Chronic Knee Joint OsteoarthritisNCT03326544
Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Osteoarthritis
A study testing Saphenous nerve block group and Platelet rich plasma group in people with Chronic Knee Joint Osteoarthritis, run by Mansoura University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Knee Joint Osteoarthritis
- What is being tested?
- Saphenous nerve block group and Platelet rich plasma group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal.
- Bleeding disorders.
- Coagulation disorders.
- Local skin infection
- Current other problem in the affected extremity .
- Psychiatric disorders affecting co-operation of the patient .
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-sound Guided Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Joint 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 .
Read the 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.
- Conditions
- Chronic Knee Joint Osteoarthritis
- Being tested
- Saphenous nerve block group, Platelet rich plasma group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous nerve block groupOther
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 groupOther
Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma
| Study group | Role | What they receive |
|---|---|---|
| Saphenous nerve block group | Experimental | 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 Receives: Other: Saphenous nerve block group |
| Platelet rich plasma group | Experimental | Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma Receives: Other: Platelet rich plasma group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
The severity of pain will be assessed using a visual analog scale (VAS)
Measured: For 6 months after intervention
Secondary outcomes (1)
Quality of life (QOL)
is evaluated using the Western Ontario and MC Master universities (WOMAC) index of osteoarthritis
Measured: For 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee Joint OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326544
- Sponsor's protocol ID
- MS/17.07.80
- Status last verified
- Sep 2020
- First submitted
- 26 Oct 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-sound Guided Saphenous Nerve Block Versus Platelet Rich Plasma for Chronic Knee Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT03326544
- Acronym / sponsor ID
- MS/17.07.80
- Conditions
- Chronic Knee Joint Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saphenous nerve block group | Experimental | Other: Saphenous nerve block groupPatients 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 | Experimental | Other: Platelet rich plasma groupPatients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Patient refusal.
- Bleeding disorders.
- Coagulation disorders.
- Local skin infection
- Current other problem in the affected extremity .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saphenous nerve block groupPatients 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 |
| Platelet rich plasma groupPatients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma | Other | Platelet rich plasma group |
Primary outcome
Pain scores
Time frame: For 6 months after intervention
The severity of pain will be assessed using a visual analog scale (VAS)
1 secondary outcome
Quality of life (QOL)
Time frame: For 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saphenous nerve block group and Platelet rich plasma group in people with Chronic Knee Joint Osteoarthritis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: For 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.