Ultrasound-guided glenohumeral joint injections for shoulder pain in ALS: A Case Series

doi:10.21203/rs.3.rs-1990390/v1

INTRODUCTION: Shoulder pain is a common secondary impairment for people living with ALS (PALS). Decreased range of motion (ROM) from weakness can lead to shoulder pathology, which can result in debilitating pain. Shoulder pain may limit PALS from participating in activities of daily living and may have a negative impact on quality of life. This case series explores the efficacy of glenohumeral joint injections for management of shoulder pain due to adhesive capsulitis in PALS.

METHODS: PALS with shoulder pain were referred to sports medicine certified physiatrists for diagnostic evaluation and management. They completed the Revised ALS Functional Rating Scale and a questionnaire asking about their pain levels and how it impacts sleep, function, and quality of life at baseline pre-injection, one-week post-injection, one-month and three-months post-injection.

RESULTS: We present 5 cases of PALS who were diagnosed with adhesive capsulitis and underwent glenohumeral joint injections. Though only one PALS reported complete symptom resolution, all had at least partial symptomatic improvement during the observation period. No complications were observed.

CONCLUSIONS: PALS require a comprehensive plan to manage shoulder pain. Glenohumeral joint injections are safe and effective for adhesive capsulitis in PALS, but alone may not completely resolve shoulder pain. Additional therapies to improve ROM and reduce pain should be considered.

Amyotrophic Lateral Sclerosis

Motor Neuron Disease

Shoulder Pain

Frozen Shoulder

Adhesive Capsulitis

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease.¹ Management of ALS is largely focused on symptom management as current FDA-approved treatments to slow disease progression have modest efficacy.¹

ALS symptoms include muscle weakness and atrophy, reduced range of motion, spasticity, and cramping leading to progressive disability. Pain is a common secondary complication of ALS from musculoskeletal dysfunction due to limited mobility, loss of range of motion, and difficulty with positioning in bed, chairs, or wheelchairs.² Progressive, often non-uniform, weakness likely also contributes by disrupting agonist-antagonist muscle pair equilibrium leading to increased stress on the joint and surrounding structures. Pain negatively affects quality of life for both PALS and their caregivers.^2,3,4,5,6,7 The most commonly reported loci of pain in PALS are the lower back, neck, legs, and shoulders.^2,8 Shoulder pain is reported by roughly 20% of the total ALS population.⁸ Many PALS develop shoulder pain due to weakness of the peri-scapular muscles with subsequent loss of range of motion, subluxation, and development of shoulder pathology, including adhesive capsulitis or ‘frozen shoulder’.

Adhesive capsulitis is a complex disorder that involves pain and restricted range of motion (ROM) of the shoulder⁹ and can lead to considerable disability. The capsule surrounding the glenohumeral (GH) joint stiffens and becomes inflamed, which results in decreased ROM at the shoulder. There are overlapping stages of adhesive capsulitis. In the earlier stages, patients present with severely restricted ROM and significant pain, often in the absence of injury. In the later stages, restrictions in ROM remain, but with improvements in pain. As ROM and pain improve, there may be continued evidence of a tight joint space, but no evidence of synovitis.¹⁰Adhesive capsulitis is largely a clinical diagnosis, with any imaging done to exclude other potential diagnoses.⁹

For individuals without ALS, the management of adhesive capsulitis involves exercises and supervised physical therapy focused on gentle ROM and periscapular stabilization. First-line medications typically prescribed to treat pain in ALS are non-steroidal anti-inflammatory agents (NSAIDs) and non-opioid analgesics.⁴,¹² Early corticosteroid injection to the GH joint should be considered for moderate to severe symptoms,^13,14as there is evidence suggesting improved outcomes with earlier steroid injection.¹⁵This in-clinic procedureis fast and safe. It is routinely performed in the seated position, which is preferable for PALS who may be in a power wheelchair and/or have limited tolerance of the supine position. Adverse effects such as bleeding or infection are rare when performed with proper clean technique. In cases where conservative measures are ineffective, surgical interventions such as arthroscopic release and manipulation under anesthesia are considered, especially in the early stages when the pain can be debilitating.^16,17

