Shoulder PainNCT03752619
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
A study testing Contracting Producing Peripheral Nerve Stimulation, Non Contracting Producing Peripheral Nerve Stimulation and Physical Therapy in people with Shoulder Pain and Shoulder Impingement Syndrome, run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis
- What is being tested?
- Contracting Producing Peripheral Nerve Stimulation, Non Contracting Producing Peripheral Nerve Stimulation and Physical Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain of >3 months
- Age>=21
- Worst pain in the last week>=4 (0-10 scale)
- Ability to check skin and perform dressing changes, independently or with assistance
- Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Who cannot join
- Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics
- Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome)
- Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)
- Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks
- Uncontrolled bleeding disorder
- Medical instability based on physician opinion after review of medical information
Show all 18Show fewer
- Pregnancy
- Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.)
- Current Worker's compensation claim for the ipsilateral shoulder
- Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination
- Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person))
- Current osseus fracture in ipsilateral arm
- Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full)
- Surgical indication for shoulder treatment based on physician opinion
- Compromised immune system (immunodeficiency or immunosuppression)
- Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System
- Patients who have a tape or adhesive allergy
- Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Univerity of Texas Southwestern
Dallas, Texas, 75390
About this study
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Read the detailed description
The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of all shoulder pain. Approximately 35% of patients who present with subacromial impingement syndrome (SIS) are refractory to conservative management. For patients who have failed conservative management, there are no established treatments to reduce the pain. The long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS) that was refractory to conservative treatment that showed 60% of participants had successful treatment of pain that lasted at least 3 months. Thus, the primary objective of this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the treatment of subacromial impingement syndrome (SIS), and to determine which characteristics can predict successful treatment with peripheral nerve stimulation (PNS). In order to accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS) to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis, Pain, Shoulder
- Being tested
- Contracting Producing Peripheral Nerve Stimulation, Non Contracting Producing Peripheral Nerve Stimulation, Physical Therapy
- Keywords
- peripheral nerve stimulation, Sprint, stimulation
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contracting Producing Peripheral Nerve StimulationDevice
Also called Intramuscular Peripheral Nerve Stimulation, Intramuscular Electrical Nerve Stimulation, SMARTPATCH System
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
Non Contracting Producing Peripheral Nerve StimulationDevice
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
Physical TherapyOther
All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.
| Study group | Role | What they receive |
|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Experimental | This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. Receives: Device: Contracting Producing Peripheral Nerve Stimulation; Other: Physical Therapy |
| Non Contracting Producing Peripheral Nerve Stimulation | Active comparator | This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. Receives: Device: Non Contracting Producing Peripheral Nerve Stimulation; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in - Short Form (SF) Question 3 (BPI-SF3)
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Measured: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
Secondary outcomes (3)
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds).
Measured: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: _____/ 80 x 100 = %. Total SPADI score: _____ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%).
Measured: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Quality of Life - Short Form - 12(QoL - SF 12)
Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health.
Measured: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Mar 2019
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Principal investigator, Richard Wilson, MD, MetroHealth Medical Center
- Investigators
- Richard D Wilson, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752619
- Sponsor's protocol ID
- IRB17-00643
- Status last verified
- Jun 2025
- First submitted
- 20 Nov 2018
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
PubMed 9924205Johnson MP, Crossley KL, O'neil ME, Al-Zakwani IS. Estimates of Direct Health Care Expenditures Among Individuals With Shoulder Dysfunction in the United States J Ortho Sports Phys Ther 2005;35(1,A4).
Cadogan A, Laslett M, Hing WA, McNair PJ, Coates MH. A prospective study of shoulder pain in primary care: prevalence of imaged pathology and response to guided diagnostic blocks. BMC Musculoskelet Disord. 2011 May 28;12:119. doi: 10.1186/1471-2474-12-119.
PubMed 21619663van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
PubMed 8546527Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
PubMed 15808040Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Aldous SJ, Conaghan PG. Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial. BMJ. 2010 Jun 28;340:c3037. doi: 10.1136/bmj.c3037.
