Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)

Subacromial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168477
• Other study ID #: AAMT0012
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: October 2019
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult over the age of 18 years old that is able to read, write and speak English

2. Primary complaint of anterolateral shoulder pain lasting longer than 6 weeks

3. One or more of the following special tests:

1. Positive Neer Impingement test—i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized.

2. Positive Hawkins-Kennedy test—i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion

4. Pain with ONE or more of the following active movements and resisted isometric tests

1. Pain with active shoulder elevation

2. Pain with resisted shoulder external rotation at 90 deg of abduction

3. 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:

1. 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.

2. History of shoulder injection within the past 3 months.

3. History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery.

4. 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.)

5. Evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine

6. Full-thickness rotator cuff tears (evidenced by MRI and/or positive lag signs)

7. Baseline SPADI of not less than 20%

8. History of breast cancer on involved side.

9. Prior treatments (eg. Acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months.

10. Pending litigation for an injury.

11. Psychiatric disorders or cognitively impaired

12. Pregnancy

Related Conditions & MeSH terms

• Somatoform Disorders
• Subacromial Pain Syndrome
• Syndrome

Intervention

Other:
• dry needling
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.
• spinal manipulation
HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).
• mobilization
Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
• exercise
Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
• modalities
Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.

Locations

Country	Name	City	State
United States	Evolution Sports Physiotherapy	Cockeysville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shoulder Pain (NPRS) (Rating Score)	Rating Score. Baseline score must exceed 2/10 to be included in the study.	baseline, 2-weeks, 4-weeks, 3 months
Primary	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.	baseline, 2-weeks, 4-weeks, 3 months
Secondary	Change in Global Rating of Change Score		2 week, 4 weeks, 3 months
Secondary	Change in Medication Intake (Frequency of medication intake in last week)		baseline, 3 months