Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

Shoulder Pain Clinical Trial

Official title:

Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03752619
• Other study ID #: IRB17-00643
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2023
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Shoulder pain of >3 months

2. Age>=21

3. Worst pain in the last week>=4 (0-10 scale)

4. Ability to check skin and perform dressing changes, independently or with assistance

5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)

Exclusion Criteria:

1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics

2. 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)

3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)

4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks

5. Uncontrolled bleeding disorder

6. Medical instability based on physician opinion after review of medical information

7. Pregnancy

8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.)

9. Current Worker's compensation claim for the ipsilateral shoulder

10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination

11. 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))

12. Current osseus fracture in ipsilateral arm

13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full)

14. Surgical indication for shoulder treatment based on physician opinion

15. Compromised immune system (immunodeficiency or immunosuppression)

16. 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

17. Patients who have a tape or adhesive allergy

18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only

Related Conditions & MeSH terms

• Bursitis
• Pain, Shoulder
• Rotator Cuff Injuries
• Shoulder Bursitis
• Shoulder Impingement Syndrome
• Shoulder Pain
• Shoulder Tendinitis
• Syndrome
• Tendinopathy

Intervention

Device:
• Contracting Producing Peripheral Nerve Stimulation
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 Stimulation
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.

Other:
• Physical Therapy
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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Univerity of Texas Southwestern	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (10)

Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8. — View Citation

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. — View Citation

Crawshaw 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. — View Citation

Cummins 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. — View Citation

Johansson 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. — View Citation

Johnson 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).

Litaker 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. — View Citation

Morrison 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. — View Citation

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. — View Citation

van 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of Adverse events	Related adverse events are documented as Safety data.	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Primary	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."	Prior 7-days] ; Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Secondary	Change in Brief Pain Inventory (BPI)- Short Form (SF)	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The question asks participants to rate their 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." ." In addition, the question asks the participant to rate how their pain interferes with daily activities where "0" indicates "does not interfere and "10" indicates "completely interferes".	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Secondary	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	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Secondary	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 pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.The question asks 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 = % Minimum Detectable Change (90% confidence) = 13 points (Change less than this may be attributable to measurement error). lower score is better.	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Secondary	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 scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Lower score is better.	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Secondary	Change Mechanical Quantitative Sensory Testing (QST)	used to evaluate central sensitization	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

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