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Trial record 21 of 52 for:    "Frozen Shoulder"

Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder

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ClinicalTrials.gov Identifier: NCT03951896
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Funda Atamaz Calis, Ege University

Brief Summary:

This study was done to investigate whether platelet rich plasma(PRP) injections are effective in the management of adhesive capsulitis of the shoulder(AC).Patients were randomized to 2 groups, and one group took PRP injections for 3 times every two weeks, while the other group took saline injections in same frequency and volume. A standardized exercise programme was also applied to all patients.

Patients were then evaluated with Shoulder Pain and Disability Index(SPADI), Visual analogous scales for pain and disability, Ranges of Movements and use of analgesics in before, after and 3rd month of the therapy.


Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of Shoulder Adhesive Capsulitis Frozen Shoulder Biological: PRP Other: Saline injection Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The injection process was made with injectors coated with opaque adhesive tapes, and were prepared by another researcher who wasn't involved in injection or assessment. The statistical analyses were conducted without knowing the content of the groups.
Primary Purpose: Treatment
Official Title: Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder
Actual Study Start Date : May 3, 2014
Actual Primary Completion Date : September 4, 2015
Actual Study Completion Date : September 4, 2015

Arm Intervention/treatment
Experimental: PRP

Interventions:

A venous blood sample of 8.5 ml were obtained from all patients. For the treatment group, the blood samples were treated with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. The blood was then centrifugated for 5 minutes with RCF 1200 G velocity to clump red blood cells, and then centrifugated for 10 minutes in same velocity to obtain platelet concentrate. 2 ml's of the resulting platelet rich plasma was injected to the shoulder of the subjects.

Biological: PRP
A venous blood sample of 8.5 ml were obtained from all patients. For the treatment group, the blood samples were treated with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. The blood was then centrifugated for 5 minutes with RCF 1200 G velocity to clump red blood cells, and then centrifugated for 10 minutes in same velocity to obtain platelet concentrate. 2 ml's of the resulting platelet rich plasma was injected to the shoulder of the subjects.All of the injections were done every two weeks, for a total of 3 times using 21 G injection needles with injection technique of posterior approach.
Other Name: Platelet Rich Plasma

Placebo Comparator: Placebo
For the control group, same amount of blood was sampled and they were given a same amount of waiting time with the other group, with the resulting injection preparate being 2 ml's of 0,9% saline instead.
Other: Saline injection
2 ml's of NaCl solution with 0,9% concentration was applied to the shoulders of the participants.




Primary Outcome Measures :
  1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: 3 months ]
    Shoulder Pain and Disability Index (SPADI) is a tool to assess pain and disability in patients with shoulder pain, which was extensively used in studies involving AC of the shoulder6, 15, 16. It consists of 5 questions in pain domain, and 8 questions in disability domain, which were expressed in a visual analogous scale.

  2. Visual Analogous Scales for pain [ Time Frame: 3 months ]
    Patients were asked to describe their pain, level of disability or treatment satisfaction on a 10 cm long line, with 0 point being "none", and 10 cm point being "highest possible". The proximity of the marked point to the 0 end was measured, and the results were recorded


Secondary Outcome Measures :
  1. Visual Analogous Scales for disability [ Time Frame: 3 months ]
    Patients were asked to describe their pain, level of disability or treatment satisfaction on a 10 cm long line, with 0 point being "none", and 10 cm point being "highest possible". The proximity of the marked point to the 0 end was measured, and the results were recorded

  2. Shoulder ranges of motions [ Time Frame: 3 months ]
    Shoulder range of motions were also evaluated at the time points that were mentioned, as secondary outcome measures. All of the measurements were done accordingly to the guidelines of American College of Orthopedic Surgeons by a conventional goniometer18, 19. The researcher who obtained the measurements was an experienced therapist in this field, and was blind to the treatment groups.

  3. Analgesic use [ Time Frame: 3 months ]
    Subjects were also asked about their needs of analgesic usage, namely acetaminophen. They were asked to write down each time they took an acetaminophen tablet of 500 mgs. The results were recorded as miligrams.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being over 18 years old and having a shoulder pain with restriction for 3 months at least, and 9 months at most(Pain VAS being >40 mm, and loss of ROM for affected side more than %25 of unaffected side).

Exclusion Criteria:

  • Subjects were excluded if they had uncontrolled diabetes, active inflammatory diseases, ongoing pregnancy, severe anemia, psychiatric diseases that may affect compliance or cancer. Patients who had a history of trauma, recent injection therapies(<3 months), surgery or allergy to local anaesthetics, or signs of complex regional pain syndrome, local infections or use of non steroidal anti-inflammatory drugs throughout the study were also excluded.

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Responsible Party: Funda Atamaz Calis, Professor in Ege University School of Medicine, Ege University
ClinicalTrials.gov Identifier: NCT03951896     History of Changes
Other Study ID Numbers: PRP-AC
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Sodium Citrate
Anticoagulants