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Completed

NCT Number: NCT03326544

Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

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 .

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Key information

Conditions

Chronic Knee Joint Osteoarthritis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saphenous nerve block group

Other

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

Platelet rich plasma group

Other

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

Primary outcomes

  1. Pain scores

    Time frame: For 6 months after intervention

    The severity of pain will be assessed using a visual analog scale (VAS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Ultra-sound Guided Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Joint Osteoarthritis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.