Effect of treatment program on pain, function and disability in type 2 Diabetic individuals with long term low back pain
- Conditions
- Type 2 diabetes mellitus with other specified complications,
- Registration Number
- CTRI/2023/03/050346
- Lead Sponsor
- Spry Therapeutics Private Limited
- Brief Summary
This study is a randomized controlled trial. Aim of this study is to evaluate the effect of Comprehensive exercise based rehabilitation program on Pain, Function, and Disability in Type 2 Diabetes Mellitus Individuals with Chronic Low Back Pain. Objectives of this study are Phase 1: To profile characteristics of low back pain in Individuals with Type 2 Diabetes Mellitus; Phase 2: To evaluate the effect of comprehensive rehabilitation in Type 2 Diabetes Mellitus individuals suffering from chronic low back pain. There will be 2 groups, intervention group and control group. Intervention group will receive comprehensive exercise based rehabilitation program and control group will receive standard protocol. 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 exercises, functional strength restoration, flexibility training, lumbar stabilization exercises, neural mobilization, and functional exercises along with standard care. Exercises will be done for 12 weeks. These exercises will be progressed as per speed, resistance, repetition, and difficulty at 4th and 8th week. Control group will receive standard care, moist heat for pain relief and conventional exercises which will include core and low back exercises. Primary outcome measures are Pressure pain Threshold using algometer, Gait analysis using Win-track and Pain using Numeric pain rating scale. Secondary outcome measures are Disability using Oswestry disability index and Soft tissue changes using MRI of low back. Outcomes will be measured at baseline, at 12 weeks and at 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 124
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%.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Pressure pain Threshold using algometer Before start of the intervention, at 12 weeks and at 24 weeks after that • Gait analysis using Win-track Before start of the intervention, at 12 weeks and at 24 weeks after that • Pain using Numeric pain rating scale Before start of the intervention, at 12 weeks and at 24 weeks after that
- Secondary Outcome Measures
Name Time Method • Disability using Oswestry disability index • Soft tissue changes using MRI of low back
Trial Locations
- Locations (1)
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaShetty Shrija JayaPrincipal investigator08202923054shettyshrija@gmail.com