Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03326544
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 4.3

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Chronic Knee Joint Osteoarthritis	Other: Saphenous nerve block group; Other: Platelet rich plasma group	N/A

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.

Study Design

• Study Type: Interventional
• Actual 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
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Sep 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain scores [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) [For 6 months after intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals	Mansourah	DK	Egypt	050

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT03326544
• Other Study ID Numbers: MS/17.07.80
• First Posted: Oct 31, 2017
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Sep 22, 2020