The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

• Sponsor: Mostafa Hassanein, Msc (Other)
• Overall Status: Completed
• CT.gov ID: NCT05827484
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Actual Duration (Months): 14.1

Study Details

Study Description

Brief Summary

The aim of this comparative study is to determine whether or not LOSARTAN with its anti-fibrotic action has an added effect when administrated with platelet rich plasma injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries in comparison with the sole administration of platelet rich plasma.

Condition or Disease	Intervention/Treatment	Phase
PRP; Losartan; Muscle Injury; Sport Injury	Biological: Autologous platelets rich plasma; Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A New Treatment Modality For Skeletal Muscles Sports Injuries; Losartan Combination With PRP
• Actual Study Start Date: Oct 10, 2016
• Actual Primary Completion Date: Sep 5, 2017
• Actual Study Completion Date: Dec 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 patients with acute skeletal muscle injury underwent PRP injection Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in the site of injury in day 1 or 2 of the injury.	Biological: Autologous platelets rich plasma; 30 ml of venous blood were drawn from the participant by means of venipuncture. The collected blood was mixed with 3 ml anti-coagulant acid citrate dextrose in the centrifugation sterile tube. The blood sample was then centrifuged using the centrifugation machine. 3 ml of PRP from the buffy coat layer were loaded in a 5 ml syringe. After local sterilization and draping of the site of injection and under US guidance the hematoma was aspirated from the injury site and the freshly prepared PRP was injected.; Other Names: PRP
Experimental: 10 patients with acute skeletal muscle injury underwent PRP injection and oral LOSARTAN Patients with acute skeletal muscle injury received a single ultrasound guided local PRP injection in day 1 or 2 of injury in addition to administration of oral (50mg LOSARTAN /day) from day 5 to day 30.	Combination Product: Autologous platelets rich plasma + oral LOSARTAN administration; in addition to local PRP injection, 50 mg / day of LOSARTAN (Cozaar® 50 mg film-coated tablets) were administrated to the study group orally every morning from day 5 and till day 30 after injury.; Other Names: PRP + LOSARTAN

Outcome Measures

Primary Outcome Measures

1. ecchymosis [1or 2 days after injury]

   locally at the site of injury "present or absent"

2. ecchymosis [2 weeks after injury.]

   locally at the site of injury "present or absent"

3. ecchymosis [1month after injury.]

   locally at the site of injury "present or absent"

4. ecchymosis [3 months after injury.]

   locally at the site of injury "present or absent"

5. deformity [1 or 2 days after injury]

   palpable defects at the site of injury "present or absent"

6. deformity [2 weeks after injury.]

   palpable defects at the site of injury "present or absent"

7. deformity [1month after injury.]

   palpable defects at the site of injury "present or absent"

8. deformity [3 months after injury.]

   palpable defects at the site of injury "present or absent"

9. tenderness [1 or 2 days after injury]

   at the site of injury "present or absent"

10. tenderness [2 weeks after injury.]

    at the site of injury "present or absent"

11. tenderness [1month after injury.]

    at the site of injury "present or absent"

12. tenderness [3 months after injury.]

    at the site of injury "present or absent"

13. Pain at site of injury [1 or 2 days after injury]

    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain

14. Pain at site of injury [2 weeks after injury.]

    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain

15. Pain at site of injury [1month after injury.]

    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain

16. Pain at site of injury [3 months after injury.]

    pain at site of injury using visual analog score "VAS" where 0 is lowest and 100 is highest pain

17. spasm [1or 2 days after injury.]

    spasm in the injured muscle "present or absent"

18. spasm [2 weeks after injury.]

    spasm in the injured muscle "present or absent"

19. spasm [1month after injury.]

    spasm in the injured muscle "present or absent"

20. spasm [3 months after injury.]

    spasm in the injured muscle "present or absent"

21. Pain with active muscle stretches [1or 2 days after injury.]

    "present or absent"

22. Pain with active muscle stretches [2 weeks after injury.]

    "present or absent"

23. Pain with active muscle stretches [1month after injury.]

    "present or absent"

24. Pain with active muscle stretches [3 months after injury.]

    "present or absent"

25. Pain with passive muscle stretches [1 or 2 days after injury.]

    "present or absent"

26. Pain with passive muscle stretches [2 weeks after injury.]

    "present or absent"

27. pain with passive muscle stretches [3 months after injury.]

