Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Other: Skin stretch sensory stimuli; Other: Control Group; Other: Transcutaneous Electrical nerve stimulation

• Registration Number: NCT05250999
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2021-07-15
• Primary Completion: 2021-09-15
• Study Completion: 2021-12-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Last Update Submitted: 2022-02-20
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin stretch sensory stimuli	Skin stretch sensory stimuli	Skin stretch sensory stimuli along with conventional physiotherapy
Control Group	Control Group	Conventional physiotherapy included balance exercises, static exercise and dynamic exercise.
Transcutaneous Electrical Nerve Stimulation	Transcutaneous Electrical nerve stimulation	Transcutaneous electrical nerve stimulation along with conventional physiotherapy

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	6th week	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	6th week	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.

Trial Locations

Locations (1)

District Head Quarter Hospital; 🇵🇰 Okara, Punjab, Pakistan