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

Not Applicable

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

• Registration Number: CTRI/2023/03/050346
• Lead Sponsor: Spry Therapeutics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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
â?¢ Pressure pain Threshold using algometer <br/ ><br>â?¢ Gait analysis using Win-track <br/ ><br>â?¢ Pain using Numeric pain rating scaleTimepoint: Before start of the intervention, at 12 weeks and at 24 weeks after that

Secondary Outcome Measures

Name	Time	Method
â?¢ Disability using Oswestry disability index <br/ ><br>â?¢ Soft tissue changes using MRI of low backTimepoint: Before start of the intervention, at 12 weeks and at 24 weeks after that