Subacromial Pain SyndromeNCT03168477
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)
A study testing dry needling, spinal manipulation and mobilization in people with Subacromial Pain Syndrome, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- dry needling, spinal manipulation and mobilization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Evolution Sports Physiotherapy
Cockeysville, Maryland, 21030
About this study
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
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.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- dry needling, spinal manipulation, mobilization, exercise, modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
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 manipulationOther
HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).
mobilizationOther
Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
exerciseOther
Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
modalitiesOther
Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| dry needling and spinal manipulation | Experimental | Not described Receives: Other: dry needling; Other: spinal manipulation |
| mobilization, exercise, modalities | Active comparator | Not described Receives: Other: mobilization; Other: exercise; Other: modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain (NPRS) (Rating Score)
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Measured: 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.
Measured: baseline, 2-weeks, 4-weeks, 3 months
Secondary outcomes (2)
Change in Global Rating of Change Score
Measured: 2 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Jun 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168477
- Sponsor's protocol ID
- AAMT0012
- Status last verified
- Oct 2019
- First submitted
- 24 May 2017
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03168477
- Acronym / sponsor ID
- AAMT0012
- Conditions
- Subacromial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling and spinal manipulation | Experimental | Other: dry needling, Other: spinal manipulation |
| mobilization, exercise, modalities | Active comparator | Other: mobilization, Other: exercise, Other: modalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Pain with ONE or more of the following active movements and resisted isometric tests
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingDry 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. | Other | dry needling and spinal manipulation |
| spinal manipulationHVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3). | Other | dry needling and spinal manipulation |
| mobilizationImpairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks. | Other | mobilization, exercise, modalities |
| exerciseImpairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks. | Other | mobilization, exercise, modalities |
| modalitiesInterferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks. | Other | mobilization, exercise, modalities |
Primary outcome
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.
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.
2 secondary outcomes
Change in Global Rating of Change Score
Time frame: 2 week, 4 weeks, 3 months
Change in Medication Intake (Frequency of medication intake in last week)
Time frame: baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Subacromial Pain Syndrome
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Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
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Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
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Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Dunning, DPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling, spinal manipulation and mobilization in people with Subacromial Pain Syndrome, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain (NPRS) (Rating Score) (time frame: baseline, 2-weeks, 4-weeks, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.