Diabetic Nephropathy Clinical Trial
Official title:
Effects of Pain Neuroscience Education in Diabetic Neuropathy
Verified date | September 2021 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
Status | Completed |
Enrollment | 74 |
Est. completion date | August 31, 2021 |
Est. primary completion date | July 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility | Inclusion Criteria: - History of diabetic = 5 years - HbA1C higher and equal to 6.5 % - Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) = 12 - Mini Mental State Examination (MMSE) score = 24 Exclusion Criteria: - Known neurological disorder - Foot ulcers/candidate of amputation - Hearing impaired |
Country | Name | City | State |
---|---|---|---|
Pakistan | Allied Hospital | Faisalabad | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric pain rating scale (NPRS) | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. | 6 weeks | |
Primary | Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) | Total score is 24. If score < 12, neuropathic mechanisms are unlikely to be contributing to the patient's pain. If score = 12, neuropathic mechanisms are likely to be contributing to the patient's pain. The S-LANSS has Cronbach a of .76 when completed unaided rising to a=.81 in neuropathic pain so this is reliable tool. | 6 weeks | |
Secondary | Diabetic peripheral neuropathic pain impact measure | 18 item DPNI is a reliable and valid Patient rating outcome measure disease impacts and treatment for DNP. Internal consistency ranged from 0.91 to 0.96 and test - retest from 0.84 to 0.91. All prespecified hypothesis for convergent and discriminant validity were met. | 6 weeks |
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