Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

NCT05250999 | Completed

• 1 other identifier: REC/Lhr/21/0213 Sobia Younas
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy; TENS; Kinesiotape; Balance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Skin stretch sensory stimuli

EXPERIMENTAL

Skin stretch sensory stimuli along with conventional physiotherapy

Other: Skin stretch sensory stimuli

Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

Transcutaneous electrical nerve stimulation along with conventional physiotherapy

Other: Transcutaneous Electrical nerve stimulation

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

Skin stretch sensory stimuli OTHER

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.

Skin stretch sensory stimuli

Transcutaneous Electrical nerve stimulation OTHER

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.

Transcutaneous Electrical Nerve Stimulation

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

District Head Quarter Hospital

Okara, Punjab Province, 56300, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Transcutaneous Electric Nerve Stimulation; Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sara Aabroo, PPDPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: February 22, 2022
• Study Start: July 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)