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

NCT ID: NCT06479577

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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

Conditions

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Diabetic Foot Diabetic Neuropathies

Keywords

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diabetic neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ultrasound

therapeutic ultrasound 1MHZ continuous mode for 20 minutes

Group Type EXPERIMENTAL

ultrasound

Intervention Type 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

high intensity laser therapy

approximately 905 nm super pulsed laser

Group Type ACTIVE_COMPARATOR

high intensity laser therapy

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aruba Saeed, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Bahawalpur medical and dental hospital

Bahawalpur, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Amjad, Phd

Role: CONTACT

Phone: 03324390125

Email: [email protected]

Facility Contacts

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Hira Jabeen

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33194943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33810813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32827852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37604317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32215272 (View on PubMed)

Other Identifiers

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REC/RCR/23/02101 Zara Tariq

Identifier Type: -

Identifier Source: org_study_id