Pain Neuroscience Education in Diabetic Neuropathy

Diabetic Nephropathy Clinical Trial

Official title:

Effects of Pain Neuroscience Education in Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721847
• Other study ID #: REC/00752 Rameeza Warraich
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Diabetic Neuropathies
• Neuralgia
• Pain, Neuropathic

Intervention

Other:
• Pain Neuroscience Education
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.
• Conventional Physical therapy
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.

Locations

Country	Name	City	State
Pakistan	Allied Hospital	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

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