 represents "no pain" and 10 represents "worst pain".
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2 months
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Muscle performance
Tidsramme: 2 months
|
Represented by the peak concentric torque of the quadriceps muscle.
It was measured using an Isokinetic Dynamometer.
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2 months
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Fatigue perception
Tidsramme: 2 months
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The extent of fatigue that patients generally perceive was assessed using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale.
Eighteen items across 3 subscales were rated on a 5-point Likert scale (0 = NEVER a problem and 4 = ALWAYS a problem).
Item scores were linearly transformed on a 0-100 scale.
The total score is calculated as the sum of all item scores divided by the number of rated items.
Lower scores represent higher levels of fatigue perception.
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2 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Functional status
Tidsramme: 2 months
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The patient's ability to perform normal daily activities was assessed through the cross-culture validated version of the Childhood Health Assessment Questionnaire (parents-proxy report)
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2 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ragab K Elnaggar, PhD, Cairo University / Prince Sattam Bin Abdulaziz University
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
- RHPT/0018/027
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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