The Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder Impingement

NCT02686671 | Completed

• 1 other identifier: L16-047
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Impingement Syndrome

Keywords

Bursitis; Injections; Shoulder Pain

Outcome Measures

Primary Outcomes (12)

• Pain (NPRS)

  Pain recording pre-injection

  10-30 minutes

• SPADI

  Shoulder function pre-injection

  Immediately pre-injection

• Pain (NPRS)

  Pain recording immediately post-injection

  Immediately post-injection

• Patient Satisfaction

  Patient satisfaction immediately post-injection based on 5-point Likert Scale

  Immediately post-injection

• Pain (NPRS)

  Pain recording 4-7 days post-injection

  4-7 days

• Patient Satisfaction

  Patient satisfaction 4-7 days post-injection based on 5-point Likert Scale

  4-7 days

• Pain (NPRS)

  Pain recording 6-weeks post-injection

  6-weeks

• SPADI

  Shoulder function 6-weeks post-injection

  6-weeks

• Patient Satisfaction

  Patient satisfaction 6-weeks post-injection based on 5-point Likert Scale

  6-weeks

• Subjective Outcome of Success of Injection Assessed by Survey Question

  Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items

  Immediately post-injection

• Subjective Outcome of Success of Injection Assessed by Survey Question

  Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items

  4-7 days

• Subjective Outcome of Success of Injection Assessed by Survey Question

  Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items

  6-weeks

Interventions

Shoulder clinical examination testing OTHER

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age 18 to 80 years
• demonstrate shoulder pain within the C5 distribution during resisted abduction between 2 and 10/10 on NRPS (Wainner et al 2003)
• demonstrate one or more positive tests out of the following clinical examination impingement tests: Neer's sign, Hawkins-Kennedy test, painful arc of arm elevation (Kessel \& Watson 1977; Kelly et al 2010)
• painful resisted abduction of the shoulder (Kelly et al 2010)

You may not qualify if:

• a large three-dimensional limitation of arm motion with any passive motion of the shoulder as compared to the contralateral side, to rule out adhesive capsulitis (Rundquist \& Ludewig 2004; Tveita et al 2008)
• shoulder surgery within the last six months
• a CSI to the involved shoulder within the past three months
• presence of a systemic inflammatory condition
• presence of radiculopathy during active range of motion of the cervical spine (Wainner et al 2003)
• cervical spine as a current primary complaint over the shoulder
• pain reproduction during the Spurling Test (Henry et al 2002; Wainner et al 2003)
• inability to undergo a follow-up phone call
• neurological disorders such as multiple sclerosis, spinal cord injury or spinal cord tumors that would prevent subjects to elevate the arm above the head or perform shoulder movements against resistance
• pregnancy by self-report from the subject.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Advanced Physical Therapy

Anchorage, Alaska, 99507, United States

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Bursitis; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Michel Brismee, ScD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 19, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)