A Pragmatic Clinical Trial (PrCT) to study the efficacy of adjuvant Neuromodulation Vs AYUSH therapy in surgically operated patients of traumatic thoracolumbar injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1. Evaluate the clinical advantage of adjunct Triggered Electromyography (TrEMG) and TENS therapy in the operated patients of thoracolumbar spine injury.
Study Overview
Brief Summary
This research project’s aim is to investigate the adjunct role of neuromodulation and AYUSH therapy and predictors of poor outcome in TSI. The study will use a pragmatic clinical design, involving patients having unstable spinal injury and is being operated for same, admitted to a level 1 center of excellence, where TSI is confirmed by CT scan and neurologically (as per AO system of classification). The study will compare the efficacy of post-operative adjunct TENS therapy with intra-operative TcEMG stimulation Vs Ayurveda oral medicine and therapy. The study will also assess the clinical outcomes of the patients using QoL Sci and Barthel rehabilitation scores. The study will analyse the correlation across various groups and the outcome measures, as well as the potential confounding factors, like age, along with gender, along with injury severity, surgical treatment, and medical administration. The study will contribute to the understanding of the pathophysiology and prognosis of electrophysiology, and potentially therapeutic targets for AYUSH therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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.
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 (‘A’ or ‘B’) 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.
Outcomes
Primary Outcomes
1. Evaluate the clinical advantage of adjunct Triggered Electromyography (TrEMG) and TENS therapy in the operated patients of thoracolumbar spine injury.
Time Frame: 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
2. Evaluate the clinical advantage of adjunct Ayurveda medicine plus Abhyangam therapy in the operated patients of thoracolumbar spine injury
Time Frame: 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
3. Compare the neurological outcome and Quality of life (QoL) among two treatment options.
Time Frame: 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
Secondary Outcomes
- To study the surgical outcome of thoracic lumbar spine surgery operated in our institute.(Time line Details)
Investigators
Suyash Singh
AIIMS Raebareli