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Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Skin stretch sensory stimuli
Transcutaneous Electrical nerve stimulation
Control Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Diabetic Neuropathy, TENS, Kinesiotape, Balance

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants age ranged from 45 to 80 years' old
  • Both genders.
  • patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system
  • HbA1c levels
  • peripheral neuropathic pain of >6 months' duration involving the lower extremities
  • history of diabetes treated with diet, oral hypoglycemic or insulin therapy
  • lower extremity symptoms such as muscle pain, decrease in sensations, Achilles tendon reflex, joint position sense of thumb
  • Sensory polyneuropathy because of type 2 diabetic diseases
  • Ability to walk household distance without assistance or with the use of assistive device such as cane.

Exclusion Criteria:

  • Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM.
  • Previous history of knee or back surgery
  • Lower extremity arthritis that prevents standing
  • History of cardiovascular problems such as angina, MI
  • Symptomatic postural hypotension
  • Foot ulceration.
  • Skin problems such as rashes etc.

Sites / Locations

  • District Head Quarter Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Skin stretch sensory stimuli

Transcutaneous Electrical Nerve Stimulation

Control Group

Arm Description

Skin stretch sensory stimuli along with conventional physiotherapy

Transcutaneous electrical nerve stimulation along with conventional physiotherapy

Conventional physiotherapy included balance exercises, static exercise and dynamic exercise.

Outcomes

Primary Outcome Measures

Berg Balance Scale
Berg balance scale is used to quantitively evaluate functional balance in older patients with balance disorders. It is a reliable, valid and sensitive to change scale, that include 14 items, maximum score 56 and required 20-40 minutes for completion. The score showed the patient's ability to control postural balance in which maximum score showed a good functional balance.
Toronto Clinical Neuropathy scoring system
TCNS is a sensitive scoring system to diagnose diabetic neuropathy. The Toronto Clinical Neuropathy Score (TCNS) is for the diagnosis and staging of diabetic neuropathy. The score ranges from a minimum of 0 (no neuropathy) to a maximum of 19 points, and incorporates sensory and motor symptoms, as well lower limb sensory and reflex findings, and symptoms such as numbness, tingling, pain, weakness, ataxia and upper limb symptoms.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
February 20, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05250999
Brief Title
Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy
Official Title
Comparative Effects of Skin Stretch Sensory Stimuli and Transcutaneous Electrical Nerve Stimulation on Balance in Patients With Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
December 15, 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
No

5. Study Description

Brief Summary
The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. The subjects were divided into 3 groups, 15 subjects in skin stretch sensory stimuli group, 15 subjects in TENS group and 16 subjects in control group. Study duration was of 6 month. Sampling technique applied was convenient non-probability sampling. Patients aged range from 45 to 80 years, having moderate peripheral neuropathy, and decrease sensations were included. Tools used in this study were Berg Balance scale and Toronto clinical neuropathy score system. Data was being analyzed through Spss 21.
Detailed Description
Literature shows that various studies was done on diabetic patients for pain reduction, increase proprioception, improve muscle function and muscle recruitment by using kinesio tape and transcutaneous electrical nerve stimulation. There is particularly limited literature available on the effects of skin stretch sensory stimuli on balance in DN patients. Therefore, based on the literature study, there is crucial need for studying the effects of skin stretch sensory stimuli and TENS as a treatment approach. Thus, the current study will be an attempt to know the results of skin stretch sensory stimuli and TENS in DN patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Diabetic Neuropathy, TENS, Kinesiotape, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin stretch sensory stimuli
Arm Type
Experimental
Arm Description
Skin stretch sensory stimuli along with conventional physiotherapy
Arm Title
Transcutaneous Electrical Nerve Stimulation
Arm Type
Experimental
Arm Description
Transcutaneous electrical nerve stimulation along with conventional physiotherapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy included balance exercises, static exercise and dynamic exercise.
Intervention Type
Other
Intervention Name(s)
Skin stretch sensory stimuli
Intervention Description
Skin stretch sensory stimuli will be exerted by a piece of kinesio tape that as applied above right and left lateral malleolus on posterior leg and on both side of spinous process of second thoracic vertebrae till 15cm below for 24 hours a day, 5 days/ week for 6 weeks along with conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical nerve stimulation
Intervention Description
TENS will be applied to patient while in sitting position for 30 minutes, twice a week, and for 6 weeks (12 treatment sessions along with conventional physiotherapy). A maximum of 25 m amp electrical stimulation with a biphasic square-wave pattern and a pulse width of 0.5ms in a continuous duty cycle will be used. The intensity of the electrical stimulation will be regulated to the high tolerable level without initiating muscle contractions.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
This program include balance exercises performed twice a week for 6 weeks, which consists of balance, progressive strength, and functional mobility training. Static exercise consists of heel and toe raises, one-legged stance for each limb, weight shifting forward, backward, sideward and diagonally, and turning the head to the left and then to the right keeping the feet together. This exercise comprises two 10-min sessions each, with eyes opened and eyes closed, respectively. Dynamic exercise comprises of walking, step-ups, and bipedal jumps for 10 min. Progressive balance exercises comprises of narrow walking, walking backward, walking sideward, stepping over obstacles, passing, throwing and catching a ball.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Berg balance scale is used to quantitively evaluate functional balance in older patients with balance disorders. It is a reliable, valid and sensitive to change scale, that include 14 items, maximum score 56 and required 20-40 minutes for completion. The score showed the patient's ability to control postural balance in which maximum score showed a good functional balance.
Time Frame
6th week
Title
Toronto Clinical Neuropathy scoring system
Description
TCNS is a sensitive scoring system to diagnose diabetic neuropathy. The Toronto Clinical Neuropathy Score (TCNS) is for the diagnosis and staging of diabetic neuropathy. The score ranges from a minimum of 0 (no neuropathy) to a maximum of 19 points, and incorporates sensory and motor symptoms, as well lower limb sensory and reflex findings, and symptoms such as numbness, tingling, pain, weakness, ataxia and upper limb symptoms.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants age ranged from 45 to 80 years' old Both genders. patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system HbA1c levels peripheral neuropathic pain of >6 months' duration involving the lower extremities history of diabetes treated with diet, oral hypoglycemic or insulin therapy lower extremity symptoms such as muscle pain, decrease in sensations, Achilles tendon reflex, joint position sense of thumb Sensory polyneuropathy because of type 2 diabetic diseases Ability to walk household distance without assistance or with the use of assistive device such as cane. Exclusion Criteria: Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM. Previous history of knee or back surgery Lower extremity arthritis that prevents standing History of cardiovascular problems such as angina, MI Symptomatic postural hypotension Foot ulceration. Skin problems such as rashes etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo, PPDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Head Quarter Hospital
City
Okara
State/Province
Punjab
ZIP/Postal Code
56300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

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