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NCT Number: NCT03168477

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evolution Sports Physiotherapy

Cockeysville, Maryland, 21030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

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

Other

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

Mobilization

Other

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

Exercise

Other

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

modalities

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Global Rating of Change Score

    Time frame: 2 week, 4 weeks, 3 months

  2. Change in Medication Intake (Frequency of medication intake in last week)

    Time frame: baseline, 3 months

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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