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Pain Neuroscience Education in Diabetic Neuropathy

Effects of Pain Neuroscience Education in Diabetic Neuropathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04721847
Enrollment
74
Registered
2021-01-25
Start date
2020-08-13
Completion date
2021-08-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Pain, Neuropathic

Keywords

Pain, Neuropathy, Diabetes

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.

Interventions

OTHERPain 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.

OTHERConventional 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.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numeric pain rating scale (NPRS)6 weeksThe 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 weeksTotal 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

MeasureTime frameDescription
Diabetic peripheral neuropathic pain impact measure6 weeks18 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026