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Status unknownNCT06479577Updated Jun 28, 2024

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

An interventional study of ultrasound and high intensity laser therapy in Diabetic Foot and Diabetic Neuropathies, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by Riphah International University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2024, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Diabetic Foot
  • Diabetic Neuropathies

Keywords

  • diabetic neuropathies
03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.

This study's planned enrollment of 46 is below the median of 60 across 845 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    ultrasound

    therapeutic ultrasound 1MHZ continuous mode for 20 minutes

    Other: ultrasound

  • Active comparator
    high intensity laser therapy

    approximately 905 nm super pulsed laser

    Other: high intensity laser therapy

Interventions

  • Otherultrasound

    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

  • Otherhigh 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

06

What researchers measure

Primary outcomes

  1. michigan neuropathy screening instrument

    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

    Time frame: 8th week

  2. foot and ankle disability index

    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

    Time frame: 8th week

07

Study locations

1 of 1 sites recruiting
  • Bahawalpur medical and dental hospital
    Bahawalpur, Punjab Province 63100, Pakistan
    • Hira Jabeen · Contact · hira.jabeen@riphah.edu.pk · 03234116506
    • Zara Tariq, Ms (nmpt) · Principal investigator
    • Hira Jabeen, Phd · Sub investigator
    Recruiting
08

References and documents

Publications

  • Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020. PubMed 33194943 ↗
  • Lin L, Li J, Lin J, Tang S, Li Y. Effectiveness and safety of low-level laser therapy in diabetic peripheral neuropathy: a protocol for a systematic review and meta-analysis. Syst Rev. 2021 Apr 2;10(1):96. doi: 10.1186/s13643-021-01656-y. PubMed 33810813 ↗
  • Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2020 Dec;50:102220. doi: 10.1016/j.msksp.2020.102220. Epub 2020 Jul 24. PubMed 32827852 ↗
  • Eun IS, Oh YS, Kim J, Jang W. Reliability and Validity of the Korean Version of Foot and Ankle Disability Index. J Foot Ankle Surg. 2024 Jan-Feb;63(1):33-35. doi: 10.1053/j.jfas.2023.08.007. Epub 2023 Aug 19. PubMed 37604317 ↗
  • Seyedizadeh SH, Cheragh-Birjandi S, Hamedi Nia MR. The Effects of Combined Exercise Training (Resistance-Aerobic) on Serum Kinesin and Physical Function in Type 2 Diabetes Patients with Diabetic Peripheral Neuropathy (Randomized Controlled Trials). J Diabetes Res. 2020 Mar 6;2020:6978128. doi: 10.1155/2020/6978128. eCollection 2020. PubMed 32215272 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06479577
Responsible party
Sponsor
First posted
Jun 28, 2024
Start date
Feb 1, 2024
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Jun 28, 2024

Study contacts

Imran Amjad, Phd
Contact
Imran.amjad@riphah.edu.pk
03324390125
Aruba Saeed, Phd
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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