The Efficacy of PRP Injection in the Treatment of Rotator Cuff Syndrome
Condition: Shoulder Pain; Musculoskeletal Diseases; Rotator Cuff Tendinopathy; Rotator Cuff Syndrome
MeSH terms: Shoulder Pain; Tendinopathy; Musculoskeletal Diseases; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of single PRP injection compared with
      placebo and multiple PRP injections on pain, quality of life, shoulder function and muscle
      strength in the treatment of patients who have tendinopathy and/or partial tear in the
      rotator cuff.
    

Detailed description: 
      The study is a prospective double-blind randomized placebo-controlled trial. The study
      population is consisted of patients aged 18-65 years, who applied to the Department of
      Physical Medicine and Rehabilitation, Afyonkarahisar Health Sciences University,
      Afyonkarahisar, Turkey and were diagnosed with rotator cuff tendinopathy and/or partial tear
      in the supraspinatus tendon (< %50) by clinical and MRI examination, and met the inclusion
      criteria. The patients will be randomized into 3 groups using a closed envelope method; 1)
      Single PRP injection, 2) Single placebo injection, and 3) Two PRP injections applied 3 weeks
      apart. All injections will be performed into the subacromial space under ultrasound guidance.
      The same physical therapy program will be given to all groups and will be performed at least
      for 20 minutes daily.

      The randomization will be done using the closed envelope method by a researcher who will not
      perform injections nor evaluate the patients, and to provide blindness, the injectors to be
      used will be covered with non-transparent tapes by the same investigator. The patients, the
      physician to make the evaluations, and the physician to perform injections will be blinded to
      the groups. The solution to be injected will be prepared by another researcher who is not
      blind. PRP injections will be prepared as follows;10 ml of venous blood taken from the
      patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey).
      The obtained blood will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of
      the PRP obtained will be injected into the subacromial space using the lateral subacromial
      injection method under ultrasound guidance. The same amount of blood will be taken for the
      placebo injection group and after the same waiting time 4 ml of 0.9% saline will be injected
      using the same method.

      Ultrasound guided lateral subacromial injection method will be used. For a safer and more
      efficient injection, all applications will be performed in the sagittal axis with the long
      axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz
      linear probe). To obtain an optimal subacromial appearance with shoulder ultrasonography
      (USG), the patients will sit upright with their arms back, internally rotated, shoulder
      hyperextended and elbow flexed to 90° and forearm parallel to the floor. USG in-plane
      technique will be used in the subacromial region to confirm that the needle stays in the
      correct place as it is advanced.

      Shoulder range of motion will be measured. The level of pain at rest, during motion and
      during the night will be evaluated with the visual analog scale (VAS). Constant Murley scale
      and Shoulder Pain and Disability Index (SPADI) will be used for functional evaluation.
      Quality of life will be assessed with Short-Form 36 (SF-36). Upper extremity muscle strength
      will be measured with the Isomed-2000® isokinetic device.

      The participants in single-PRP injection and single-Placebo injection groups will be
      evaluated before the injection and 4 and 12 weeks later. Those in the two PRP injections
      group will be evaluated before the first injection, and 4 and 12 weeks after the second
      injection.
    

Intervention name(s): Single PRP Injection; Multiple PRP Injections; Placebo Injection
Intervention type(s): Other; Other; Other
Intervention description(s): In single-PRP injection group, 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.; In multiple-PRP injection group, two PRP injections will be performed with an interval of 3 weeks. 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained is planned to be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.; In placebo-injection group,10 ml of venous blood will be taken and after the same waiting time 4 ml of 0.9% saline will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet rich plasma ( PRP); Subacromial injection; Rotator cuff tendinopathy; Rotator Cuff Syndrome