A double blind, double dummy, multicenter, randomized, placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients affected by chronic low back pain

Conditions

Low Back Pain

Brief summary

Mean change from baseline to Day 15 in NRS-11

Detailed description

LBP related disability improvement measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a, at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15., Clinical improvement evaluated at baseline visit and then at V3-Day 7 and V4-Day 15 through the following parameters: Range of Motion testing, Joint reflex changes (ROT), Lasegue’s test (passive straight leg raise), Femoral stretch test (Wasserman test), Dandy’s sign, Valleix’s points pressure, PGA and CGI of the status of LBP evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15, Daily rescue medication required for pain relief, Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo 2 - plaster

DRUGACETAMOL adulti 500 mg compresse

DRUGPlacebo 1 - injectable solution

DRUGITAMI 140 mg cerotto medicato

DRUGTRICORTIN 1000 “12 mg+1 mg/2 ml soluzione iniettabile per uso intramuscolare”

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change from baseline to Day 15 in NRS-11	—

Secondary

Measure	Time frame
LBP related disability improvement measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a, at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15., Clinical improvement evaluated at baseline visit and then at V3-Day 7 and V4-Day 15 through the following parameters: Range of Motion testing, Joint reflex changes (ROT), Lasegue’s test (passive straight leg raise), Femoral stretch test (Wasserman test), Dandy’s sign, Valleix’s points pressure, PGA and CGI of the status of LBP evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15, Daily rescue medication required for pain relief, Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit.	—

Measure

Time frame

LBP related disability improvement measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a, at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15., Clinical improvement evaluated at baseline visit and then at V3-Day 7 and V4-Day 15 through the following parameters: Range of Motion testing, Joint reflex changes (ROT), Lasegue’s test (passive straight leg raise), Femoral stretch test (Wasserman test), Dandy’s sign, Valleix’s points pressure, PGA and CGI of the status of LBP evaluated at baseline visit and then in the following visits: V3-Day 7 and V4-Day 15, Daily rescue medication required for pain relief, Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit.

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Countries

Italy

Outcome results

None listed