    "present or absent"

28. Pain with passive muscle stretches [1month after injury.]

    "present or absent"

29. pain with active muscle contraction [1 or 2 days after injury.]

    "present or absent"

30. pain with active muscle contraction [2 weeks after injury.]

    "present or absent"

31. pain with active muscle contraction [1month after injury.]

    "present or absent"

32. pain with active muscle contraction [3 months after injury.]

    "present or absent"

33. pain with against resistance muscle contraction [1 or 2 days after injury.]

    "present or absent"

34. pain with against resistance muscle contraction [2 weeks after injury.]

    "present or absent"

35. pain with against resistance muscle contraction [1month after injury.]

    "present or absent"

36. pain with against resistance muscle contraction [3 months after injury.]

    "present or absent"

37. size of injury [1 or 2 days after injury.]

    in cm2 using ultrasound

38. size of injury [2 weeks after injury.]

    in cm2 using ultrasound

39. size of injury [1month after injury.]

    in cm2 using ultrasound

40. size of injury [3 months after injury.]

    in cm2 using ultrasound

41. disorganized fibrous tissue [1 or 2 days after injury.]

    "present or absent" using ultrasound

42. disorganized fibrous tissue [2 weeks after injury.]

    "present or absent" using ultrasound

43. disorganized fibrous tissue [1month after injury.]

    "present or absent" using ultrasound

44. disorganized fibrous tissue [3 months after injury.]

    "present or absent" using ultrasound

45. hematoma [1 or 2 days after injury.]

    "present or absent" using ultrasound

46. hematoma [2 weeks after injury.]

    "present or absent" using ultrasound

47. hematoma [1month after injury.]

    "present or absent" using ultrasound

48. hematoma [3 months after injury.]

    "present or absent" using ultrasound

49. Doppler signal [1 or 2 days after injury.]

    "present or absent" using ultrasound

50. Doppler signal [2 weeks after injury.]

    "present or absent" using ultrasound

51. Doppler signal [1month after injury.]

    "present or absent" using ultrasound

52. Doppler signal [3 months after injury.]

    "present or absent" using ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult age. (18 - 40 year old).

• Clinically diagnosed acute skeletal muscle injury with maximum 3 days duration and ultrasonographically confirmed grade II according to Woodhouse et al.

• Understanding the study and accepting the participation

Exclusion Criteria:

• Any connective tissue disease (e.g. rheumatoid arthritis, systemic lupus erythematous, etc.)

• Hypertension or hypotension

• Diabetes mellitus

• Any cardiac or pulmonary disease

• NSAIDs use in less than a week prior to the beginning of the study.

• Muscle injuries requiring surgical interference.

• No detectable injury ultrasonographically.

• Anemia

• Thrombocytopenia or any platelet disorder.

• Pregnancy or lactation.

• Local infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mostafa Hassanein, Msc

Investigators

• Principal Investigator: Mostafa M. Hassanein, Msc, Ain Shams University hospitals
• Study Director: Wael A.M. Nassar, MD, Ain Shams University hospitals
• Principal Investigator: Medhat M. Magdy, Msc, Ain Shams University hospitals
• Principal Investigator: Amr G. Gendya, MD, Ain Shams University hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

• Woodhouse JB, McNally EG. Ultrasound of skeletal muscle injury: an update. Semin Ultrasound CT MR. 2011 Apr;32(2):91-100. doi: 10.1053/j.sult.2010.12.002.

• Responsible Party: Mostafa Hassanein, Msc, principal investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05827484
• Other Study ID Numbers: FMASU MS 22/2016
• First Posted: Apr 25, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Wounds and Injuries; Athletic Injuries; Losartan

Study Results

No Results Posted as of Apr 25, 2023