To the best of our knowledge, there is no evidence from controlled trials that would substantiate a standard best practice for addressing shoulder pain in people with ALS. Thus, management of shoulder pain has long been based on individual clinician’s experience and preferences with very little empirically derived evidence to support the implementation of one therapeutic method over another. When a PALS is presenting with progressive shoulder pain, accompanying restrictions in ROM, and no history of trauma, referral to physiatry can help assess the pain generator (e.g., adhesive capsulitis versus other shoulder pathology) and help guide intervention. There is growing evidence to support the use of GH steroid injections for adhesive capsulitis for those without ALS^{13,14,15,16,17} but to our knowledge, no evidence for its use in individuals with ALS.

The purpose of this study was to assess the efficacy of ultrasound-guided GH joint injections for treating shoulder pain due to adhesive capsulitis in PALS. We present a case series of 5 patients referred for physiatric evaluation and consideration of GH joint injections as part of their clinical care. Participants completed surveys pre- and post-injections regarding their pain levels and impact on function.

Participants were recruited from the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and the Northwestern University Feinberg School of Medicine ALS Clinic. Eligible participants were informed of the study and study staff consented interested participants. Both the Mass General Brigham Institutional Review Board (IRB) and the Northwestern IRB approved this study.

Participants were asked to participate in this study if they had ALS and a clinical suspicion of adhesive capsulitis (pain with restricted ROM, without history of trauma). Participants were seen by physiatrists certified in Sports Medicine by the American Board of Physical Medicine and Rehabilitation for diagnostic confirmation and consideration of GH steroid injections. The physiatrists completed a history, physical and ultrasound examinations to assess likelihood of adhesive capsulitis versus other common shoulder pathologies (such as rotator cuff or biceps tendinopathy, periscapular myofascial pain, etc.). Once clinical diagnosis of adhesive capsulitis was established, ultrasound-guided GH joint injection was performed. For Cases 1-3, a solution of 4mL of 1% Lidocaine and 1mL (40mg) of Kenalog was injected into the affected joints. For Cases 4 and 5, a solution of 2 mL of 1% Lidocaine, 2 mL 0.25% Bupivacaine, and 1mL (40mg) of Kenalog was injected into the involved joints. Differences were due to preference of the physiatrist performing the intervention. Study duration was from May 2019 through August 2021. Enrollment was limited by the COVID-19 pandemic, as sites had temporary holds on observational studies, and patient care shifted to telemedicine visits.

Participants were asked to complete the revised ALS Functional Rating Scale (ALSFRS-R) and a questionnaire that assessed pain, sleep, function, and quality of life (Supplementary Materials) at baseline prior to undergoing the GH joint injections. They were then asked to complete the same questionnaires at one week post injection and one month post injection. There was an optional phone call at 3 months to complete the same questionnaires.

Electronic medical record review was available for all participants, from which information regarding their ALS diagnosis, disease duration and current functional status was gathered.

Of 9 participants enrolled in the study, 3 initially agreed but ultimately declined the referral for GH joint injections and were provided with ROM and stretching exercises by clinic physical therapists. Follow-up of these individuals was not pursued as part of this study. Another participant was seen by physiatry: diagnostic evaluation pointed to myofascial pain with muscle spasms as the most likely pain generator. For this reason, the participant underwent bilateral trapezius, infraspinatus, levator scapulae trigger point injections rather than GH joint injections. This participant did have resolution of his shoulder pain 18 days post injection, but this was not sustained 2 months post-injection. We report on the remaining 5 participants who were diagnosed by sports medicine certified physiatrists with adhesive capsulitis and did undergo ultrasound guided GH joint steroid injections. None of the participants experienced procedure-related complications. Average pain scores and impact on sleep and quality of life for each participant are shown in Table 1. Complete data for each participant are shown in Supplementary Tables 1-5.

