CTRI/2023/03/050346
Not yet recruiting
未知
Effect of comprehensive rehabilitation program on pain, function and disability in Type 2 Diabetes Mellitus individuals with chronic low back pain
Spry Therapeutics Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Spry Therapeutics Private Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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