Pain Neuroscience Education in Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Nephropathy; Pain, Neuropathic
• Interventions: Other: Pain Neuroscience Education; Other: Conventional Physical therapy

• Registration Number: NCT04721847
• Lead Sponsor: Riphah International University

Brief Summary

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Detailed Description

Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.

Study Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Primary Completion: 2021-07-28
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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Exclusion Criteria

• Known neurological disorder
• Foot ulcers/candidate of amputation
• Hearing impaired

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Neuroscience Education	Pain Neuroscience Education	Pain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group
Conventional Physical therapy	Conventional Physical therapy	Control group will be treated by TENS, stretching and strengthening exercises.

Primary Outcome Measures

Name	Time	Method
Numeric pain rating scale (NPRS)	6 weeks	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.
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)	6 weeks	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 α of .76 when completed unaided rising to α=.81 in neuropathic pain so this is reliable tool.

Secondary Outcome Measures

Name	Time	Method
Diabetic peripheral neuropathic pain impact measure	6 weeks	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.

Trial Locations

Locations (1)

Allied Hospital; 🇵🇰 Faisalabad, Punjab, Pakistan