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Trial record 23 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03326544
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

Knee osteoarthritis, as a progressive disease is one of the most common causes of pain, motor disorder and disability in the elderly. By increasing age, the cartilage is eroded and endures degenerative changes due to physiological and biomechanical changes as well as metabolic effects and trauma . Non-surgical interventions for pain control of knee osteoarthritis include weight loss, exercise, changes in daily activities, physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics .However ,the intra-articular injection is recently recommended by many studies such as corticosteroids, hyaluronic acid, Growth hormone, dextrose ,and platelet rich plasma.

Intra-articular injection of platelets are activated and undergo degranulation, releasing a range of growth factors, including transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor, vascular endothelial growth factors, epidermal growth factors and basic fibroblast growth factor 2. These growth factors are thought to activate a variety of signaling pathways, which promote healing of bone and soft tissue.Also,some minimally invasive therapeutic options have been effective in pain relieve in KA, such as ultrasound-guided saphenous nerve block .


Condition or disease Intervention/treatment Phase
Chronic Knee Joint Osteoarthritis Other: Saphenous nerve block group Other: Platelet rich plasma group Not Applicable

Detailed Description:
The aim of this study is to compare the efficacy of ultrasound guided saphenous nerve block versus platelet rich plasma injection in the management of chronic pain in patients with knee OA. This study will be conducted to evaluate which modality is more effective.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Ultra-sound Guided Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Joint Osteoarthritis
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Saphenous nerve block group
Patients will receive ultrasound-guided intervention treatment with a sub-sartorial approach for a saphenous nerve block with 8 mL of bupivacaine 0.5% plus dexamethasone 4 mg
Other: Saphenous nerve block group
Patients will receive ultrasound-guided intervention treatment with a sub-sartorial approach for a saphenous nerve block with 8 mL of bupivacaine 0.5% plus dexamethasone 4 mg

Experimental: Platelet rich plasma group
Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma
Other: Platelet rich plasma group
Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma




Primary Outcome Measures :
  1. Pain scores [ Time Frame: For 6 months after intervention ]
    The severity of pain will be assessed using a visual analog scale (VAS)


Secondary Outcome Measures :
  1. Quality of life (QOL) [ Time Frame: For 6 months after intervention ]
    is evaluated using the Western Ontario and MC Master universities (WOMAC) index of osteoarthritis



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are not competent to understand the study protocol
  • Radiographic evidence of OA of knee of 2nd degree.
  • Chronic pain for at least 6 months prior to study entry (day 0).
  • Pain relief not achieved with conservative therapies during the last 6 months

Exclusion Criteria:

  • Patient refusal.
  • Bleeding disorders.
  • Coagulation disorders.
  • Local skin infection
  • Current other problem in the affected extremity .
  • Psychiatric disorders affecting co-operation of the patient .
  • Previous chronic opioid use.
  • Intra articular knee injection within previous three months.
  • History of traumatic arthropathy.
  • History of neuropathic arthropathy.
  • Allergy or hypersensitivity to any of the study medication.
  • Any condition that could interfere with the interpretation of the outcome assessments.
  • Pregnancy
  • Lactating women.
  • low back pain due to central cause.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326544


Locations
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Egypt
Mansoura University Hospitals
Mansourah, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03326544     History of Changes
Other Study ID Numbers: MS/17.07.80
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases