Back to resultsDry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)
Primary Purpose
Subacromial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dry needling
spinal manipulation
mobilization
exercise
modalities
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Adult over the age of 18 years old that is able to read, write and speak English
- Primary complaint of anterolateral shoulder pain lasting longer than 6 weeks
One or more of the following special tests:
- Positive Neer Impingement test-i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized.
- Positive Hawkins-Kennedy test-i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion
Pain with ONE or more of the following active movements and resisted isometric tests
- Pain with active shoulder elevation
- Pain with resisted shoulder external rotation at 90 deg of abduction
- Pain with resisted shoulder abduction in Empty Can Test positon - i.e. 90 deg of shoulder abduction, 30 deg of horizontal adduction (i.e. in scapular plane) and full internal rotation (i.e. thumb down)
Exclusion Criteria:
- Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- History of shoulder injection within the past 3 months.
- History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery.
- Isolated acromioclavicular joint pathology (i.e. the only location of symptoms is localized specifically with one finger directly over the acromioclavicular joint and nowhere else, and reproduced only with acromioclavicular palpation by the examiner.)
- Evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine
- Full-thickness rotator cuff tears (evidenced by MRI and/or positive lag signs)
- Baseline SPADI of not less than 20%
- History of breast cancer on involved side.
- Prior treatments (eg. Acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months.
- Pending litigation for an injury.
- Psychiatric disorders or cognitively impaired
- Pregnancy
Sites / Locations
- Evolution Sports Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dry needling and spinal manipulation
mobilization, exercise, modalities
Arm Description
Outcomes
Primary Outcome Measures
Change in Shoulder Pain (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Shoulder Pain and Disability Index
The SPADI Pain subscale is measured on a 0-130 scale. Greater scores indicate increased pain. Patient must have score of 20% or greater to participate in study on both the pain and disability section.
Secondary Outcome Measures
Change in Global Rating of Change Score
Change in Medication Intake (Frequency of medication intake in last week)
Full Information
NCT ID
NCT03168477
First Posted
May 24, 2017
Last Updated
October 7, 2019
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03168477
Brief Title
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)
Official Title
Electric Dry Needling and Spinal Manipulation vs. Impairment-based Mobilization, Exercise and Interferential Electrotherapy for Patients With Shoulder Impingement (Subacromial Pain Syndrome): a Multi-center Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to compare two different approaches for treating patients with shoulder impingement (subacromial pain syndrome): electric dry needling and spinal manipulation versus impairment-based mobilization, exercise, and interferential electrotherapy. Physical therapists commonly use all of these techniques to treat shoulder impingement (subacromial pain syndrome). This study is attempting to find out if one treatment strategy is more effective than the other.
Detailed Description
Patients with shoulder impingement (subacromial pain syndrome) will be randomized to receive 2 treatment sessions per week for up to 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and spinal manipulation or (2) impairment-based mobilization, exercise and interferential electrotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dry needling and spinal manipulation
Arm Type
Experimental
Arm Title
mobilization, exercise, modalities
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
dry needling
Intervention Description
Dry needling to the supraspinatus (proximal/distal teno-osseus junction and musculotendinous junction under acromion process), deltoid muscle, upper trapezius muscle and levator scapulae muscle on the painful side. Clinicians may also needle the terres major, infraspinatous, rhomboids and thoracic paraspinals, as needed. Up to 12 treatment sessions over 6 weeks.
Intervention Type
Other
Intervention Name(s)
spinal manipulation
Intervention Description
HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).
Intervention Type
Other
Intervention Name(s)
mobilization
Intervention Description
Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
Intervention Type
Other
Intervention Name(s)
modalities
Intervention Description
Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
Primary Outcome Measure Information:
Title
Change in Shoulder Pain (NPRS) (Rating Score)
Description
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Time Frame
baseline, 2-weeks, 4-weeks, 3 months
Title
Change in Shoulder Pain and Disability Index
Description
The SPADI Pain subscale is measured on a 0-130 scale. Greater scores indicate increased pain. Patient must have score of 20% or greater to participate in study on both the pain and disability section.
Time Frame
baseline, 2-weeks, 4-weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change Score
Time Frame
2 week, 4 weeks, 3 months
Title
Change in Medication Intake (Frequency of medication intake in last week)
Time Frame
baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult over the age of 18 years old that is able to read, write and speak English
Primary complaint of anterolateral shoulder pain lasting longer than 6 weeks
One or more of the following special tests:
Positive Neer Impingement test-i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized.
Positive Hawkins-Kennedy test-i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion
Pain with ONE or more of the following active movements and resisted isometric tests
Pain with active shoulder elevation
Pain with resisted shoulder external rotation at 90 deg of abduction
Pain with resisted shoulder abduction in Empty Can Test positon - i.e. 90 deg of shoulder abduction, 30 deg of horizontal adduction (i.e. in scapular plane) and full internal rotation (i.e. thumb down)
Exclusion Criteria:
Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
History of shoulder injection within the past 3 months.
History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery.
Isolated acromioclavicular joint pathology (i.e. the only location of symptoms is localized specifically with one finger directly over the acromioclavicular joint and nowhere else, and reproduced only with acromioclavicular palpation by the examiner.)
Evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine
Full-thickness rotator cuff tears (evidenced by MRI and/or positive lag signs)
Baseline SPADI of not less than 20%
History of breast cancer on involved side.
Prior treatments (eg. Acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months.
Pending litigation for an injury.
Psychiatric disorders or cognitively impaired
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evolution Sports Physiotherapy
City
Cockeysville
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)
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