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FES FOR THE PAINFUL HEMIPLEGIC SHOULDER Overview Summary of research evidence Implications for PT practice The literature review for this week is on Functional Electrical Stimulation for the Painful Hemiplegic Shoulder. Arlene Mendoza, Janet Sanabria, Telan Nelson, Amanda Lonsdale, Allison Pieracci, & Heather Nordberg

Learning Objectives By the end of the presentation the learner will be able to: Describe the incidence and etiology of hemiplegic shoulder pain (HSP). Explain the methods for preventing and treating HSP. Define Functional Electrical Stimulation (FES). Explain how FES possibly decreases HSP & increases function. Conclude whether the use of FES post-stroke to treat HSP is effective and recommended. Explain how time post stroke relates to effectiveness of FES treatment. Read this

Review of the Hemiplegic Shoulder Muscle tone change in the UE from the early to late phase of recovery: Continuum from flacidity-> hypotonicity-> normal tone-> hypertonicity-> rigidity Problems that can result from flaccidity: GH subluxation and stretching of the capsule, ligaments, muscles, and nerves Problems that can result from hypertonicity: Flexion synergy pattern in which shoulder is add and IR. Teasell, R. et al. (2008) Just to get you guys thinking about the hemiplegic shoulder since it might have been a while let go over these questions. hypotonic/flaccid to hypertonic/spastic Possible Problems that result from flaccidity-GH subluxation, stretching of capsule, ligaments, muscles, nerves Possible Problems that result from spasticity-flexion synergy pattern in which the shoulder is add, IR. Shoulder pain affect function and the individuals well-being associated with severe strokes and poorer functional outcome

Incidence of HSP In a sample of 10 studies, the incidence of HSP varied from 9-73% of hemiplegic stroke patients. The onset of HSP ranged from 2 weeks to 6 months post-stroke. There is no standardized method for determining/measuring the epidemiology of HSP. The incidence of HSP seems to increase over time following stroke. Teasell, R. et al. (2008) Bottom Line: incid/preval values among research varies greatly in terms of how may individuals will get HSP, and at what point post stroke they will develop HSP. So like many other areas of research the evidence suggests that there needs to be a standardized method for collecting incidence/prevalence data There is a huge variation in incidence (# new cases) & prevalence (#existing cases) of HSP, not all stroke patients get HSP This is just a sampling of studies that shows the variance in the time of onset of HSP after a stroke, which illustrates the difficulty in getting a true representation of the actual incidence and prevalence of HSP *There is no standardized method for determining/measuring the epidemiology of HSP 5

Etiology of HSP Multi-factorial GH subluxation Impingement Decreased ROM/Frozen Shoulder CRPS (Complex Regional Pain Syndrome) Spasticity Ada, L., & Foongchomcheay, A (2002), Chantraine, A. et al. (1999) Teasell, R. et al. (2008), Walsh, K. (2001), Vaugnat, H. et al. (2003). The cause of hemiplegic shoulder pain is multi-part and this list shows the most frequently associated impairments Research has shown that it has been associated with …... Sustained hemiplegic posture-flexor synergy pattern Spasticity in particular of the subscapularis (major internal rotator of the humerus, extension from a flexed position, and abd.) and pec major (forward flex, internally rotate, and adduct) So the take home message is that there is not one known cause of the pain.

Prevention and Treatment of HSP Acute: Prevention and Treatment: Positioning/PROM/Handling/Family education/E-stim Chronic: Treatment: Positioning Injections (steroid, Botox) Aromatherapy and acupressure Electrical stimulation TENS FES Teasell, R. et al. (2008), Walsh, K. (2001), Vaugnat, H. et al. (2003) In the acute stage prevention of HSP and the possible impairments that cause it such as GH subluxation can be done: by properly positioning the patients UE with an arm trough or a table by using and educating the family in safe handling techniques (no yanking on the arm), and this has been found to decrease the incidence of HSP from 27%-8% (Walsh) FES is used in this stage to prevent subluxation The research mentioned that HSP is treated with…… in the chronic stage

Definition of FES “FES utilizes electrical currents to activate nerves in areas of a patient’s body affected by paralysis, stroke, traumatic brain injuries, and other neurological disorders to restore some movement & function.” - Cleveland FES Center, OH http://fescenter.org/index.php?view=article&id=98:functional-electrical-stimulation-the-future-of-rehabilitation&option=com_content&Itemid=15

