- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07710404
Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Osteoarthritis:
Comparative Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Managing Knee Osteoarthritis: A Randomized Clinical Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria
- Patients diagnosed with Grade 2 or Grade 3 Knee Osteoarthritis.
- A Kellgren-Lawrence Grade (KLG) of at least 2.
- Age between 40-60 years.
- Knee pain for at least 6 months.
- A minimum pain score of 3 on the Visual Analogue Scale (VAS).
Exclusion Criteria
- Acute inflammation.
- Total Knee Replacement (TKR) surgery.
- Any lumbar spine disease (disc herniation or lumbar stenosis).
- Intra-articular injection.
- Recent tibia or femur fracture.
- Any systemic inflammatory arthritic condition or neurological condition (e.g., rheumatoid arthritis or stroke).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: GROUP A
The joint distraction is the manual approach in knee osteoarthritis.
This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis.
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The joint distraction is the manual approach in knee osteoarthritis. This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis. A specialized greave would be created to distract the knee joint. Using a platform beneath the lower leg to create counterpressure, the knee would be put in flexion while sustained traction will be performed for 20 minutes while the patient would be in a supine posture. In each session, the traction would be adjusted to the patients' perceived threshold. The least amount of work that caused patients to get distracted would be employed as a diversion |
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Experimentell: GROUP B
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
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The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
Depending on the patient's level of pain and tolerance, an oscillatory accessory approach using Grade III or IV was carried out.
Patients positioned their knees in their true end range while lying supine on the plinth.
The most limited or reproducible knee pain was caused by the accessory approach that was employed.
By moving the therapist's body without making any additional movements, the physical contact accurately replicated the hand position of the mobilization.
For three minutes, Maitland mobilization was carried out twice at a rate of one oscillation every one or two seconds, with a 30-second break in between
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
pain intensity
Tidsram: 4 months
|
Primary Outcome Measure Pain Tool Used: Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) was used to assess the patient's pain level. Participants were asked to rate their pain on a scale from 0 to 10. 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-10 = Severe pain This scale was used to categorize the intensity of pain experienced by patients with knee osteoarthritis. |
4 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life / Broader Function
Tidsram: 4 months
|
Quality of Life / Broader Function Tool Used: KOOS Questionnaire (Knee Injury and Osteoarthritis Outcome Scale. The KOOS questionnaire was used to assess: Pain Symptoms Activities of Daily Living (ADLs) Sport and Recreation Function Knee-related Quality of Life It contains 42 items divided into five sections: Pain = 9 items Symptoms = 7 items Activities of Daily Living = 17 items Sport and Recreation Function = 5 items Quality of Life = 4 items Each item is scored from 0 to 4. Maximum score: 42 items × 4 = 168 Interpretation (Percentage Based): < 40% = Extreme disability 40-59% = Severe problems 60-79% = Moderate problems 80-99% = Mild disability This questionnaire evaluates the overall impact of knee osteoarthritis on function and quality of life.4 months |
4 months
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Disability
Tidsram: 4 months
|
Secondary Outcome Measures 1) Osteoarthritis Symptoms and Functions Tool Used: WOMAC Questionnaire (Western Ontario McMaster Universities Osteoarthritis Index) The WOMAC questionnaire was used to assess: Pain Stiffness Physical function It contains 24 items divided into three sections: Pain = 5 items Stiffness = 2 items Physical Function = 17 items Each question has 5 response options ranging from None to Extreme. Scoring: Each item = 0-4 points Pain section total = 20 Stiffness section total = 8 Physical function section total = 68 Total WOMAC score = 96 Interpretation: 0-30 = Mild 31-60 = Moderate 61-96 = Severe The higher the score, the greater the symptoms and functional limitations. |
4 months
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Passive Range of Motion
Tidsram: 4 months
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Passive Range of Motion Tool Used: Goniometer A goniometer was used to assess joint range of motion. The instrument consists of three parts: Moving Arm - aligned with the body segment that moves. Stationary Arm - aligned with the body segment that remains stationary. Fulcrum - positioned over the joint being assessed. The goniometer was used to measure the knee joint's range of motion before and after treatment. |
4 months
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Samarbetspartners och utredare
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Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TUF/EIRB/143/2025
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