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Clinical trial on back pain patients

A Prospective, open-label, clinical study to evaluate the efficacy of Sacral Belt in treating mild back pain in male & female volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053694
Enrollment
15
Registered
2023-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: M545- Low back pain

Interventions

Intervention1: Sacral Belt: Sacral Belt Frequency: The belt can be worn daily minimum 2 hrs Total Duration: 30days Control Intervention1: Nil: Nil

Sponsors

UNITED MEDICARE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years 2. Gender: both male and female subjects 3. Mentally Sound 4. Subjects willing to give a voluntary written informed consent, and agree to come for regular follow up. 5. Subjects with mild back pain. 6. Subjects willing to abide by and comply with the study protocol. 7. Subjects with Lumbar Spondylitis, Spondylolisthesis, Lumbago, Postural Fatigue or Sciatica Pain are included. 8. Individuals willing to use study products for the study duration

Exclusion criteria

Exclusion criteria: 1. Individuals who will not give written consent (wet-ink/electronic) 2. Pregnancy or breast feeding. 3. Subject having chronic illness or had major surgery in the last year. 4. Presence of other neurological disorders (e.g., multiple sclerosis, Parkinson’s Disease) 5. Subjects with pre-existing severe systemic disease necessitating long-term medication. 6. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ. 7. Participation in the current or previous clinical trial with any approved or 8. investigational products during the past 1 month.

Design outcomes

Primary

MeasureTime frame
Percentage improvement in back pain from baseline visit to last visit was evaluated by physical assessment, lumbar assessment score & Visual Analogue ScoreTimepoint: Day 0 to Day 30

Secondary

MeasureTime frame
Consumer acceptance for ideal back support was assessed by customer feedback questionnairesTimepoint: Day 0 to Day 30

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt. Ltd

surya.ashok@gmail.com9880999297

Outcome results

None listed

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