PubMed 20584793Cummins CA, Sasso LM, Nicholson D. Impingement syndrome: temporal outcomes of nonoperative treatment. J Shoulder Elbow Surg. 2009 Mar-Apr;18(2):172-7. doi: 10.1016/j.jse.2008.09.005. Epub 2008 Dec 18.
PubMed 19095464Johansson K, Oberg B, Adolfsson L, Foldevi M. A combination of systematic review and clinicians' beliefs in interventions for subacromial pain. Br J Gen Pract. 2002 Feb;52(475):145-52.
PubMed 11885825Litaker D, Pioro M, El Bilbeisi H, Brems J. Returning to the bedside: using the history and physical examination to identify rotator cuff tears. J Am Geriatr Soc. 2000 Dec;48(12):1633-7. doi: 10.1111/j.1532-5415.2000.tb03875.x.
PubMed 11129754Morrison DS, Frogameni AD, Woodworth P. Non-operative treatment of subacromial impingement syndrome. J Bone Joint Surg Am. 1997 May;79(5):732-7. doi: 10.2106/00004623-199705000-00013.
PubMed 9160946Pierson CJ, Jain NB, Hansen K, Hisel TZ, Frost SK, Whitehair VC, Konda C, DeVahl JM, Van Acker G 3rd, DiLorenzo DR, Chae J, Gunzler DD, Kim CH, Wilson RD. Efficacy of Standardized Physical Therapy and Axillary Motor Stimulation for Chronic Shoulder Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2026 Mar 1;105(3S Suppl 2):S96-S104. doi: 10.1097/PHM.0000000000002863.
PubMed 41707131Pierson C, Wilson R, Brewer-Mixon K, Tzen YT, Williamson J, Hansen K, Hisel T, Jain N. Pressure pain sensitivity is independent of structural pathology in patients with subacromial pain syndrome: a cross-sectional analysis. Pain Med. 2025 Apr 1;26(4):173-179. doi: 10.1093/pm/pnae123.
PubMed 39589920Cleland T, Jain NB, Chae J, Hansen KM, Hisel TZ, Gunzler DD, Whitehair VC, Kim CH, Wilson RD. The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain. Trials. 2020 Mar 6;21(1):248. doi: 10.1186/s13063-020-4174-x.
PubMed 32143732
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
- ClinicalTrials.gov ID
- NCT03752619
- Acronym / sponsor ID
- IRB17-00643
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis, Pain, Shoulder
- Keywords
- peripheral nerve stimulation, Sprint, stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Detailed description
The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of all shoulder pain. Approximately 35% of patients who present with subacromial impingement syndrome (SIS) are refractory to conservative management. For patients who have failed conservative management, there are no established treatments to reduce the pain. The long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS) that was refractory to conservative treatment that showed 60% of participants had successful treatment of pain that lasted at least 3 months. Thus, the primary objective of this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the treatment of subacromial impingement syndrome (SIS), and to determine which characteristics can predict successful treatment with peripheral nerve stimulation (PNS). In order to accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS) to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraction Producing Peripheral Nerve Stimulation | Experimental | Device: Contracting Producing Peripheral Nerve Stimulation, Other: Physical TherapyThis group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. |
| Non Contracting Producing Peripheral Nerve Stimulation | Active comparator | Device: Non Contracting Producing Peripheral Nerve Stimulation, Other: Physical TherapyThis group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Shoulder pain of >3 months
- Age>=21
- Worst pain in the last week>=4 (0-10 scale)
- Ability to check skin and perform dressing changes, independently or with assistance
- Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Key exclusion criteria (18 listed)
- Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics
- Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome)
- Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)
- Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks
- Uncontrolled bleeding disorder
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 |
|---|---|---|
| Contracting Producing Peripheral Nerve StimulationAlso: Intramuscular Peripheral Nerve Stimulation, Intramuscular Electrical Nerve Stimulation, SMARTPATCH SystemThe stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. | Device | Contraction Producing Peripheral Nerve Stimulation |
| Non Contracting Producing Peripheral Nerve StimulationThe stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. | Device | Non Contracting Producing Peripheral Nerve Stimulation |
| Physical TherapyAll participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands. | Other | Contraction Producing Peripheral Nerve Stimulation, Non Contracting Producing Peripheral Nerve Stimulation |
Primary outcome
Change in - Short Form (SF) Question 3 (BPI-SF3)
Time frame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
3 secondary outcomes
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Quality of Life - Short Form - 12(QoL - SF 12)
Time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9924205Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
- BackgroundJohnson MP, Crossley KL, O'neil ME, Al-Zakwani IS. Estimates of Direct Health Care Expenditures Among Individuals With Shoulder Dysfunction in the United States J Ortho Sports Phys Ther 2005;35(1,A4).
- Background: PubMed 21619663Cadogan A, Laslett M, Hing WA, McNair PJ, Coates MH. A prospective study of shoulder pain in primary care: prevalence of imaged pathology and response to guided diagnostic blocks. BMC Musculoskelet Disord. 2011 May 28;12:119. doi: 10.1186/1471-2474-12-119.
- Background: PubMed 8546527van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
- Background: PubMed 15808040Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
- Background: PubMed 20584793Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Aldous SJ, Conaghan PG. Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial. BMJ. 2010 Jun 28;340:c3037. doi: 10.1136/bmj.c3037.
- Background: PubMed 19095464Cummins CA, Sasso LM, Nicholson D. Impingement syndrome: temporal outcomes of nonoperative treatment. J Shoulder Elbow Surg. 2009 Mar-Apr;18(2):172-7. doi: 10.1016/j.jse.2008.09.005. Epub 2008 Dec 18.
- Background: PubMed 11885825Johansson K, Oberg B, Adolfsson L, Foldevi M. A combination of systematic review and clinicians' beliefs in interventions for subacromial pain. Br J Gen Pract. 2002 Feb;52(475):145-52.
- Background: PubMed 11129754Litaker D, Pioro M, El Bilbeisi H, Brems J. Returning to the bedside: using the history and physical examination to identify rotator cuff tears. J Am Geriatr Soc. 2000 Dec;48(12):1633-7. doi: 10.1111/j.1532-5415.2000.tb03875.x.
- Background: PubMed 9160946Morrison DS, Frogameni AD, Woodworth P. Non-operative treatment of subacromial impingement syndrome. J Bone Joint Surg Am. 1997 May;79(5):732-7. doi: 10.2106/00004623-199705000-00013.
- Derived from this study: PubMed 41707131Pierson CJ, Jain NB, Hansen K, Hisel TZ, Frost SK, Whitehair VC, Konda C, DeVahl JM, Van Acker G 3rd, DiLorenzo DR, Chae J, Gunzler DD, Kim CH, Wilson RD. Efficacy of Standardized Physical Therapy and Axillary Motor Stimulation for Chronic Shoulder Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2026 Mar 1;105(3S Suppl 2):S96-S104. doi: 10.1097/PHM.0000000000002863.
- Derived from this study: PubMed 39589920Pierson C, Wilson R, Brewer-Mixon K, Tzen YT, Williamson J, Hansen K, Hisel T, Jain N. Pressure pain sensitivity is independent of structural pathology in patients with subacromial pain syndrome: a cross-sectional analysis. Pain Med. 2025 Apr 1;26(4):173-179. doi: 10.1093/pm/pnae123.
- Functional Electrical Stimulation (FES)CenterLink provided by the sponsor.
- Metrohealth clinic trialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
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.
Richard D Wilson, MD principal investigator
MetroHealth Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contracting Producing Peripheral Nerve Stimulation, Non Contracting Producing Peripheral Nerve Stimulation and Physical Therapy in people with Shoulder Pain and Shoulder Impingement Syndrome, run by MetroHealth Medical Center at 2 sites 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 5 inclusion and 18 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 - Short Form (SF) Question 3 (BPI-SF3) (time frame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752619, which also lists 13 linked publications.
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 17 Jun 2025.