How Does FES Reduce HSP? Shoulder subluxation and ER One proposed mechanism of reducing HSP, however it is uncertain that shoulder subluxation is the cause of HSP. Chantraine, A. et al. (1999), Ada, L., & Foongchomcheay (2002) , Wang, RY et al. (2000), Price, C & Pandyan, A (2009), Teasell, R. et al. (2008) The literatures suggests that the proposed mechanisms for reducing HSP is decreasing shoulder subluxation, and increasing shoulder ER-which is achieved by stimulating the supraspinatus and the posterior deltoid to improve the alignment of the shoulder Shoulder subluxation may be a cause of shoulder pain; however, patients with shoulder subluxation do not necessarily experience pain and not all cases of hemiplegic shoulder pain suffer from subluxation. Although it has not been established that shoulder subluxation is the primary cause of hemiplegic shoulder pain it would still seem prudent to take care early on with the hemiplegic upper extremity to avoid subluxation.

How Does FES Reduce HSP? (continued) Other proposed mechanisms include: Stimulation of somatosensory cortex by augmented sensory feedback Increased proprioceptive stimulation Repetitive movements important for motor re-learning Increased muscle strength sNMES of cutaneous sensory nerves may modulate pain via gating pathways and central neuromodulation. Church, C. et al. (2006)

Shoulder Pain and Dysfunction in Hemiplegia: Effects of Functional Electrical Stimulation. Chantraine, A. et al. (1999) Controlled study of 24 months beginning in the first month after onset of stroke. Included CVA and Brain Injury subjects. 120 patients with a subluxed and painful hemiplegic shoulder (HSP). Patients were assigned to a control group or treatment group for a total of 5 weeks Control Group: conventional therapy (60 subjects) Treatment Group: FES and conventional therapy (60 subjects) Conventional therapy was based on the Bobath concept (NDT)

Sequence of FES Program 1st Sequence Treatment group: FES with Conventional Therapy Chantraine, A. et al. (1999) Sequence of FES Program 1st Sequence 90 min, rectangular biphasic, 8 Hz, 350 usec, 1:5, 4 channel 2nd Sequence 30 min, 40 Hz 3rd Sequence 10 min, 1 Hz Subjects in the treatment group received an FES program was comprised of three sequences. They used the Medico-Complex machine. The sequence program was performed daily. In the 2nd and 3rd weeks, the first and second sequences each lasted 5 minutes longer. In the 4th and 5th weeks the same sequences were again increased 5 minutes longer.

Reduction in PAIN Treatment group vs. Control group Chantraine, A Reduction in PAIN Treatment group vs. Control group Chantraine, A. et al. (1999)   FES Control p value Time % pain reduction 3 mo 70.2 36.2 p<.001 6 mo 77.2 48.6 p<.01 12 mo 80.7 55.2 p<.02 24 mo p<.03 “Each patient’s shoulder was examined by observation, palpation, and assessment of range of motion. The physician recorded pain present or absent at rest and during passive and active range of motion of the shoulder. In addition, pain was evaluated using the visual analog scale. These four variables of pain score were performed at 6, 12, and 24 months. To get no pain, the four variables had to be negative.” (pg. 329) At 3months after stroke, the treatment group improved in pain by 70.2% compared to the control group, at 6 months treatment group improved by 77.2% compared to 48.6%, at 12 months..etc.

Improvement in Subluxation Grades Treatment group vs Improvement in Subluxation Grades Treatment group vs. Control group Chantraine, A. et al. (1999) de Bats Subluxation Scale Grade 1: Widening of the GH joint line or outward gliding of humeral head. No rupture of the scapulohumeral girdle. Grade 2: Evidence of the beginning of scapulohumeral girdle rupture. Grade 3: The scapulohumeral girdle rupture is complete. The joint is somewhat impaired.   FES Control p value Time % Improvement of subluxation grade 6 mo 73.7 39.7 p<.001 12 mo 78.9 58.6 p<.05 24 mo Chantraine, A. et al. used the de bats Subluxation Scale (read chart). “This classification assesses anteroposterior radiographs centered at the glenohumeral joint to distinguish different radiologic grades.” (pg. 329). Radiologic evidence of subluxation was confirmed by a radiologist. Most of the subjects had a de Bats grade of subluxation of a grade II and III. X-rays were taken between third and six weeks after stroke, and then at 6, 12, and 24 months. Reduction of of subluxation was considered positive when the shoulder reached to its normal position or a grade I on the de Bats subluxation scale. (Read chart)

