Peripheral Nerve StimulationNCT06004882
Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
A study testing PNS therapy, Triamcinolone and Bupivacaine in people with Peripheral Nerve Stimulation and Genicular Nerves, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain: A standard steroid injection Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection PNS therapy in combination with a placebo injection Steroid injections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Stimulation, Genicular Nerves, Chronic Knee Pain
- What is being tested?
- PNS therapy, Triamcinolone and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic knee pain (baseline pain score >=4), seen at Pain Management Center at MD Anderson Cancer Center; if patient has bilateral knee pain, the side with the more severe knee pain will be treated first and counted towards the primary and secondary endpoints
- Patients between ages 18-85 years old
- Patient signed informed consent
Who cannot join
- Patients with cognitive dysfunction or without capacity to consent
- Patient with recent history (<6 months) of drug or alcohol abuse
- Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Patients with allergies to local anesthesia, steroids, or adhesives
- Patients who are on opioids for reasons other than knee pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Saba Javed, MD, 713-792-9530, sjaved@mdanderson.org
Saba Javed, MD
About this study
To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain:
- A standard steroid injection
- Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection
- PNS therapy in combination with a placebo injection
Steroid injections are given directly into the knee joints and are considered to be the standard therapy for chronic knee pain. In this study, the injection will be made of the steroid drugs triamcinolone and bupivacaine.
Read the detailed description
Primary Objectives:
- To compare the mean change in knee range of motion using goniometry from at 30 days (visit 2) from baseline among the three treatment arms.
Secondary Objectives:
- To compare the mean change in knee range of motion using goniometry at 60 days (visit 3) and 90 days (visit 4) from baseline among the three treatment arms.
- To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in morphine milliequivalent), and incidence of complications and adverse effects at 30 days, 60 days, and 90 days from baseline among the three treatment arms
- Being tested
- PNS therapy, Triamcinolone, Bupivacaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS therapyOther
PNS therapy-NS is a 60-day therapy targeting chronic pain. The procedure involves implanting a small piece of wire next to the nerve causing pain, and the wire is connected to an external device that is then used to apply electric pulses to the nerve, blocking pain signals, for 60 days
TriamcinoloneDrug
Given by Injection
BupivacaineDrug
Given by Injection
PlaceboOther
Given by Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (standard steroid injection) | Experimental | Participants will receive 1 standard steroid injection. Receives: Drug: Triamcinolone; Drug: Bupivacaine |
| Group 2 (PNS therapy plus 1 standard steroid injection). | Experimental | Participants will receive PNS therapy plus 1 standard steroid injection. Receives: Other: PNS therapy; Drug: Triamcinolone; Drug: Bupivacaine |
| Group 3 (PNS therapy plus 1 placebo injection) | Experimental | Participants will receive PNS therapy plus 1 placebo injection. Receives: Other: PNS therapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start10 Aug 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve StimulationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Javed, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004882
- Sponsor's protocol ID
- 2023-0041
- Other IDs
- NCI-2023-06513
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT06004882
- Acronym / sponsor ID
- 2023-0041
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Aug 2023 (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.
To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain:
- A standard steroid injection
- Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection
- PNS therapy in combination with a placebo injection
Steroid injections are given directly into the knee joints and are considered to be the standard therapy for chronic knee pain. In this study, the injection will be made of the steroid drugs triamcinolone and bupivacaine.
Detailed description
Primary Objectives:
- To compare the mean change in knee range of motion using goniometry from at 30 days (visit 2) from baseline among the three treatment arms.
Secondary Objectives:
- To compare the mean change in knee range of motion using goniometry at 60 days (visit 3) and 90 days (visit 4) from baseline among the three treatment arms.
- To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in morphine milliequivalent), and incidence of complications and adverse effects at 30 days, 60 days, and 90 days from baseline among the three treatment arms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (standard steroid injection) | Experimental | Drug: Triamcinolone, Drug: BupivacaineParticipants will receive 1 standard steroid injection. |
| Group 2 (PNS therapy plus 1 standard steroid injection). | Experimental | Other: PNS therapy, Drug: Triamcinolone, Drug: BupivacaineParticipants will receive PNS therapy plus 1 standard steroid injection. |
| Group 3 (PNS therapy plus 1 placebo injection) | Experimental | Other: PNS therapy, Other: PlaceboParticipants will receive PNS therapy plus 1 placebo injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with chronic knee pain (baseline pain score >=4), seen at Pain Management Center at MD Anderson Cancer Center; if patient has bilateral knee pain, the side with the more severe knee pain will be treated first and counted towards the primary and secondary endpoints
- Patients between ages 18-85 years old
- Patient signed informed consent
Key exclusion criteria (5 listed)
- Patients with cognitive dysfunction or without capacity to consent
- Patient with recent history (<6 months) of drug or alcohol abuse
- Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Patients with allergies to local anesthesia, steroids, or adhesives
- Patients who are on opioids for reasons other than knee pain
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 |
|---|---|---|
| PNS therapyPNS therapy-NS is a 60-day therapy targeting chronic pain. The procedure involves implanting a small piece of wire next to the nerve causing pain, and the wire is connected to an external device that is then used to apply electric pulses to the nerve, blocking pain signals, for 60 days | Other | Group 2 (PNS therapy plus 1 standard steroid injection)., Group 3 (PNS therapy plus 1 placebo injection) |
| TriamcinoloneGiven by Injection | Drug | Group 1 (standard steroid injection), Group 2 (PNS therapy plus 1 standard steroid injection). |
| BupivacaineGiven by Injection | Drug | Group 1 (standard steroid injection), Group 2 (PNS therapy plus 1 standard steroid injection). |
| PlaceboGiven by Injection | Other | Group 3 (PNS therapy plus 1 placebo injection) |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Time frame: through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Saba Javed, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNS therapy, Triamcinolone and Bupivacaine in people with Peripheral Nerve Stimulation and Genicular Nerves, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saba Javed, MD ((713) 792-9530, sjaved@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 (time frame: through study completion; an average of 1 year). 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 12 Aug 2026.