Case 1.

Participant was a 41-year-old female with limb onset sporadic ALS who used a wheelchair for mobility and was dependent on caregivers for activities of daily living (ADLs). ALS symptom onset was over three years prior with left hand weakness. She presented with atraumatic bilateral shoulder pain, right greater than left, with passive range of motion restrictions. She was taking NSAIDs as needed and undergoing physical therapy with shoulder range of motion and stretching exercises. Physiatry evaluation confirmed the diagnosis of adhesive capsulitis and she underwent right GH joint injection with ultrasound guidance. Post injection, she demonstrated improvements in shoulder pain, which were sustained at the 3-month visit, as well as sustained improvements in sleep, function, and quality of life. (Supplementary Table 1)

Case 2.

Participant was a 42-year-old male with limb onset sporadic ALS who was ambulatory with single point cane and had modified independence with ADLs. ALS onset was over two years prior with lower extremity weakness. He presented with atraumatic right shoulder pain that started a few months prior, with limited ROM. He was not taking any medications and was not participating in physical therapy. He had been prescribed shoulder range of motion and stretching exercises at multidisciplinary clinic, but was unable to perform due to pain. Physiatry evaluation confirmed the diagnosis of adhesive capsulitis and he underwent right GH joint injection with ultrasound guidance. Post injection, he demonstrated improvements in shoulder pain, which were sustained at the 1-month visit, as well as improvements in sleep, function and quality of life (Supplementary Table 2). He initiated a stretching program for bilateral shoulders post-injection.

Case 3.

Participant was a 57-year-old male with limb onset sporadic ALS. ALS symptom onset was over three years prior with lower extremity weakness. He was ambulatory without an assistive device and required assistance with ADLs due to bilateral upper extremity weakness. He presented with bilateral atraumatic shoulder pain, left greater than right. He had been prescribed shoulder range of motion and stretching exercises at multidisciplinary clinic, but was unable to perform due to pain. He was not taking any pain medications. Physiatry evaluation confirmed the diagnosis of adhesive capsulitis and he underwent bilateral GH joint injections with ultrasound guidance. Overall pain was improved in bilateral shoulders post-injection, and this was sustained at the 3-month visit. At one month, pain was not impacting sleep, function, and quality of life, but this was not sustained at three-months (Supplementary Table 3). He was stretching at the 1-month mark, but this was not sustained at 3-months.

Case 4.

Participant was a 49-year-old male with limb onset sporadic ALS. He was power wheelchair dependent for community mobility and used either a cane or power wheelchair for household mobility. He had modified independence with ADLs. He presented with 6 months of progressively worsening atraumatic bilateral anterolateral shoulder pain and stiffness, left greater than right. He had passive and active ROM restrictions bilaterally. He had been taking ibuprofen as needed for several years. He had been prescribed shoulder range of motion and stretching exercises at multidisciplinary clinic, but was not able to comply due to pain. He underwent bilateral GH joint injections with ultrasound guidance. He exhibited improvements in impact of shoulder pain that lasted only about 1 month, but improvements on his quality of life and function were largely sustained at the 3-month follow-up (Supplementary Table 4).

Case 5.

Participant is a 58-year-old female with limb onset sporadic ALS. She was ambulatory and required assistance with ADLs due to upper extremity weakness. She presented with atraumatic left shoulder pain and stiffness for 2 months. She managed her pain with nightly dose of ibuprofen and had not yet started physical therapy prior to initial referral for injection. She had limited active and passive shoulder ROM. She underwent left GH joint injections with ultrasound guidance. In early and late follow up, the patient reported resolution of shoulder pain and it was no longer impacting sleep. This allowed her to engage in shoulder home exercise program provided by ALS interdisciplinary clinic occupational therapist with assistance from her family. Resolution of pain and impact on sleep, function, and quality of life were sustained at the 3-month visit (Supplementary Table 5).

