Blood Flow Restriction Training in Patients With Shoulder Pain
Condition: Rotator Cuff Tendinosis
MeSH terms: Shoulder Pain; Tendinopathy; Rotator Cuff Injuries
Study type: Observational

Summary: 
      This study was planned to investigate the effect of blood flow restriction exercise training
      on shoulder muscle strength and muscle thickness, and to determine the change in pain and
      symptoms in patients with rotator cuff tendinopathy. Patients in the study group will perform
      the rehabilitation exercises with a pneumatic cuff and blood flow restricted. The patients in
      the control group will perform the same exercise program without restricting blood flow.
    

Detailed description: 
      In recent years, one of the popular applications used for muscle hypertrophy and strength
      training is low-intensity exercise training called Blood Flow Restriction Training. This
      exercise training has been shown to allow the benefits of high-intensity training at a much
      lower intensity. Given the light-load nature and strengthening capacity of this training, it
      can provide an effective clinical rehabilitation stimulus without the high levels of joint
      stress. It is suggested that it will be a useful exercise alternative especially in
      individuals who cannot tolerate high-intensity exercise. Especially patients with shoulder
      pain cannot tolerate high-intensity exercises in early rehabilitation.

      This study was planned to investigate the effect of blood flow restriction exercise training
      on shoulder muscle strength and muscle thickness, and to determine the change in pain and
      symptoms in patients with rotator cuff tendinopathy.

      Hypothesis 1: There is a difference between exercise training with blood flow restriction and
      exercise training without blood flow restriction in terms of muscle strength and muscle
      thickness.

      Hypothesis 2: There is a difference between exercise training with blood flow restriction and
      exercise training without blood flow restriction in terms of shoulder pain and shoulder
      function.

      The study was designed as a randomized-controlled. In order to provide an evenly equal number
      of individuals and homogeneous gender distribution in the groups blocking and stratification
      will be used as a randomization method. The sample size was calculated to be an 8% difference
      in muscle thickness at the end of treatment with 80% power and 5% type 1 error. A total of 26
      patients were planned to be included in the study, including 13 volunteers in each group.
      Patients in the study group will perform the determined exercises with a pneumatic cuff and
      blood flow restricted. The patients in the control group will perform the same exercise
      program without restricting blood flow. Informed consent will be obtained from all
      individuals.

      Demographic information (age, gender, body mass index, dominant side, affected side, etc.) of
      all patients will be recorded. Shoulder pain (rest, night and activity- visual analog scale),
      shoulder range of motions (goniometer), shoulder function (Shoulder Pain and Disability
      Index-SPADI), shoulder rotator muscle strength (isokinetic dynamometer-Isomed 2000, D&R
      Ferstl GmbH, Germany) and supraspinatus, infraspinatus, deltoid, biceps, middle trapezius
      muscle thickness, and acromio-humeral distance (ultrasonography- Logiq P5, General Electrics,
      USA) will be evaluated before and after 8 weeks of exercise training.

      In the first session of treatment, initial assessments and patient education to reduce
      shoulder pain (avoiding overhead activities and heavy work, appropriate posture, cold-pack
      application recommendation) will be performed. Exercise training will start in the second
      session. Individuals in the groups will have 2 sessions per week, 16 sessions of exercise
      training for 8 weeks. On other days, patients will continue their home exercises recommended
      by the physiotherapist.

      The blood flow restriction training will be applied to patients in the study group, as
      defined in the literature, by wearing a pneumatic cuff from the most proximal region of the
      upper limb. Occlusion pressure will be calculated according to the formula for each patient.
      [Pressure = 0.4 x (systolic blood pressure) + 2.7 x (shoulder circumference) + 62]. Blood
      flow restriction training will be performed at 30-40% of the arterial occlusion pressure for
      the upper limb and total duration of 15 minutes. The amount of occlusion pressure will be
      re-evaluated every two weeks.

      Statistical analyses will perform using SPSS program. Descriptive statistics will be
      presented with means and standard deviations for numerical data and with numbers (n) and
      percentages (%) for non-numerical data. The suitability of the data obtained from the
      patients to the normal distribution will be evaluated by the Kolmogorov-Smirnov test. In the
      case of the normal distribution of data, comparisons between groups will be tested using
      repeated-measures analysis of variance (two-way ANOVA). When the parametric test conditions
      are not met, before-after differences within the group will be calculated and the Mann
      Whitney U test will be used in the analysis of the differences between the groups. Wilcoxon
      test will be used in intra-group comparisons before and after treatment. In all analyzes, the
      significance value will be determined as p=0.05.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Exercise with blood flow restriction (with a pneumatic cuff).
Other intervention name(s): Blood flow restriction training
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with rotator cuff related shoulder pain (tendinopathy findings in ultrasonographic
        evaluation).
      
Keywords: blood flow restriction training; shoulder pain; rehabilitation