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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06513 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain:
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.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (standard steroid injection) | Experimental | Participants will receive 1 standard steroid injection. |
|
| Group 2 (PNS therapy plus 1 standard steroid injection). | Experimental | Participants will receive PNS therapy plus 1 standard steroid injection. |
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| Group 3 (PNS therapy plus 1 placebo injection) | Experimental | Participants will receive PNS therapy plus 1 placebo injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNS therapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 | through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saba Javed, MD | Contact | (713) 792-9530 | sjaved@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Saba Javed, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Triamcinolone | Drug | Given by Injection |
|
| Bupivacaine | Drug | Given by Injection |
|
| Placebo | Other | Given by Injection |
|
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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