Table 1. Pain and Impact on Sleep, Function, and Quality of Life

	Case 1	Case 2	Case 3	Case 4	Case 5
Average Pain 0-10 (R/L)
pre-injection (days from baseline)	7/7 (-19)	7/0 (-22)	3/4 (-3)	6/5 (-18)	1/7 (0)
1st follow-up (days from baseline)	4/7 (7)	2/0 (7)	0/0 (7)	1/2 (10)	0/0 (11)
2nd follow-up (days from baseline)	5/7 (28)	2/0 (21)	2/3 (25)	4/4 (31)	0/0 (28)
3rd follow-up (days from baseline)	0/0 (74)	not collected	0/0 (87)	6/6 (87)	0/0 (87)
Max Pain 0-10 (R/L)
pre-injection	9/9	9/0	4/5	8/8	1/8
1st follow-up	8/7	4/0	5/5	4/4	0/0
2nd follow-up	8/8	5/0	2/3	8/8	0/0
3rd follow-up	5/5	not collected	10/10	8/6	0/0
My shoulder pain keeps me from getting enough sleep at night.
pre-injection	Often	Sometimes	Rarely	Always	Always
1st follow-up	Never	Rarely	Rarely	Never	Never
2nd follow-up	Never	Sometimes	Never	Never	Never
3rd follow-up	Never	not collected	Never	Never	Never
My shoulder pain limits my ability to complete daily hygiene.
pre-injection	Always	Often	Always	Always	Never
1st follow-up	Often	Rarely	Always	Never	Never
2nd follow-up	Sometimes	Sometimes	Never	Never	Never
3rd follow-up	Rarely	not collected	Always	Never	Never
My shoulder pain limits my ability to get dressed each day.
pre-injection	Always	Often	Always	Always	Always
1st follow-up	Often	Sometimes	Always	Rarely	Never
2nd follow-up	Sometimes	Sometimes	Never	Rarely	Never
3rd follow-up	Always	not collected	Always	Sometimes	Never
My shoulder pain limits me from leaving the house for other activities.
pre-injection	Always	Rarely	Often	Sometimes	Never
1st follow-up	Never	Rarely	Always	Rarely	Never
2nd follow-up	Never	Sometimes	Never	Rarely	Never
3rd follow-up	Never	not collected	Rarely	Rarely	Never
My shoulder pain has a negative impact on my quality of life.
pre-injection	Always	Often	Always	Always	Never
1st follow-up	Often	Sometimes	Sometimes	Never	Never
2nd follow-up	Often	Sometimes	Never	Never	Never
3rd follow-up	Always	not collected	Always	Never	Never

In this case series, we present empiric evidence for benefit from GH joint steroid injections for PALS who present with shoulder pain in the setting of adhesive capsulitis. All study participants presented here reported improvement in their pain levels and positive impact on sleep, function, or quality of life. One of the participants (Case 5) reported complete resolution of her shoulder pain. There were no adverse events reported by the participants in this study. These results demonstrate the safety of, and suggest a role for, ultrasound-guided GH joint steroid injections for PALS with adhesive capsulitis, though additional measures may be needed for further pain management.

