Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00623961
Other study ID # 2006-0425
Secondary ID
Status Completed
Phase N/A
First received February 14, 2008
Last updated January 12, 2015
Start date April 2007
Est. completion date February 2011

Study information

Verified date June 2010
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study seeks to validate clinically evoked or obtained objective pain signs with the patient's corresponding quantified subjective pain symptoms. This will allow for validation of objective clinical pain signs to then be used to begin to classify patients with pain based on symptoms and signs. This then can be used as a basis for further study of neuropathic pain mechanisms in human patients.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must be 18 years of age and older, and able to provide informed consent and communicate in English. Pain rating inclusion criteria will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable. This rating is based on the numeric pain rating scale (NPRS).

- PHN - Subjects with PHN will have a history of pain of at least 6 months duration in the area that was the site of a zoster rash resulting in nerve injury. In most cases, subjects experience a number of sensory abnormalities in the affected area, ranging from pain to numbness, and various degrees of hypersensitivity. Subjects with PHN must otherwise be in stable health. Pain rating inclusion criteria for PHN subjects will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable.

- PDN - Subjects with diabetes mellitus and neuropathy who have a history of pain, predominantly in the lower extremities, of at least 6 months duration qualify for the diagnosis of PDN for purposes of this study. In most cases PDN is due to small fiber neuropathy, so physical examination should yield sensory abnormalities, such as pain, paresthesiae and numbness. Motor function and stretch reflex abnormalities are common but not necessary for inclusion. PDN patients in whom large fiber functions are affected, experience weakness and decreased or absent stretch reflexes, respectively, and are eligible for this study. Other causes of neuropathy will be excluded. PDN patients with pain rating of greater than 3 up to 9 on 0-10 scale will be included.

- SCI pain - Subjects with SCI and pain of at least 6 months duration will be invited to participate. In most cases, these subjects' sensory, motor and stretch reflex abnormalities are consistent with SCI. Sensory findings range form complete loss of sensation to preservation of all sensory modalities. Motor findings range from mild weakness to complete paralysis. Stretch reflexes are most frequently increased though in a few patients they can be absent. Based on the constellation of sensory and motor findings in particular patients, diagnosis of complete versus incomplete SCI is made. In this study we will study patients with incomplete SCI who have pain at level of injury or below level of injury, or both. Subjects with SCI who have pain rating of greater than 3 up to 9 on 0-10 scale will be included.

Exclusion Criteria:

- Patients with pain due to disorders other than PDN, PTN, or SCI, as well as unknown causes, will be excluded.

- Patients with neuropathies from causes such as vasculitis, demyelinating polyneuropathies, HIV-associated neuropathy, and paraneoplastic and post-infectious neuropathies will be excluded.

- Patients with chemotherapy-induced neuropathy will be excluded.

- Patients who suffer from pain due to different pain mechanisms will be excluded.

- Patients with other pain (at a different site) that is more severe than their PDN or PTN pain will be excluded.

- Patients with a history of recent or ongoing alcohol or other drug addiction disorders (as self-reported or previously documented in the medical record) will be excluded.

- Patients who are determined to have cognitive and reading impairments which would preclude them from completing questionnaires will be excluded.

- Patients whose chronic medical and psychiatric comorbidities are not under optimal control, or who are currently experiencing an acute exacerbation of a medical or psychiatric comorbidity, will be excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States UW Hospitals and Clinics Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of neuropathic pain sensory sign and corresponding symptoms Two weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Recruiting NCT05863793 - Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy N/A
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2