The aim of the study is to compare the effects of Whole-body vibration and PNF(proprioceptive neuromuscular facilitation) techniques on pain, sensorimotor functions and balance in diabetic peripheral neuropathy
Design
Two arm parallel group randomised trial with single blinded trial with 36 participants with diabetic pheripheral neuropathy,group A recieve Whole-body vibration and grouo B recieve PNF(proprioceptive neuromuscular facilitation) technique after pre and post outcome assessment , enrolled between july 2024 to december 2024.
Settings and conduct
This study was conducted at Al-Shifa clinic Ahmed pur east from july 2024 to December 2024'.
Participants/Inclusion and exclusion criteria
Inclusion criteria: HbA1c level should be >154ml/dL, Age beteeen 45 to 60, both male and femle participants, presence of sensorimoter dysfunction like pain and numbness,persisted pain for 4-6 weeks,Exclusion criteria: diabetic ulcers, high surgical risks,participants with cardiac conditions, neuropathic symptoms other than included in the study.
Intervention groups
Group A recieves Whole-body vibration technique by standing on a vibratory platform to get vibrational stimulation. Group B recieves PNF(proprioceptive neuromuscular facilitation) techniques where the participants' limbs are moved through diagonal patterns to achieve the desired gaol. this intervention is designed for three times a week for eight weeks
Main outcome variables
primary outcome variable: pain intensity measure with Numeric pain rating scale,
secondary outcome variable: sensorimotor functions measured using the Leeds Assessment of neuropathic Symptoms and Signs (LANSS) scale
balance measured with Berg Balance scale (BBS)
General information
Reason for update
Acronym
PNF(proprioceptive neuromuscular facilitation)
IRCT registration information
IRCT registration number:IRCT20250103064262N1
Registration date:2025-01-30, 1403/11/11
Registration timing:retrospective
Last update:2025-01-30, 1403/11/11
Update count:0
Registration date
2025-01-30, 1403/11/11
Registrant information
Name
Mehjabeen Ali
Name of organization / entity
Riphah international university
Country
Pakistan
Phone
+92 300 0720887
Email address
talhaalibaig786@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-12-01, 1403/09/11
Actual recruitment start date
2024-07-01, 1403/04/11
Actual recruitment end date
2024-11-15, 1403/08/25
Trial completion date
2024-11-24, 1403/09/04
Scientific title
Comparative effects of Whole-body vibration and PNF techniques on pain,sensorimotor function and balance in diabetic peripheral neuropathy
Public title
Comparison of effects of whole body vibration and PNF techniques on pain, sensorimotor function and balance in diabetic peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
HbA1c level should be >154ml/dL
Both genders
Age between 45 to 60 years
Presence of sensorimotor dysfunction including pain and numbness
<45 score of berg balance score
Patient should be able to comprehend and fulfill the command
Pain persisting fom 4 to 6 weeks
Non-pregnant adults
Exclusion criteria:
Patients with cardiac conditon
Depression that needs treatment
High surgical risks
Diabetic ulcers
Neuropathic pain other than included in the study
Age
From 45 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
22
Hba1c is required
Actual sample size reached:
36
More than 1 sample in each individual
Actual sample size in each individual:
18
HbA1c test is required before further assessment
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a randomized clinical trial. A total of 36 patients will be recruited according to the inclusion and exclusion criteria according to convenience sampling into two intervention groups. Patients will be divided into Group A(n=18) and Group B(n=18). Group A will recieve Whole-body vibration therapy and Group B will recieve PNF techniques with conventional treatment. All participants will receive interventions for 35-40 mintues per session, three times a week for eight weeks. For pre and post evaluation of all participants Berg Balance Scale, LANSS scale and Numeric pain rating scale will be used. Data will analysed by using SPSS (statistical package for social sciences) 23 version.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study employes a single-blinded design, where participants are unaware of their treatment allocation. Participants are randomly assigned to either the Whole-body vibration group or the proprioceptive neuromuscular facilitation PNF technique group. The researcher knows which treatment each participant receives but will use standardized tools to assess outcomes and minimize bias. This design helps ensure the study results are reliable and accurate.
Comparative effects of Whole-body vibration and PNF techniques on pain,sensorimotor fucntions and balance in diabetic peripheral neuropathy
Secondary trial Id
81143
Registration date
2025-01-05, 1403/10/16
Ethics committees
1
Ethics committee
Name of ethics committee
Reseach Ethics Committee (REC)
Street address
25 Raza Saeed RD, bhabra Block M Gulberg 3, Lahore
City
Lahore
Postal code
54660
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
REC/RCR&AHS/24/0224
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus is a serious health disease that causes a person's blood sugar level to be high. It happens when your body cannot make enough insulin or does not respond to the insulin in the body. The most common and serious complication of diabetes mellitus is diabetic peripheral neuropathy in whic the nerves in the peripheries get damaged and produce symptoms like pain, numbness, tingling and burning sensations.The prevalance of diabetic neuropathy is between 6% to 51% in older adults depending on age, duration and sugar level control.
ICD-10 code
E08.42
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic polyneuropathy
Primary outcomes
1
Description
Pain reduction
Timepoint
Before intervention and 2,4 and 8th week and after intervention
Method of measurement
Numeric pain rating scale
Secondary outcomes
1
Description
Balance improvement
Timepoint
2, 4 and 6 week
Method of measurement
Berg balance score
Intervention groups
1
Description
Intervention group: the intervention group is divided into two groups. Group A will receive whole-body vibration technique in which we will use a whole-body vibration machine. the participants will stand on the vibrating platform to receive vibrational stimulation
Category
Rehabilitation
2
Description
Intervention group: the Group B will receive PNF technique in which Diagonal patterns will be used where the therapist will move the participants' limbs through diagonal patterns helping to improve proprioception and neuromuscular control