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Clinical Trials/NCT06479577
NCT06479577RecruitingNot Applicable

Comparative Effects of Therapeutic Ultrasound and High Intensity Laser Therapy on Neuropathic Pain ,Strength and Quality of Life in Diabetic Foot

Riphah International University1 site in 1 country46 target enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
46
Locations
1
Primary Endpoint
michigan neuropathy screening instrument

Study Overview

Brief Summary

To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot

Detailed Description

therapeutic ultrasound and laser therapy with routine physical therapy are used to improve neuropathic pain and foot related quality of life. the scarcity of evidence regarding the application of high intensity laser therapy necessitates a comprehensive investigation. The effects of HILT and comparative effects with ultrasound remains largely unexplored in diabetic peripheral neuropathy

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with type 2 diabetes.
  • •Diabetic Patients of age 50 to 75 years.
  • •Diabetic patient of Both genders
  • •Diagnosed Diabetes Mellitus with at least 7 years of duration
  • •Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for ≥6 months
  • •DNS (Diabetic neuropathy symptoms questionnaire) score greater than 4 (90 percent probability of neuropath

Exclusion Criteria

  • •Pregnant females
  • •Lower limb Amputated patients
  • •History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus.
  • •Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapses and lumbar spine associated radiculopathy.
  • •History of any low back surgeries and lower limb surgeries
  • •Patient with malignancy. Patient with epilepsy
  • •Patient with hemophilia
  • •Patient with pacemaker, metal implants prosthesis and internal fixation screws.
  • •Patient with severe cervical and lumbar neuropathy, rheumatoid arthritis, hereditary neuropathy
  • •Patient with a history of neurosurgery

Arms & Interventions

ultrasound

Experimental

therapeutic ultrasound 1MHZ continuous mode for 20 minutes

Intervention: ultrasound (Other)

high intensity laser therapy

Active Comparator

approximately 905 nm super pulsed laser

Intervention: high intensity laser therapy (Other)

Outcomes

Primary Outcomes

michigan neuropathy screening instrument

Time Frame: 8th week

MNSI is designed to screen for the presence of diabetic neuropathy the first part consist of 15 self administered questions on foot sensations ,pain ,numbness etc second part is brief physical examination of feet

foot and ankle disability index

Time Frame: 8th week

FADI is designed to assess functional limitations related to foot and ankle conditions it has 26 items each item scored from 0 -4 FADI has totel 104 points

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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