Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

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

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.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: thoracic mobilization & shoulder mobilization & exercise; Other: shoulder mobilization & exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • Tennessee
    • Elizabethton, Tennessee, United States, 37643
      • Physical Therapy Services
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic Mobilization; thoracic mobilization in addition to shoulder mobilization plus exercise	Other: thoracic mobilization & shoulder mobilization & exercise; Other: shoulder mobilization & exercise
Active Comparator: exercise only; shoulder mobilization plus exercise alone	Other: shoulder mobilization & exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index Change over time	Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks	2 weeks, 4 weeks, discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale change over time	Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks	2 weeks, 4 weeks, discharge
Fear Avoidance Beliefs Questionnaire change over time	Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks	2 weeks, 4 weeks, discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder range of motion change over time	Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks	2 weeks, 4 weeks, discharge
test of resistance change over time - number of repetitions performed	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	2 weeks, 4 weeks, discharge

Collaborators and Investigators

• Sponsor: High Point University
• Collaborators: University of Illinois at Chicago; Walsh University
• Investigators: Principal Investigator: Alexis A Wright, Phd, High Point University

Publications and helpful links

General Publications

• Wright AA, Donaldson M, Wassinger CA, Emerson-Kavchak AJ. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study. J Man Manip Ther. 2017 Sep;25(4):190-200. doi: 10.1080/10669817.2016.1251377. Epub 2016 Nov 7.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Syndrome; Shoulder Impingement Syndrome
• Other Study ID Numbers: 201208-122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No