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Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

Primary Purpose

Chronic Knee Joint Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Saphenous nerve block group
Platelet rich plasma group
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Knee Joint Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Saphenous nerve block group

Platelet rich plasma group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life (QOL)
is evaluated using the Western Ontario and MC Master universities (WOMAC) index of osteoarthritis

Full Information

First Posted
October 26, 2017
Last Updated
September 19, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03326544
Brief Title
Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis
Official Title
Ultra-sound Guided Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Joint Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Joint Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saphenous nerve block group
Arm Type
Experimental
Arm Description
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
Arm Title
Platelet rich plasma group
Arm Type
Experimental
Arm Description
Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma
Intervention Type
Other
Intervention Name(s)
Saphenous nerve block group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Platelet rich plasma group
Intervention Description
Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma
Primary Outcome Measure Information:
Title
Pain scores
Description
The severity of pain will be assessed using a visual analog scale (VAS)
Time Frame
For 6 months after intervention
Secondary Outcome Measure Information:
Title
Quality of life (QOL)
Description
is evaluated using the Western Ontario and MC Master universities (WOMAC) index of osteoarthritis
Time Frame
For 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

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