Regulating Urine pH Levels to Alleviate Chronic Joint Pain

• Status: Withdrawn
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine the causal relationship between regulating urine pH levels between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that maintenance of an alkaline urinary pH will result in a decrease in personally reported levels of chronic joint pain using a citrate treatment regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso
• Treatments: Citric Acid; Sodium Citrate

Criteria

Inclusion Criteria:

1. Presence of joint pain of perceived inflammatory and non-inflammatory origin for more than six months. More specifically:

• Subjects with osteoarthritis (OA) of the knee will be preferred for inclusion in this study.

• Subjects with other joint pain history will be included pursuant on approval from Dr. Miller or Dr. Pema.

2. Age 21 to 80 years old and otherwise in good health (excluding the joint pain).

3. Able to understand and comply with the assigned urine alkalinization instructions.

4. Has a working and reliable telephone number for continued contact as necessary during the study.

5. Ability to obtain X-rays of the affected joint. Imaging of the painful joint will be necessary at the beginning of the study for baseline considerations; if images from the last 6 months are available, no new imaging would be necessary.

6. Ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) or can obtain documentation of recent lab tests that have been taken within one month prior to enrollment.

7. Ability to obtain lab tests at 3 and 6 months during participation in the study.

Exclusion Criteria:

1. Presence of joint pain with known joint osseous changes.

2. Pregnant or lactating women will not be enrolled in the study.

3. Positive medical history of:

• Diabetes

• Neuropathies

• Gout

• Psychiatric diseases and conditions, including anxiety, depression, PTSD, distress

• Psychosocial abnormalities

• Dementia or other memory disturbances

• Alcoholism or substance abuse

• Renal failure and/or abnormal renal function (kidney disease or dysfunction). Specifically, Creatinine (Creat) values that are over 1.2mg/dL and Urea Nitrogen (BUN) values that are over 22mg/dL are considered abnormal.

• No history of cardiovascular disease, intestinal angina or arrhythmias

• No history of sodium restrictions

• Pt. should not be taking medications which produce pain such as angiotensin converting enzyme (ACE) inhibitors and Statins (Lisinopril, Quinapril, Ramipril)

4. Does not have reliable telephone communication.

5. Does not have the ability to obtain an X-ray and does not have the ability to obtain documentation of a recent X-ray within the last six months.

6. Does not have the ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) and does not have the ability to obtain documentation of recent lab tests that have been taken within one month prior to enrollment.

7. Does not have the ability to obtain lab tests at 3 and 6 months during participation in the study.