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

NCT03168477 | Completed

• 1 other identifier: AAMT0012
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Global Rating of Change Score

  2 week, 4 weeks, 3 months

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

  baseline, 3 months

Study Arms (2)

dry needling and spinal manipulation

EXPERIMENTAL

Other: dry needling; Other: spinal manipulation

mobilization, exercise, modalities

ACTIVE COMPARATOR

Other: mobilization; Other: exercise; Other: modalities

Interventions

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.

dry needling and spinal manipulation

spinal manipulation OTHER

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

dry needling and spinal manipulation

mobilization OTHER

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

mobilization, exercise, modalities

exercise OTHER

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

mobilization, exercise, modalities

modalities OTHER

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

mobilization, exercise, modalities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Evolution Sports Physiotherapy

Cockeysville, Maryland, 21030, United States

Location

MeSH Terms

Interventions

Dry Needling; Manipulation, Spinal; Exercise

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 15, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)