Improvement in Recovery of Motor Function Treatment group vs Improvement in Recovery of Motor Function Treatment group vs. Control group Chantraine, A. et al. (1999)   FES Control p value Time % Recovery of Motor Function 6 mo 77.2 46.6 p<.001 12 mo 82.5 60.3 p<.01 24 mo Patients were asked to perform an antepulsion and abduction of their hemiplegic arm in sitting position to fix the trunk and avoid compensation. Recovery was positive when patients were able to abduct their hemiplegic arm to 40 degrees and antepulsion of 60 degrees. FES speeds up motor recovery.

Results Chantraine, A. et al. (1999) At all measurement stages the FES group had statistically significant improvements in subluxation, pain, and ROM as compared to the control group. Maintained for at least 24 mo’s. Treatment group: Maximum improvement in pain, subluxation, and motor recovery was observed at 6 months. Control group: Slow & progressive improvement reaching a max improvement after 1 yr. Overall: Two thirds of the cases improved in pain, subluxation, and remained constant up to 24 months. Chantraine et al mentioned that the benefits of recovery was maintained for a long time because it was “…perhaps due to continued exercise.” Chantraine et al referred to a Wanklyn et al study that suggested that there was an increase in shoulder pain in the first week after discharge in patients who did not continue to exercise adequately” However, significant reduction of subluxation in the treatment group, indicates that FES is an effective method for early treatment. Although there was an improvement in the control group over time, their study suggest that functional improvement of the HSP treated with FES is significant to decrease disability rates related to neurologic deficits.

Conclusion Chantraine, A. et al. (1999) FES appears to decrease pain, subluxation, improve ROM, and increase motor function and therefore directly influences the degree and rate of recovery.

Intramuscular Electrical Stimulation for Hemiplegic Shoulder Pain Yu DT, Chae, J. et al (2004) Subjects: 61 Treatment Group: 32 (intramuscular NMES) Control Group: 29 (Cuff-type sling) Inclusion criteria: >12 weeks post-stroke Pain rating >2 on the 11 pt. NRS 1/2 fingerbreadth of inferior glenohumeral subluxation

Study Parameters Treatment Group: Yu DT, Chae, J. et al (2004) Treatment Group: Intramuscular stimulation 6 hours/day for 6 weeks 20 sec on time/10 sec off time 20 mA and 10 - 200㎲ Intramuscular electrodes placed in the supraspinatus, posterior deltoid, middle deltoid, and upper trapezius. The electrodes were placed in the clinic and left in for the duration of the study. Control Group: Cuff-type hemisling for 6 weeks

Outcome Measures Primary Outcome Measures: Yu DT, Chae, J. et al (2004) Primary Outcome Measures: BPI 12--A pain questionnaire that assesses pain intensity (0-10) scale as well as interference of pain in daily activites. Secondary Outcome Measures: BPI question 23 Subluxation (assessed radiographically) Pain- free passive ER ROM Hemiparetic upper limb strength and coordination measured through the Fugl-Meyer motor assessment Spasticity assessed with Ashworth scale Upper limb-related activity limitation assessed by FIM instrument and Arm Motor Ability Test

Results: Pain improvement Early group vs. Late group Chae, J Results: Pain improvement Early group vs. Late group Chae, J. et al (2007) Percent of treatment successes based on the 30% success criterion. ES = electrical stimulation. *P = .001. **P < .001. Percent of treatment successes based on the 2- point success criterion. ES = electrical stimulation. *P = .001. **P < .001.

Results: Early Group vs Results: Early Group vs. Late Group Mean change in BPI 12 scores Chae, J. et al (2007) Early group (<77 weeks post stroke) ES (n=16) Control (n=14) EOT 5.5 0.9 3 months 6.5 0.21 6 months 6.6 1.2 12 months 6.8 2.4 Late group (>77 weeks post stroke) Table 5 shows the results of the post hoc comparisons of change in BPI 12 scores at each posttreatment assessment for the early group. The ES group exhibited significantly greater reduction in BPI 12 scores at all posttreatment assessments. Table 6 shows the results of the post hoc comparisons of change in BPI 12 scores at each posttreatment assessment for the late group. The ES group exhibited greater reduction in BPI 12 scores at EOT compared to controls, although the difference did not reach statistical significance. ES (n=16) Control (n=15) EOT 3.6 0.9 3 months 2.4 1.1 6 months 2.3 1.5 12 months 3.2

