Mechanical Low Back Pain Clinical Trial
Official title:
National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.
The purpose of this study is to determine whether the fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute episode of mechanical postural low back pain than Voltaren®. Will be randomized 110 participants of both sexes, aged 18 years or older and less than 65 years of age with an acute episode of mechanical postural low back pain and they will be allocated to one of two treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium; or Group 2: Voltaren®
The fixed combination of orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac
sodium 50mg aims to provide patients with anti-inflammatory, analgesic and myorelaxant action
with adequate safety and tolerability profile.
Diclofenac is a nonsteroidal anti-inflammatory with analgesic, anti-inflammatory and
antipyretic action and is effective in the treatment of a variety of acute and chronic
inflammatory and painful conditions. Its anti-inflammatory effect occurs by inhibiting the
synthesis of prostaglandins by inhibiting COX-1 and COX-2 in an equipotent manner.
Orphenadrine, on the other hand, is a central acting muscle relaxant that has analgesic and
anticholinergic effects. It presents clinical efficacy in the treatment of painful conditions
associated to pictures such as strains and sprains, especially of acute character, among
other musculoskeletal conditions that present with pain and muscular contracture.
Concerning acetaminophen, its a drug with analgesic and antipyretic action as well as
anti-inflammatory properties. It is widely used in a wide variety of pathologies with a focus
on the treatment of mild to moderate pain. It is a non-opioid analgesic with action in the
inhibition of cyclooxygenase and consequently in the production of prostaglandins, with
potency similar to that of aspirin. It is the analgesic of choice for children, the elderly
and pregnant women. It has been used successfully in the treatment of back pain. The
association between acetaminophen and orphenadrine is known and clinically effective in
analgesia, as well as the combination of acetaminophen and diclofenac, which also provides
clinical efficacy in the management of acute postoperative pain.
Lastly, caffeine, an alkaloid belonging to the group of methylxanthines, is an agonist that
competes with adenosine receptors, acting in these receptors in very varied areas, such as
throughout the peripheral circulation and in the cerebral cortex. Caffeine enhances the
effects of other analgesics, improves acetaminophen pharmacokinetics, and induces mood
changes. All these mechanisms may contribute to improve the analgesic action of
acetaminophen.
The association of non-steroidal anti-inflammatory, muscle relaxant, analgesic and caffeine
in the symptomatic treatment of painful conditions associated with the musculoskeletal system
is quite old.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06009263 -
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
|
N/A | |
| Completed |
NCT05052840 -
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain
|
N/A | |
| Completed |
NCT04562701 -
Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
|
||
| Not yet recruiting |
NCT04542798 -
CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting
|
N/A | |
| Terminated |
NCT02276794 -
Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain
|
N/A | |
| Recruiting |
NCT01940744 -
Prescriptive Mobilization Versus a Pragmatic Mobilization
|
N/A | |
| Completed |
NCT02226692 -
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain
|
N/A | |
| Recruiting |
NCT05616702 -
Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
|
N/A | |
| Recruiting |
NCT02622789 -
Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain
|
N/A | |
| Not yet recruiting |
NCT05088031 -
Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain
|
||
| Completed |
NCT03949179 -
Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model
|
||
| Completed |
NCT01591824 -
Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
|
N/A | |
| Completed |
NCT03517410 -
Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain
|
||
| Completed |
NCT02239289 -
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients
|
N/A | |
| Not yet recruiting |
NCT06330792 -
Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain
|
N/A | |
| Recruiting |
NCT05404997 -
Comparative Effects of SWT and Maitland LM in Mechanical LBP
|
N/A | |
| Completed |
NCT05475912 -
Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
|
N/A | |
| Not yet recruiting |
NCT04726579 -
CBD Oil in Mechanical Back Pain
|
||
| Recruiting |
NCT02491879 -
Ketoprofen Gel vs Placebo in Low Back Pain
|
Phase 4 | |
| Completed |
NCT01557049 -
Global Postural Reeducation in Chronic Low Back Pain
|
N/A |