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

NCT06479577 | Recruiting

• 1 other identifier: REC/RCR/23/02101 Zara Tariq
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot; Diabetic Neuropathies

Keywords

diabetic neuropathies

Outcome Measures

Primary Outcomes (2)

• 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

  8th week

• 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

  8th week

Study Arms (2)

ultrasound

EXPERIMENTAL

therapeutic ultrasound 1MHZ continuous mode for 20 minutes

Other: ultrasound

high intensity laser therapy

ACTIVE COMPARATOR

approximately 905 nm super pulsed laser

Other: high intensity laser therapy

Interventions

ultrasound OTHER

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

ultrasound

high intensity laser therapy OTHER

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

high intensity laser therapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bahawalpur medical and dental hospital

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 33194943 BACKGROUND

• 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.

  PMID: 33810813 BACKGROUND

• 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.

  PMID: 32827852 BACKGROUND

• 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.

  PMID: 37604317 BACKGROUND

• 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.

  PMID: 32215272 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Aruba Saeed, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; Imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)