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Investigation of the Impact of a Lower Back Recovery Device on Sleep Quality and Blood Glucose Levels in Diabetic Patients with Knee Osteoarthritis

Investigating the Impact of a Lower Back and Knee Recovery Device on Sleep Quality and Blood Glucose Levels in Diabetic Patients with Knee Osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191027045257N7
Enrollment
74
Registered
2024-11-24
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Osteoarthritis of knee. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: The test group is referred to a center equipped with a back support device (health and wellness clinic) to receive the intervention. In addition to routine treatmen

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years. have been diagnosed with T2DM along with Grade 1,2 and 3 KOA as confirmed by the treating physician Willingness to use the knee and back recovery device in conjunction with other prescribed treatments. No other diseases or abnormalities in the knee or related joints No clinically diagnosed pathological sleep disorder

Exclusion criteria

Exclusion criteria: progression of the disease to Grade 4 KOA The occurrence of any potential adverse effects related to the use of the recovery device unwillingness to continue participation in the study

Design outcomes

Primary

MeasureTime frame
Sleep quality based on the Pittsburgh questionnaire. Timepoint: At the beginning of the intervention and three months after the intervention. Method of measurement: The Pittsburgh Sleep Quality Index.

Secondary

MeasureTime frame
Random blood sugar measured. Timepoint: Blood Glucose Levels: Random blood glucose levels will be measured for each patient using a glucometer at 10 intervals throughout the study. These measurements will be recorded in the researcher’s checklist. Method of measurement: According to the blood sugar measurement checklist and with a glucometer.;HbA1c: HbA1c levels will be monitored to assess long-term blood glucose control. Timepoint: At the beginning of the intervention and three months after the intervention. Method of measurement: Laboratory blood sample.;Body Mass Index (BMI): BMI will be calculated for each participant to evaluate their body weight relative to their height. Timepoint: At the beginning of the intervention and three months after the intervention. Method of measurement: Using a calibrated scale and measuring tape.;The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): The WOMAC is used to evaluate the therapeutic effects of total knee arthroplasty. Timepoint: At the beginning of the intervention and three months after the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC): WOMAC was developed and recommended for the evaluation of the treatment effect of Total Knee Arthroplasty [37, 38]. The WOMAC Index includes three subscales: pain (7 items), stiffness (2 items), and physical function (17 items). The Likert scale version of the index will be used with the following description for all items: none, mild, moderate, severe, or extreme, corresponding to an ordinal scale of 0–4. The score in each subscale is standardized to a score of 0 to 100, with higher scores indicating more pain, stiffness, and functional limitations.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPegah Matouripour

Tehran University of Medical Sciences

matourypour@yahoo.com+98 21 6692 7171

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Apr 3, 2026