Pain Neuroscience Education in Diabetic Neuropathy

NCT04721847 | Completed DMC

• 1 other identifier: REC/00752 Rameeza Warraich
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Conditions

Pain, Neuropathic; Diabetic Nephropathy

Keywords

Pain; Neuropathy; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Diabetic peripheral neuropathic pain impact measure

  6 weeks

Study Arms (2)

Pain Neuroscience Education

EXPERIMENTAL

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

Conventional Physical therapy

ACTIVE COMPARATOR

Control group will be treated by TENS, stretching and strengthening exercises.

Other: Conventional Physical therapy

Interventions

Pain Neuroscience Education OTHER

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.

Pain Neuroscience Education

Conventional Physical therapy OTHER

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.

Conventional Physical therapy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allied Hospital

Faisalabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Neuralgia; Diabetic Nephropathies; Pain; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mirza Obaid Baig, MSPT(NMR)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: August 13, 2020
• Primary Completion: July 28, 2021
• Study Completion: August 31, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)