The development of shoulder pain from adhesive capsulitis in PALS is likely a secondary effect of their disease resulting from multiple factors such as decreased shoulder muscle strength, muscle atrophy, and reduced activity levels. The progressive lack of motion may contribute to inflammation and tightening of the joint capsule. Similar pathology has been reported in both stroke and Parkinson’s disease where there is motor dysfunction involving the shoulder.^18,19 Motion is critical to maintain and restore ROM.^13,16 For PALS with shoulder pain, stretching and range of motion exercises are recommended, and strategies to increase compliance can be helpful.²⁰ Shoulder approximation sleeves can also be used to help support the shoulder and manage pain, as well as modalities such as transcutaneous electrical nerve stimulation (TENS) devices. However, while these tools and strategies have shown promise, these interventions are not always enough to completely relieve pain or improve function.²⁰Unfortunately, there may be limited ability to complete the recommended exercises due to disease progression or pain. Often the shoulder will become quite painful and will limit ability to participate in ADLs, including daily hygiene, and may impact sleep quality and overall quality of life. When pain has become a limiting factor, the provider is challenged to make appropriate recommendations for adequate pain control and to optimize the person’s ability to participate in ADLs. This study highlights the need for multifaceted approach, which may include GH joint injections, as well as education on the cause of shoulder pain and importance of a long-term stretching program to maintain a functional ROM to minimize risk for re-freezing or ongoing pain.

Referral to musculoskeletal specialists for consideration for steroid injections should be considered for PALS with shoulder pain. The procedure offers the advantages of being a fast, safe, in-office procedure that requires no ionizing radiation or sedation. Evidence in non-ALS populations shows improved pain relief with steroid injections compared to manual therapy and exercise without injection.²¹ Shoulder injections have also been shown to be beneficial for hemiplegic shoulder pain in patients status post stroke.²²With pain relief from the injections, the person may be able to tolerate ROM and stretching exercises, which will restore motion and in turn may further improve pain, and help restore function and quality of life. Appropriate pain relief with localized steroid injections also offers a strategy to reduce reliance on pain medications with systemic medications with potential GI, renal and neurologic side effects.

It is important to minimize delays in referrals to musculoskeletal specialists given the emerging evidence of improved outcomes with earlier steroid injections in people without ALS, as well as improved efficacy compared to manual therapy with exercise.^14,21While early diagnosis and intervention is ideal, our cohort suggests that GH joint injection for adhesive capsulitis likely benefits PALS across the progression of ALS. If employed in early ALS, GH injection may allow a person to maintain ROM, functional independence, and participation in active physical therapy programs. In later-stage ALS, GH injection may offer improved passive ROM and caregiver ability to assist with ADLs, such as dressing and bathing. Throughout all ALS stages, the pain-reducing effect of GH injection may have benefits on activity, sleep and mood.

Our study is limited by the small number of participants and case series design. The ongoing COVID-19 pandemic also limited participation, such that we were not able to collect range of motion measurements as the participants completed their post injection visits over the telephone, and many did not present to clinic again during the study period due to COVID-19 restrictions. Further research is also needed to compare outcomes between those who choose not to have the injections to those who do choose this intervention. Finally, as more evidence emerges regarding specific injection techniques and steroid dose for people without ALS, it will be important to explore these same questions in the ALS population.

This case series supports the safety and efficacy of GH joint injections for adhesive capsulitis in PALS. Larger studies to determine prevalence of adhesive capsulitis versus other pathologies and to optimize comprehensive management plans aimed at complete shoulder pain resolution are needed.

PALS require a comprehensive plan to manage shoulder pain. Referrals to musculoskeletal specialists are helpful to determine the underlying cause of pain. Glenohumeral joint injections are safe and effective for adhesive capsulitis in PALS, but alone may not completely resolve shoulder pain. Additional therapies to improve ROM and reduce pain should be considered.

Ethics approval and consent to participate: Both the Mass General Brigham Institutional Review Board (IRB) and the Northwestern IRB approved this study. Eligible participants were informed of the study and study staff consented interested participants.

Consent for publication: Not Applicable

Availability of data and materials: All data generated or analyzed during this study are included in this manuscript and its supplementary information files.

