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NCT Number: NCT01753271

Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement.

Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side

Exclusion criteria

  • Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded

Treatment and study plan

thoracic mobilization & shoulder mobilization & exercise

Other

shoulder mobilization & exercise

Other

Primary outcomes

  1. Shoulder Pain and Disability Index Change over time

    Time frame: 2 weeks, 4 weeks, discharge

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

Secondary outcomes

  1. Numeric Pain Rating Scale change over time

    Time frame: 2 weeks, 4 weeks, discharge

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

  2. Fear Avoidance Beliefs Questionnaire change over time

    Time frame: 2 weeks, 4 weeks, discharge

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

Other outcomes

  1. Shoulder range of motion change over time

    Time frame: 2 weeks, 4 weeks, discharge

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

  2. test of resistance change over time - number of repetitions performed

    Time frame: 2 weeks, 4 weeks, discharge

    The test is performed by asking the patient to hold the shoulder at 90 degrees of shoulder flexion and follow a 20cm wide spiral using their affected arm. The patient is asked to complete as many spiral movements as possible until stopped secondary to pain. The maximum number of repetitions to be performed is 20.

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

Sponsors and collaborators

Lead sponsor

High Point University

Other

Collaborators

  • University of Illinois at Chicago
  • Walsh University

Registry information

Official study title

Subacute Effects of Cervicothoracic Spinal Manipulation in Addition to Shoulder Manual Therapy Plus Exercise Intervention in Individuals With Subacromial Impingement Syndrome: a Randomized, Controlled Clinical Trial Pilot Study

Important dates

Study start
2012
Primary completion
2015
First posted
Dec 20, 2012
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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