- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168477
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)
October 7, 2019 updated by: James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Cockeysville, Maryland, United States, 21030
- Evolution Sports Physiotherapy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: dry needling and spinal manipulation
|
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.
HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).
|
ACTIVE_COMPARATOR: mobilization, exercise, modalities
|
Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder.
Up to 12 treatment sessions over 6 weeks.
Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder.
Up to 12 treatment sessions over 6 weeks.
Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder.
Up to 12 treatment sessions over 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Shoulder Pain (NPRS) (Rating Score)
Time Frame: baseline, 2-weeks, 4-weeks, 3 months
|
Rating Score.
Baseline score must exceed 2/10 to be included in the study.
|
baseline, 2-weeks, 4-weeks, 3 months
|
Change in Shoulder Pain and Disability Index
Time Frame: baseline, 2-weeks, 4-weeks, 3 months
|
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.
|
baseline, 2-weeks, 4-weeks, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Medication Intake (Frequency of medication intake in last week)
Time Frame: baseline, 3 months
|
baseline, 3 months
|
Change in Global Rating of Change Score
Time Frame: 2 week, 4 weeks, 3 months
|
2 week, 4 weeks, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 15, 2017
Primary Completion (ACTUAL)
May 1, 2019
Study Completion (ACTUAL)
May 1, 2019
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 24, 2017
First Posted (ACTUAL)
May 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 9, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAMT0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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