Competing Interests:

Doreen Ho – reports the following disclosures: compensation for consulting from Alexion pharmaceuticals

Sabrina Paganoni – reports the following disclosures: Research grants from Amylyx Therapeutics, Revalesio Corporation, Alector Therapeutics, UCB, Biohaven Pharmaceuticals, Clene Nanomedicine, Prilenia Therapeutics, Seelos Therapeutics. Research grants from the ALS Association, the American Academy of Neurology, the CDC, ALS Finding a Cure, the Salah Foundation, the Spastic Paraplegia Foundation, the Muscular Dystrophy Association, I AM ALS, Tambourine, Target ALS, Columbia University, the Cullen Education and Research Fund. Site PI: Alector Therapeutics, Cytokinetics, Inc., Anelixis Therapeutics. Institutional consulting agreements with Amylyx Therapeutics, Frequency Therapeutics, Sola Biosciences. Personal consulting agreements with Cytokinetics, Inc., Arrowhead Pharmaceuticals, Orthogonal Neurosciences. Honoraria from Medscape

All other authors report no disclosures.

Funding: No targeted funding.

Authors’ Contributions:

Katherine M. Burke – concept and design; data collection; data analysis; drafting of manuscript; critical review of manuscript

Amy S. Ellrodt – concept and design; data collection; data analysis, critical review of manuscript

Benjamin C. Joslin – concept and design; data collection; data analysis, drafting of manuscript, critical review of manuscript

Pia P. Sanpitak - data collection; data analysis, critical review of manuscript

Claire MacAdam - data analysis and critical review of manuscript

Prabhav Deo - data collection; data analysis, critical review of manuscript

Kevin Ozment - data collection; data analysis, critical review of manuscript

Cristina Shea - data analysis and critical review of manuscript

Stephen A. Johnson - data analysis and critical review of manuscript

Doreen Ho – data analysis and critical review of manuscript

Samuel K. Chu - data collection; data analysis; critical review of manuscript

Colin K. Franz - concept and design; data collection; data analysis; drafting of manuscript; critical review of manuscript

Ashwin N. Babu- concept and design; data collection; data analysis; critical review of manuscript

Sabrina Paganoni - concept and design; data collection; data analysis; critical review of manuscript

Acknowledgements

This research would not be possible without the contributions from our patients taking the time to complete the surveys and provide feedback on the impact of the shoulder injections.

ADLs – activities of daily living

ALS – amyotrophic lateral sclerosis

ALSFRS-R – amyotrophic lateral sclerosis functional rating scale - revised

GH – glenohumeral

IRB – Institutional Review Board

NSAIDS – non-steroidal anti-inflammatory agents

PALS – people living with ALS

ROM – range of motion

TENS – transcutaneous electrical nerve stimulation

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Competing interest reported. Doreen Ho – reports the following disclosures: compensation for consulting from Alexion pharmaceuticals. Sabrina Paganoni – reports the following disclosures: Research grants from Amylyx Therapeutics, Revalesio Corporation, Alector Therapeutics, UCB, Biohaven Pharmaceuticals, Clene Nanomedicine, Prilenia Therapeutics, Seelos Therapeutics. Research grants from the ALS Association, the American Academy of Neurology, the CDC, ALS Finding a Cure, the Salah Foundation, the Spastic Paraplegia Foundation, the Muscular Dystrophy Association, I AM ALS, Tambourine, Target ALS, Columbia University, the Cullen Education and Research Fund. Site PI: Alector Therapeutics, Cytokinetics, Inc., Anelixis Therapeutics. Institutional consulting agreements with Amylyx Therapeutics, Frequency Therapeutics, Sola Biosciences. Personal consulting agreements with Cytokinetics, Inc., Arrowhead Pharmaceuticals, Orthogonal Neurosciences. Honoraria from Medscape. All other authors report no disclosures.

SupplementaryMaterial2022.08.11.docx

Ultrasound-guided glenohumeral joint injections for shoulder pain in ALS: A Case Series

Status:

Version 1

Abstract

Introduction

Methods

Results

Discussion

Conclusions

Declarations

Abbreviations

References

Additional Declarations

Supplementary Files

Status:

Version 1