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Role of Adjuvant AYUSH and TENS therapy among Spinal Injury patients

A Pragmatic Clinical Trial (PrCT) to study the efficacy of adjuvant Neuromodulation Vs AYUSH therapy in surgically operated patients of traumatic thoracolumbar injury - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086806
Enrollment
80
Registered
2025-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: M961- Postlaminectomy syndrome, not elsewhere classified

Interventions

None listed

Sponsors

AIIMS Raebareli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Our study comprises of two intervention arms and one historical data arm as follows (a) Group A: Surgically operated patients with Adjunct Neuromodulation: TENS therapy will be used on Day-1 post-operative (T0) at least once per day for twice (morning and evening) 45-minute treatment session. TrEMG will be used once in the intra-operative period only. (b) Group B: Surgically operated patients with AYUSH Therapy: The patients in this group will be under supervision of AYUSH doctors after surgery. Patients will receive AYUSH ministry certified oral medicines and targeted therapies. Following post operative protocol will be used as adjunct

Exclusion criteria

Exclusion criteria: Randomisation will be done by Nursing Officer of ward at the time of taking consent (one-day prior to surgery). We will be using computer generated random numbers (Well Equi-distributed Long-period Linear; based on linear recurrences modulo 2 over a finite binary field F2) for simple randomisation (https://leventozturk.com/engineering/random/). Nursing Officer will just write Group name (â??Aâ?? or â??Bâ??) over the file and further adjunct protocol will be followed as per methodology. The data collection will be done by blinded third researcher (SM) and data analysis will be done by blinded fourth researcher (SM, BN). The independent third and fourth researchers are not directly involved in surgical procedure.

Design outcomes

Primary

MeasureTime frame
1. Evaluate the clinical advantage of adjunct Triggered Electromyography (TrEMG) and TENS therapy in the operated patients of thoracolumbar spine injury. 2. Evaluate the clinical advantage of adjunct Ayurveda medicine plus Abhyangam therapy in the operated patients of thoracolumbar spine injury 3. Compare the neurological outcome and Quality of life (QoL) among two treatment options. Timepoint: Time lineDetails T0One day before surgery T1Post operative day-1 T2Post operative day -7 T3At 6th week of surgery T4At 3-months of surgery

Secondary

MeasureTime frame
To study the surgical outcome of thoracic lumbar spine surgery operated in our institute.Timepoint: Time line Details T0 One day before surgery T1 Post operative day-1 T2 Post operative day -7 T3 At 6th week of surgery T4 At 3-months of surgery

Countries

India

Contacts

Public ContactSuyash Singh

AIIMS Raebareli

shreyajit23@gmail.com6393627740

Outcome results

None listed

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