Results: Treatment Group vs. Control Group Chae, J. et al (2007) At end of treatment (EOT), 84% of the ES group experienced a ≥2 pain scale reduction compared to 31% of the control group. At 12 months, 78% of the ES group experienced a ≥2 pain scale reduction compared to 52% of the control group. A significantly higher success rate was seen for the ES group compared to the control group at EOT but not at 3, 6, and 12 months. There was no significant difference in any of the secondary outcomes measured. Looking at intramuscular because: Surface electrical stimulation (ES) has been shown to reduce shoulder subluxation and improve pain-free range of motion (ROM).2 However, despite demonstrated benefits, surface ES has not been adopted by the clinical community due to pain of stimulation, need for skilled personnel to ensure reliable stimulation, and lack of third-party payer reimbursement. To address the limitations of surface ES, a novel percutaneously placed intramuscular ES system was developed. Preliminary studies demonstrated that intramuscular ES is well tolerated, may be effective in reducing shoulder pain, is reliable in producing muscle contraction, and is easily managed in the home by the user or caregiver without skilled personnel.3-6 Subjects were at least >12 wks post stroke RCT: 61 total 32 FES and 29 control (no treatment but were given a hemisling for the 6 weeks) 6 hrs e-stim for 6 wks Brief Pain Inventory Question12: a successful outcome was measured as a 2 pt decrease in BPI 12 score or with a 30% reduction in score 23

Conclusion Chae, J. et al (2007) FES can be beneficial for HSP if treated early (<77 weeks), and effects can be seen up to 12 months after treatment. Late treatment (>77 weeks) showed no significant improvements and any effects are only seen short-term. The treatment group had a higher success rate at EOT, but there was no significant difference between the treatment group and the control group at all of the follow-up measurements.

RCT to Evaluate the Effect of sNMES to the Shoulder After Acute Stroke Church, C. et al. (2006) 176 Stroke patients, within 10 days post stroke Treatment Group: (90 patients) surface neuromuscular electric stimulation (sNMES) and stroke unit rehab One electrode over supraspinatus and one over posterior deltoid 30 Hz; 15sec on/ 15sec off (3 sec ramp) Increase intensity until visible contraction Treated 1hr, 3x/day for 1 month Control Group: (86 patients) “sham” sNMES and stroke unit rehab RCT-largest done to date in 2006 Inclusion criteria: No previous UE injury, cognitive or language impairment that would influence assessment, another dx that would interfere with rehab, contraindication for sNMES Treatment Group vs Control Parameters The control group received the identical treatment and set-up -----internal disconnect in the machine that prevented any current from flowing into the patient. 25

Outcome Measures Church et al. (2006) Primary (at 3 months): Action Research Arm Test (ARAT) Secondary (at 4 weeks and at 3 months): Motricity Index Frenchay Arm Test 0-10 Numerical Pain Rating Scale (UE) 5-point adjectival scale (UE pain) Star Cancellation (for cortical function) Participants’ views regarding the sNMES Global health status at 3 months (Nottingham Health Profile and Oxford Handicap Scale) Primary: ARAT is a functional test that----Grasp, Grip, Pinch, Gross Movement Secondary: Included other upper limb function and impairment tests including pain rating

Results Church et al. (2006) Results at 4 weeks: There were no significant differences in any of the outcome measures between the control group and the treatment group. Results at 3 months: There were no statistically significant differences in: Arm function (ARAT total) Upper limb pain Star Cancellation Global health status Results at 4 weeks: There was no significant difference in any of the outcome measures between the control group and the treatment group. Results at 3 months: There were no statistically significant differences in Arm function (ARAT total) Upper limb pain Star Cancellation Global health status But a number of secondary outcomes (upper limb impairments, other measures of arm function) were unexpectedly better in the control group 3 months after stroke.

