- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721847
Pain Neuroscience Education in Diabetic Neuropathy
September 17, 2021 updated by: Riphah International University
Effects of Pain Neuroscience Education in Diabetic Neuropathy
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Faisalabad, Punjab, Pakistan, 46000
- Allied Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: 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.
|
6 weeks
|
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Time Frame: 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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetic peripheral neuropathic pain impact measure
Time Frame: 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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2020
Primary Completion (Actual)
July 28, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
January 19, 2021
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 25, 2021
Study Record Updates
Last Update Posted (Actual)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00752 Rameeza Warraich
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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