Clinical trial NCT05250999: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: Diabetic Neuropathy
TENS
Kinesiotape
Balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 6th week
measure: Toronto Clinical Neuropathy scoring system
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Okara
country: Pakistan
facility: District Head Quarter Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sara Aabroo, PPDPT
role: PRINCIPAL_INVESTIGATOR
References: