diclofenac and Injuries, Soft Tissue studies

Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.

Research Excerpts

Excerpt	Relevance	Reference
"The aim of this study was to compare the anti-edema effects of a stable prostacyclin analogue, iloprost, with parenteral and local forms of a non-steroidal anti-inflammatory drug, diclofenac sodium, on traumatic soft tissue edema."	7.76	Comparison of anti-edema effects of iloprost and diclofenac sodium on traumatic rat paw edema. ( Doğan, A; Kalender, AM; Kılınçoğlu, V; Sebik, A; Toker, S; Uslu, M, 2010)
" No serious adverse events (SAEs) were registered, and the most commonly detected adverse events were skin reactions at the application site."	7.30	Efficacy and safety of Diclofenac sodium plaster in patients with acute pain of the limbs: a randomized, placebo and active-controlled, double-blind, parallel-group trial. ( Barbaro, B; Giordan, N; Gruber, G; Pabst, H; Picciotto, R, 2023)
"Many types of acute pain have been managed with traditional oral non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors (coxibs)."	6.46	Topical diclofenac epolamine patch 1.3% for treatment of acute pain caused by soft tissue injury. ( Argoff, CE; McCarberg, BH, 2010)
"A topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions; however, its safety and efficacy have not been investigated in a pediatric population."	5.51	Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. ( Frangione, V; Hoehler, FK; Jones, C; Jones, CA; Ledesma, G; Wisman, PP, 2022)
"To compare the ketoprofen TDS patch with diclofenac gel in the treatment of traumatic acute pain in benign sport-related soft-tissue injuries."	5.12	Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries. ( Cobián, C; Esparza, F; García-Cota, JJ; Jiménez, JF; Maestro, A; Sánchez, C, 2007)
"The diclofenac patch was well tolerated."	3.80	[Topical treatment of blunt-impact soft tissue injuries]. ( Frentzel, A; Gallacchi, G; Heidecker, JL, 2003)
"The aim of this study was to compare the anti-edema effects of a stable prostacyclin analogue, iloprost, with parenteral and local forms of a non-steroidal anti-inflammatory drug, diclofenac sodium, on traumatic soft tissue edema."	3.76	Comparison of anti-edema effects of iloprost and diclofenac sodium on traumatic rat paw edema. ( Doğan, A; Kalender, AM; Kılınçoğlu, V; Sebik, A; Toker, S; Uslu, M, 2010)
" No serious adverse events (SAEs) were registered, and the most commonly detected adverse events were skin reactions at the application site."	3.30	Efficacy and safety of Diclofenac sodium plaster in patients with acute pain of the limbs: a randomized, placebo and active-controlled, double-blind, parallel-group trial. ( Barbaro, B; Giordan, N; Gruber, G; Pabst, H; Picciotto, R, 2023)
" The most common adverse events were treatment site related (n=16, 7."	2.76	Analgesic efficacy and safety of the diclofenac epolamine topical patch 1.3% (DETP) in minor soft tissue injury. ( Carr, W; Kuehl, K; Magelli, M; Rovati, S; Yanchick, J, 2011)
" Local adverse events were minimum for both groups."	2.67	Single blind study to evaluate the efficacy and safety of naproxen gel compared with diclophenac emulgel in the treatment of soft tissue injuries. ( Butrón, F; Galicia, A; Martinez-Zurita, F; Zamora, G, 1994)
"Many types of acute pain have been managed with traditional oral non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors (coxibs)."	2.46	Topical diclofenac epolamine patch 1.3% for treatment of acute pain caused by soft tissue injury. ( Argoff, CE; McCarberg, BH, 2010)
"Diclofenac is a commonly used non-steroidal anti-inflammatory drug (NSAID) for symptom control in osteoarthritis (OA) of the knee and soft tissue injuries."	2.44	Topical diclofenac: clinical effectiveness and current uses in osteoarthritis of the knee and soft tissue injuries. ( Banning, M, 2008)
"Diclofenac was the NSAID of choice for 69."	1.30	Analgesia in soft-tissue injury: current practice in Auckland is not supported by the available evidence. ( Jones, PG, 1999)

Research

Studies (13)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Dermatologic Assessment at the Patch Application Site

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (15.38)	18.2507
2000's	3 (23.08)	29.6817
2010's	6 (46.15)	24.3611
2020's	2 (15.38)	2.80

Authors	Studies
Jones, CA	1
Hoehler, FK	1
Frangione, V	2
Ledesma, G	1
Wisman, PP	1
Jones, C	1
Pabst, H	1
Gruber, G	1
Picciotto, R	1
Barbaro, B	1
Giordan, N	1
Li, C	1
Rovati, S	3
Zheng, Q	1
Banning, M	1
Yanchick, J	2
Magelli, M	2
Bodie, J	1
Sjogren, J	1
Kuehl, KS	1
McCarberg, BH	1
Argoff, CE	1
Uslu, M	1
Kılınçoğlu, V	1
Toker, S	1
Kalender, AM	1
Doğan, A	1
Sebik, A	1
Kuehl, K	1
Carr, W	1
Gallacchi, G	1
Frentzel, A	1
Heidecker, JL	1
Esparza, F	1
Cobián, C	1
Jiménez, JF	1
García-Cota, JJ	1
Sánchez, C	1
Maestro, A	1
Butrón, F	1
Galicia, A	1
Zamora, G	1
Martinez-Zurita, F	1
Jones, PG	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries[NCT02132247]	Phase 4	104 participants (Actual)	Interventional	2014-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6. (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution

Investigator Assessment of the Global Response to Therapy on a 5-point Scale

Intervention	Units on a scale (Mean)
	Day1-2	Day 3-4	Day 5-7	Day 8-11	Day 12-15
Flector Patch/Age 12-16	0.04	0.06	0.00	0.06	0.00
Flector Patch/Age 6-11	0.10	0.04	0.11	0.00	0.00

5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5. (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution

Patient Assessment of Pain on a 6-point Scale

Intervention	Participants (Count of Participants)
	No clinical improvement	Slight clinical improvement	Moderate clinical improvement	Marked clinical improvement	Normal function with no pain
Flector Patch/Age 12-16	1	0	2	9	40
Flector Patch/Age 6-11	1	0	2	2	47

"Wong-Baker FACES Scale 6-point scale:~No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5." (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution

Plasma Concentration of Diclofenac

Intervention	units on a scale (Mean)
	Baseline	Final Visit
Flector Patch/Age 12-16	3.58	0.27
Flector Patch/Age 6-11	3.37	0.12

(NCT02132247)
Timeframe: Day 2 and either Day 4, 7 or 14, depending upon pain resolution

Intervention	ng/mL (Mean)
	24-hour	Final Visit
Flector Patch/Age 12-16	1.46	1.11
Flector Patch/Age 6-11	1.83	2.49

Article	Year
Topical diclofenac: clinical effectiveness and current uses in osteoarthritis of the knee and soft tissue injuries. Expert opinion on pharmacotherapy, 2008, Volume: 9, Issue:16 Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Tolerance; Humans; Osteoarthritis	2008
Review of the efficacy and tolerability of the diclofenac epolamine topical patch 1.3% in patients with acute pain due to soft tissue injuries. Clinical therapeutics, 2010, Volume: 32, Issue:6 Topics: Acute Disease; Administration, Cutaneous; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials a	2010
Topical diclofenac epolamine patch 1.3% for treatment of acute pain caused by soft tissue injury. International journal of clinical practice, 2010, Volume: 64, Issue:11 Topics: Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Contusions; Diclofenac; Humans; Pain; Soft Tiss	2010
[Topical treatment of blunt-impact soft tissue injuries]. Praxis, 2003, Dec-17, Volume: 92, Issue:51-52 Topics: Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Athletic Injuries; Cyclooxygenase	2003

Article	Year
Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. Clinical drug investigation, 2022, Volume: 42, Issue:1 Topics: Acute Pain; Administration, Topical; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Child; Dic	2022
Efficacy and safety of Diclofenac sodium plaster in patients with acute pain of the limbs: a randomized, placebo and active-controlled, double-blind, parallel-group trial. European review for medical and pharmacological sciences, 2023, Volume: 27, Issue:7 Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Soft T	2023
Diclofenac epolamine medicated plaster in the treatment of minor soft tissue injuries: a multicenter randomized controlled trial. Current medical research and opinion, 2013, Volume: 29, Issue:9 Topics: Administration, Topical; Adolescent; Adult; Aged; Analgesics; Anti-Inflammatory Agents, Non-Steroida	2013
Analgesic efficacy and safety of the diclofenac epolamine topical patch 1.3% (DETP) in minor soft tissue injury. International journal of sports medicine, 2011, Volume: 32, Issue:8 Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non	2011
[Topical treatment of blunt-impact soft tissue injuries]. Praxis, 2003, Dec-17, Volume: 92, Issue:51-52 Topics: Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Athletic Injuries; Cyclooxygenase	2003
Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries. British journal of sports medicine, 2007, Volume: 41, Issue:3 Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Athletic Injuri	2007
Single blind study to evaluate the efficacy and safety of naproxen gel compared with diclophenac emulgel in the treatment of soft tissue injuries. Proceedings of the Western Pharmacology Society, 1994, Volume: 37 Topics: Adult; Contusions; Diclofenac; Edema; Female; Gels; Humans; Male; Middle Aged; Naproxen; Pain Measur	1994

Article	Year
Time to significant pain reduction following DETP application vs placebo for acute soft tissue injuries. Current medical research and opinion, 2010, Volume: 26, Issue:8 Topics: Acute Disease; Administration, Topical; Adolescent; Adult; Aged; Ankle Joint; Anti-Inflammatory Agen	2010
Comparison of anti-edema effects of iloprost and diclofenac sodium on traumatic rat paw edema. Acta orthopaedica et traumatologica turcica, 2010, Volume: 44, Issue:6 Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Edema; Gels; Iloprost; Infusions, Pare	2010
Analgesia in soft-tissue injury: current practice in Auckland is not supported by the available evidence. The New Zealand medical journal, 1999, Oct-08, Volume: 112, Issue:1097 Topics: Acetaminophen; Adult; Analgesia; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal;	1999

diclofenac and Injuries, Soft Tissue