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Comparing the effects of local heat therapy and progressive muscle relaxation technique on neuropathic pain, fatigue, and quality of life in diabetic patients with diabetic neuropathy

Comparing the effects of local heat therapy and progressive muscle relaxation technique on neuropathic pain, fatigue, and quality of life in diabetic patients with diabetic neuropathy: A clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250109064332N1
Enrollment
90
Registered
2025-04-02
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes. Type 2 diabetes mellitus with neurological complications

Interventions

Intervention 1: Intervention group: For patients in the local heat therapy intervention group, a hot pack will be used, which is a special bag with a standard size of 35×25 made of cotton. The hot pac

Sponsors

Gonabad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: Type 2 diabetes with peripheral neuropathy or a score of more than one using the NSS criteria Patient's willingness and written informed consent to participate in the study Neuropathic pain (score of one or more) according to the visual pain scale No history of disease or condition that affects neuropathy (stroke, multiple sclerosis, gout, Parkinson's, spinal cord injury, Guillain-Barré, rheumatic disease, thrombosis and vascular disorder) based on medical records and patient report Consciousness and ability to speak and communicate to report the severity of clinical symptoms during examination and examination Age under 60 years No cardiac arrhythmias according to the doctor's examination and confirmation No history of addiction to narcotics or strong painkillers according to the patient's statement No complete sensory impairment in the distal lower extremities and the presence of wounds and lesions at the site of heat therapy No The presence of fractures and traumatic injuries leading to sensory and motor impairments in the lower limbs

Exclusion criteria

Exclusion criteria: Unwillingness to continue cooperation during the study The occurrence of any disorder or special condition during the study that prevents the use of heat therapy or progressive muscle relaxation technique. The necessity of using any unforeseen pharmacological and non-pharmacological intervening factors affecting pain, fatigue, and quality of life during the study The occurrence of situational crises affecting the quality of life, such as divorce, death of relatives, bankruptcy.

Design outcomes

Primary

MeasureTime frame
Neuropathic Pain. Timepoint: Pre-intervention, Week 4, Week 6. Method of measurement: Visual Analogue Scale (VAS).;Fatigue. Timepoint: Pre-intervention, Week 4, Week 6. Method of measurement: Functional Assessment of Chronic Illness Treatment-Fatigue Scale (FACIT-F).;Quality of Life. Timepoint: Pre-intervention, Week 4, Week 6. Method of measurement: Diabetic Quality of Life Questionnaire (DQOL).

Secondary

MeasureTime frame
Symptoms of diabetic neuropathy. Timepoint: Pre-intervention, week 4, week 6. Method of measurement: Diabetic Neuropathy Symptom Score (NSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactErfan Pourshahri

Gonabad University of Medical Sciences

e.pourshahri@yahoo.com+98 51 5722 4946

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026