| Study period | ||||||
---|---|---|---|---|---|---|---|
Screening | Baseline | Treatment phase | Follow-up phase | ||||
Timepoint | -1 week | 0 | 1-day | 7-day | 14-day | 30-day | 90-day |
Enrolment | |||||||
 Eligibility screen | × |  |  |  |  |  |  |
 Informed consent | × |  |  |  |  |  |  |
 Medical history | × |  |  |  |  |  |  |
 Physical examination | × |  |  |  |  |  |  |
 Comorbidity |  |  |  |  |  |  |  |
 Allocation |  | × |  |  |  |  |  |
Interventions | |||||||
 LP5 group |  |  | × | × | × |  |  |
 Placebo group |  |  | × | × | × |  |  |
Outcomes | |||||||
 ASES |  | × |  |  |  | × | × |
 OSS |  | × |  |  |  | × | × |
 CMS |  | × |  |  |  | × | × |
 ROM |  | × |  |  |  | × | × |
 SF-36 |  | × |  |  |  | × | × |
 PSQI |  | × | × | × | × | × | × |
 VAS |  | × | × | × | × | × | × |
 PPT |  | × | × | × | × | × | × |
Safety assessments | |||||||
 BRE |  | × |  |  |  |  | × |
 URT |  | × |  |  |  |  | × |
 LFTs |  | × |  |  |  |  | × |
 ESR |  | × |  |  |  |  | × |
 ASO |  | × |  |  |  |  | × |
 RF |  | × |  |  |  |  | × |
 Opioid consumption |  | × | × | × | × | × | × |
 Adverse events |  | × | × | × | × | × | × |