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CompletedNCT03168477Updated Oct 9, 2019

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

An interventional study of dry needling and spinal manipulation in Subacromial Pain Syndrome, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subacromial Pain Syndrome
03

In context

Lead sponsor

Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    dry needling and spinal manipulation

    Other: dry needling · Other: spinal manipulation

  • Active comparator
    mobilization, exercise, modalities

    Other: mobilization · Other: exercise · Other: modalities

Interventions

  • Otherdry 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.

  • Otherspinal manipulation

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

  • Othermobilization

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

  • Otherexercise

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

  • Othermodalities

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

06

What researchers measure

Primary outcomes

  1. Change in Shoulder Pain (NPRS) (Rating Score)

    Rating Score. Baseline score must exceed 2/10 to be included in the study.

    Time frame: baseline, 2-weeks, 4-weeks, 3 months

  2. 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.

    Time frame: baseline, 2-weeks, 4-weeks, 3 months

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

07

Study locations

1 site
  • Evolution Sports Physiotherapy
    Cockeysville, Maryland 21030, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in May 2019, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2017
First posted
May 30, 2017
StartActual
Jun 15, 2017
Primary completionActual
May 1, 2019
CompletionActual
May 1, 2019
Last update
Oct 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03168477
Lead sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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, Alabama Physical Therapy & Acupuncture) — Principal investigator
First posted
May 30, 2017
Start date
Jun 15, 2017
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
Oct 9, 2019

Study contacts

James Dunning, DPT
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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