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

NCT ID: NCT03168477

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2019-05-01

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.

Conditions

Subacromial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dry needling and spinal manipulation

Group Type: EXPERIMENTAL

dry needling

Intervention Type: OTHER

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

Intervention Type: OTHER

HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).

mobilization, exercise, modalities

Group Type: ACTIVE_COMPARATOR

mobilization

Intervention Type: OTHER

Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.

exercise

Intervention Type: OTHER

Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.

modalities

Intervention Type: OTHER

Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.

Interventions

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.

Intervention Type: OTHER

spinal manipulation

HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).

Intervention Type: OTHER

mobilization

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

exercise

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

modalities

Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role: lead

Responsible Party

James Dunning, DPT, MSc, FAAOMPT

Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Dunning, DPT

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

Evolution Sports Physiotherapy

Cockeysville, Maryland, United States

Countries

United States

Other Identifiers

AAMT0012

Identifier Type: -

Identifier Source: org_study_id