To find out the effect of pain neuroscience education on chronic pain in diabetic neuropathy and its impact on quality of life
Design
A concealed, randomized, single blinded, clinical trial with a parallel group design of 30 patients, will enrolled between September 2023 and November 2023.per and post treatment assessment will taken.
Settings and conduct
Study population will be selected from Neurology and Physical Therapy Department (OPD) of
Madinah Teaching Hospital (MTH),
Allied Hospital, Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Between age of 50 -70years
• Both Male and Female Genders
• Diabetic Neuropathy on basis of Monofilament testing (27)
• History of Diabetes more than 5years
• History of pain more than 6 months
• HBA1C(Hemoglobin A1c) ≥ 6.5%
Exclusion Criteria
• Individuals with diagnosed Neurological Disease/ All other neuropathies
• Wounds and Amputation in lower Extremity
• With Auditory disorder
Intervention groups
Group A will receive Pain Neuroscience Education with Conventional Therapy (TENS, stretching and strengthening exercises) which is interventional, and Group B will receive Conventional Therapy (TENS, stretching and strengthening exercises) which is Control Group.
Main outcome variables
Pain Intensity,
quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230731058981N1
Registration date:2023-09-05, 1402/06/14
Registration timing:registered_while_recruiting
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Anbreena Rasool
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8868220
Email address
anbreena.rasool@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-04, 1402/06/13
Expected recruitment end date
2023-11-15, 1402/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pain Neuroscience Education on Chronic Pain in Diabetic Neuropathy and its Impact on Quality of Life
Public title
Effect of Pain Neuroscience Education on Chronic Pain in Diabetic Neuropathy and its Impact on Quality of Life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between age of 50 -70years
Diabetic Neuropathy on basis of Monofilament testing
History of pain more than 6 months
HBA1C (Hemoglobin A1c) ≥ 6.5%
History of Diabetes more than 5 years
Both Male and Female Genders
Exclusion criteria:
Individuals with diagnosed Neurological Disease/ All other neuropathies
Wounds and Amputation in lower Extremity
With Auditory disorder
Age
From 50 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
All patients will be allocated in two groups (group A will be treatment group and group be will control group).Computer based random number generator will be used to assign each patient a number from 1 to 30, and then will assign those with odd numbers to group A and those with even numbers to group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
only participants will be blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The University of Faisalabad
Street address
The university of Faisalabad, main Sargodha road, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
TUF/Addl Reg/SB/l20
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E13.40
ICD-10 code description
Other specified diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Visual Analog scale (VAS) for pain intensity and Norfolk QOL-DN for quality of life will be measured as Baseline before start of Intervention and after 6 weeks at end of Intervention.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pain Neuroscience educational sessions will be given by help of Hand drawings and by leaflets, in Individual session. PNE session will be administered 2 times per week for 6 weeks by a single physiotherapist for 1 hour. Conventional Therapy (TENS, Stretching and strengthening exercises), High-Frequency TENS with 100Hz frequency, adjustable 200-400 micro seconds pulse width and 20 minutes duration. The intensity of stimulus will gradually increase until the patient can recognize the stimulation but was not make uncomfortable. Strengthening(stair climbing) and 2-4 repetition of stretching exercises (static stretch with 30 second hold), 1-3 sets on 2-3 alternative days of week for 6 week.
Category
Rehabilitation
2
Description
Control group: Group B will receive Conventional Therapy (TENS, stretching and strengthening exercises) which is Control Group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology and Physical Therapy Department (OPD) of Madinah Teaching Hospital (MTH)