Clinical trial NCT06479577: US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot
Official title: Comparative Effects of Therapeutic Ultrasound and High Intensity Laser Therapy on Neuropathic Pain ,Strength and Quality of Life in Diabetic Foot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Diabetic Neuropathies
Keywords: diabetic neuropathies
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: michigan neuropathy screening instrument
timeFrame: 8th week
measure: foot and ankle disability index
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Bahawalpur medical and dental hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.