Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title:

Comparative Effects of Skin Stretch Sensory Stimuli and Transcutaneous Electrical Nerve Stimulation on Balance in Patients With Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250999
• Other study ID #: REC/Lhr/21/0213 Sobia Younas
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Skin stretch sensory stimuli
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.
• Transcutaneous Electrical nerve stimulation
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.
• Control Group
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.

Locations

Country	Name	City	State
Pakistan	District Head Quarter Hospital	Okara	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6th week
Primary	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.	6th week