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

June 24, 2024 updated by: Riphah International University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Bahawalpur, Punjab, Pakistan, 63100
        • Recruiting
        • Bahawalpur medical and dental hospital
        • Contact:
        • Principal Investigator:
          • Zara Tariq, Ms (nmpt)
        • Sub-Investigator:
          • Hira Jabeen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound
therapeutic ultrasound 1MHZ continuous mode for 20 minutes
Other: ultrasound
ultrasound 1 MHZ continuous for 20 minute with routine physical therapy 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set
Active Comparator: high intensity laser therapy
approximately 905 nm super pulsed laser
Other: high intensity laser therapy
905 nm super pulsed laser 40 minute session 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8th week
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
8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Aruba Saeed, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR/23/02101 Zara Tariq

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot

Clinical Trials on ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe