Pain Neuroscience Education in Diabetic Neuropathy

• Sponsor: Riphah International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04721847
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Condition or Disease	Intervention/Treatment	Phase
Pain, Neuropathic; Diabetic Nephropathy	Other: Pain Neuroscience Education; Other: Conventional Physical therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Pain Neuroscience Education in Diabetic Neuropathy
• Actual Study Start Date: Aug 13, 2020
• Actual Primary Completion Date: Jul 28, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.
Active Comparator: Conventional Physical therapy Control group will be treated by TENS, stretching and strengthening exercises.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allied Hospital	Faisalabad	Punjab	Pakistan	46000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT04721847
• Other Study ID Numbers: REC/00752 Rameeza Warraich
• First Posted: Jan 25, 2021
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Pain; Neuropathy; Diabetes
• Additional relevant MeSH terms: Diabetic Neuropathies; Neuralgia; Diabetic Nephropathies

Study Results

No Results Posted as of Sep 23, 2021