Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

NCT ID: NCT05250999

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2021-12-15

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.

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Skin stretch sensory stimuli

Skin stretch sensory stimuli along with conventional physiotherapy

Group Type: EXPERIMENTAL

Skin stretch sensory stimuli

Intervention Type: 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.

Transcutaneous Electrical Nerve Stimulation

Transcutaneous electrical nerve stimulation along with conventional physiotherapy

Group Type: EXPERIMENTAL

Transcutaneous Electrical nerve stimulation

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Aabroo, PPDPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

District Head Quarter Hospital

Okara, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/Lhr/21/0213 Sobia Younas

Identifier Type: -

Identifier Source: org_study_id