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Pain Neuroscience Education in Diabetic Neuropathy

Primary Purpose

Pain, Neuropathic, Diabetic Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pain Neuroscience Education
Conventional Physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neuropathic focused on measuring Pain, Neuropathy, Diabetes

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allied Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neuroscience Education

Conventional Physical therapy

Arm Description

Pain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 19, 2021
Last Updated
September 17, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04721847
Brief Title
Pain Neuroscience Education in Diabetic Neuropathy
Official Title
Effects of Pain Neuroscience Education in Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic, Diabetic Nephropathy
Keywords
Pain, Neuropathy, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
Pain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group
Arm Title
Conventional Physical therapy
Arm Type
Active Comparator
Arm Description
Control group will be treated by TENS, stretching and strengthening exercises.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
6 weeks
Title
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Diabetic peripheral neuropathic pain impact measure
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT(NMR)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Hospital
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Neuroscience Education in Diabetic Neuropathy

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