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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03326544
Other study ID # MS/17.07.80
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date September 30, 2018

Study information

Verified date September 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date September 30, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Mansoura University Hospitals Mansourah DK

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scores The severity of pain will be assessed using a visual analog scale (VAS) For 6 months after intervention
Secondary Quality of life (QOL) is evaluated using the Western Ontario and MC Master universities (WOMAC) index of osteoarthritis For 6 months after intervention