Pain Neuroscience Education in Diabetic Neuropathy

Study Overview
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Brief Summary
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To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Detailed Description
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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.

Official Title
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Effects of Pain Neuroscience Education in Diabetic Neuropathy

Conditions
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Pain, Neuropathic, Diabetic Nephropathy

Intervention / Treatment
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* Other: Pain Neuroscience Education
* Other: Conventional Physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Neuroscience Education<br>Pain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group | Other: Pain Neuroscience Education<br>* In first part educational content will be designed to be given in group of patients in six sessions by PNE booklet. The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week. Final session will be given to solve doubts, and to provide additional information to the educational program. Book for additional material will be delivered to participants.<br>|
| Active Comparator: Conventional Physical therapy<br>Control group will be treated by TENS, stretching and strengthening exercises. | Other: Conventional Physical therapy<br>* Control group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises. Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 α of .76 when completed unaided rising to α=.81 in neuropathic pain so this is reliable tool. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Neuropathy, Diabetes