The Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder Impingement
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Observational

Summary: 
      Shoulder pain is very common. People receive injections in their shoulder for their painful
      shoulder. However, investigators do not know which patient with shoulder pain responds best
      to an injection in the shoulder.

      Investigators plan to use a "Pull Test" where the researcher will pull on the arm and resist
      shoulder movement to investigate if it helps to determine which patients have better pain
      relief with the shoulder injection.

      The study will take place in Anchorage, Alaska. There will be two phases in the study. For
      each phase, the subjects will complete some questionnaires. Phase I "Reliability Testing"
      will test how consistent two licensed physical therapists are giving shoulder examination
      tests and the Pull Test. Phase II "Pull Test" will comprise shoulder examination findings,
      including the Pull Test, done before and after one shoulder injection performed as normal
      standard of care by a licensed physician.

      For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from
      Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain
      scheduled to have a shoulder injection will be asked by an investigator if they wish to
      participate in the study until a number of 30 subjects qualify for the study. Phase II of the
      study will include shoulder tests before and about 20 minutes after the injection and a 4- to
      7-day, as well as a 6-week, phone follow-up.

      Statistics will be used to analyze the data.
    

Detailed description: 
      Background: Subacromial impingement syndrome (SAIS) is one of the most common causes of
      shoulder pain. The subacromial-subdeltoid (SAD) bursa is regarded as a common potential
      shoulder pain generator. Differentiating the specific acromio-humeral interval (AHI) tissues
      responsible for pain generation is challenging and no specific clinical examination testing
      exists to differentiate SAD bursa from the rotator cuff tendons as pain generators.
      Corticosteroid injection (CSI) within the AHI is a mainstay of treatment for SAD bursitis and
      rotator cuff tendinopathy. No study to date has examined a specific test associated with
      successful responsiveness from a CSI targeting the SAD bursa in the AHI in subjects with
      shoulder pain.

      Purpose: To investigate (1) Phase I: the reliability of the shoulder examination tests and of
      the Pull Test; and (2) Phase II: if a positive shoulder traction test during resistive
      shoulder abduction, the "Pull Test", correlates with a successful outcome of an AHI CSI
      targeting the SAD bursa.

      Aims: To evaluate: (1) the reliability of the Pull Test; (2) if a positive Pull Test
      correlates with successful pain and satisfaction outcomes immediately following, 4 to 7 days
      following, and 6 weeks following an AHI CSI targeting the SAD bursa in subjects with
      musculoskeletal shoulder pain (3) if a positive Pull Test correlates with a successful
      functional outcome 6 weeks following an AHI CSI targeting the SAD bursa in subjects with
      musculoskeletal shoulder pain and (4) the sensitivity, specificity, accuracy, positive and
      negative predictive values of the Pull Test to identify subjects with shoulder pain likely to
      successfully respond to an AHI CSI targeting the SAD bursa

      Design: Methodological and exploratory correlational study.

      Methods: Phase I (reliability testing): A sample of convenience of up to 20 subjects treated
      at Advanced Physical Therapy of Alaska for shoulder pain will be recruited to participate.
      Two licensed physical therapists will test the reliability of the shoulder examination tests
      and of the Pull Test. Phase II (Pull Test): A consecutive sample of convenience of subjects
      treated by physicians from Advanced Pain Centers of Alaska for musculoskeletal shoulder pain
      and scheduled for a subacromial CSI as part of their care will be asked to participate in the
      study. The study will end when a minimum of 30 subjects qualify for the research study. Those
      subjects agreeing to participate will then be evaluated using shoulder clinical examination
      including resistive shoulder abduction with and without a humeral traction (Pull Test).
      Functional status will be measured using the Shoulder Pain and Disability Index (SPADI).
      Following the CSI, one investigator blinded to the results of the pre-injection clinical
      examination will administer the clinical examination tests performed prior to the AHI CSI and
      record shoulder pain (NPRS) and subject satisfaction about the change in pain following the
      CSI. Subjects will then receive standardized home instructions. A 4- to 7-day follow-up phone
      call to determine shoulder pain (NPRS) and satisfaction and 6-week follow-up phone call to
      determine satisfaction and subjects' compliance to the home instructions, shoulder pain
      (NPRS) at rest and during arm elevation, SPADI score and subject satisfaction will be
      initiated.

      Statistical Analysis: Reliability testing will be assessed using kappa and intraclass
      correlation coefficients. Validity testing of the Pull Test will be performed to determine
      the sensitivity, specificity, accuracy, negative and positive predictive values for the
      comparison of Pull Test outcome and the pain and functional changes observed following
      administration of the AHI CSI. Chi-square (2x2 contingency tables) and odds ratios will then
      be calculated to evaluate if the outcomes of the Pull Test (binary: positive versus negative)
      are correlated with successful pain and functional outcome changes following the AHI CSI
      (successful outcome, Yes versus No) immediately following, at 4- to 7-days following, and at
      6-weeks following the AHI CSI.
    

Intervention name(s): Shoulder clinical examination testing
Intervention type(s): Other
Intervention description(s): Shoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A consecutive sample of convenience of subjects treated by physicians from Advanced Pain
        Centers of Alaska for musculoskeletal shoulder pain and scheduled for a subacromial CSI as
        part of their care will be asked to participate in the study. The study will end when a
        minimum of 30 subjects qualify for the research study.
      
Keywords: Bursitis; Injections; Shoulder Pain