US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathies; Diabetic Foot
• Interventions: Other: high intensity laser therapy; Other: ultrasound

• Registration Number: NCT06479577
• Lead Sponsor: Riphah International University

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 Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high intensity laser therapy	high intensity laser therapy	approximately 905 nm super pulsed laser
ultrasound	ultrasound	therapeutic ultrasound 1MHZ continuous mode for 20 minutes

Primary Outcome Measures

Name	Time	Method
michigan neuropathy screening instrument	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	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

Trial Locations

Locations (1)

Bahawalpur medical and dental hospital; 🇵🇰 Bahawalpur, Punjab, Pakistan