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Effect of treatment program on pain, function and disability in type 2 Diabetic individuals with long term low back pain

Effect of comprehensive rehabilitation program on pain, function and disability in Type 2 Diabetes Mellitus individuals with chronic low back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050346
Enrollment
124
Registered
2023-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Comprehensive exercise based rehabilitation program: Comprehensive exercise based rehabilitation program will include pain management using photobiomodulation therapy
pain education and ergonomic advice
and exercise interventions targeting functional restoration and recovery which will include low back exercises, core exercises, lower limb exercises, and ambulation which will include postural exercis

Sponsors

Spry Therapeutics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Phase I: Age 18 to 65 years, participants diagnosed with T2DM and on medication from past 1 year, T2DM with or without peripheral neuropathy, HbA1c > 6.4% Phase II: Age 18 to 65 years, history of low back pain LBP > 3 months, Participants diagnosed with Type 2 Diabetes Mellitus and on medication from past 1 year, HbA1c > 6.4%, Numeric pain rating scale >3, Oswestry disability index Score >20%.

Exclusion criteria

Exclusion criteria: Phase I: Infections or tumors of the spine, systemic bone or joint disorders, neuromuscular pathology, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, acute disc prolapse, prolapsed Intervertebral disc of other causes, low back pain due to traumatic causes Phase II: Infections or tumors of the spine, systemic bone or joint disorders, unstable cardiovascular and pulmonary diseases, polyneuropathies and musculoskeletal system diseases, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, any systemic complications which prevents their participation in study

Design outcomes

Primary

MeasureTime frame
• Pressure pain Threshold using algometer • Gait analysis using Win-track • Pain using Numeric pain rating scaleTimepoint: Before start of the intervention, at 12 weeks and at 24 weeks after that—

Secondary

MeasureTime frame
• Disability using Oswestry disability index • Soft tissue changes using MRI of low backTimepoint: Before start of the intervention, at 12 weeks and at 24 weeks after that—

Countries

India

Contacts

Public ContactDr G Arun Maiya

Manipal Academy of Higher Education

shettyshrija@gmail.com8861871688

Outcome results

None listed

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