Is sNMES hazardous for stroke patients with severe upper limb impairment? Church et al. (2006) Some upper limb function at baseline ARAT>0 No upper limb function at baseline ARAT=0 Treatment vs. Control 4 weeks No Significant Difference 3 months Significant Difference in Favor of Control Group In order to try to explain why the control group as a total scored better at 3 months on some of the secondary measures, the authors analyzed the data by breaking the control group and the treatment group into two subgroups: those with some initial arm function and those without any initial arm function according to their ARAT score. The subgroups compared the patients who had no upper limb function at the start of the trial with those who had some upper limb function. At three months, the study reveals that adding sNMES to the stroke rehab program in patients with severely impaired UE may actually hinder functional recovery of the hemiplegic UE. There was a statistically significant difference in the grasp and gross subsections of the ARAT and Frenchay Arm Test and the arm portion of the Motricity Index in favor of the control group. 28

Many hypotheses why poor outcome with severely impaired UE Church et al. (2006) Abnormal afferent stimulation causes maladaptive plasticity. Early over-use of the affected arm Unable to report adverse events or wrong delivery Overstimulation leading to shoulder subluxation May have promoted learned non-use of this arm. sNMES produces abnormal afferent stimulation. It is possible that artificial stimulation proximally interferes with later distal recovery through maladaptive plasticity. 2. FES may have resulted in early over-use of the affected arm. 3. Those with severe impairment may have been less aware of the stimulation; therefore, less likely to report adverse events or wrong delivery. 4. Overstimulation may have produced tiredness and shoulder subluxation. 5. Participants may have used their affected arm less while sNMES was being given; may have promoted learned non-use of this arm.

Conclusion Church et al. (2006) For typical stroke patients treated in stroke rehab units: sNMES does NOT improve upper limb function, nor decrease pain after acute stroke. Routine use of sNMES CANNOT be recommended as it can pose potential negative consequences in those with initial severe impairment. Further research is needed to determine if there is a benefit to using sNMES for specific patient populations.

The Evidence-Based Review of Stroke Rehabilitation Teasell, R. et al Canadian Systematic Review Over 15 Studies included There is conflicting evidence that FES reduces pain, improves function and reduces subluxation after stroke. FES may not help with recovery of hemiplegic shoulder. www.ebrsr.com The Evidence-Based Review of Stroke Rehabilitation (EBRSR) which is conducted by an organization based out of Canada that reviews current practices in stroke rehabilitation. Their methods of rating evidence are different, but the organization has a systematic approach just as Cochrane. 0ver 100 studies that look at treatments for HSP In their most recent,11th publication on  they they concluded….. There is conflicting evidence that functional electrical stimulation reduces pain, improves function and reduces subluxation following stroke. (The SREBR was designed to be an up-to-date review of the current evidence in stroke rehabilitation, related to the effectiveness of both pharmacological and non-pharmacological interventions. Just like Cochrane they have a literature search strategy, data abstraction process, and a method for scoring the quality of individual studies and the process that was used to formulate the levels of evidence which form the basis of the review). 31

Implications for PT Standardization is needed in reporting HSP Inconclusive if FES reduces HSP Inconclusive if FES improves function FES may be beneficial for treating GH subluxation Earlier initiation of FES treatment may result in a better outcome

Review Learning Objectives Describe the incidence and etiology of hemiplegic shoulder pain (HSP). Explain the methods for preventing and treating HSP. Define Functional Electrical Stimulation (FES). Explain how FES possibly decreases HSP & increases function. Conclude whether the use of FES post-stroke to treat HSP is effective and recommended. Explain how time post stroke relates to effectiveness of FES treatment.

REFERENCES Ada, L., & Foongchomcheay, A. (2002). Efficacy of electrical stimulation in preventing or reducing subluxation of the shoulder after stroke: A meta-analysis. Australian Journal of Physiotherapy, 48: 257- 267. Chantraine, A., Baribault, A., Uebelhart, D., & Gremion, G. (1999). Shoulder pain and dysfunction in hemiplegia: Effects of functional electrical stimulation. Archives of Physical Medicine and Rehabilitation, 80: 328-331. Chae J et al. Intramuscular Electrical Stimulation for Hemiplegic Shoulder Pain: a 12 month follow up of a multiple center, randomized clinical trial. Am J Phys Med Rehabil. 2005;84:832-842. Church, C., Price, C., Pandyan, AD., Huntley, S., Curless, R., Rodgers, H. (2006). Randomized controlled trial to evaluate the effect of surface neuromuscular electrical stimulation to the shoulder after acute stroke. Stroke, 37: 2995–3001.

REFERENCES Price, CIM., & Pandyan, AD. (2009). Electrical stimulation for preventing and treating post-stroke shoulder pain. Cochrane Database of Systematic Reviews 2009 (1). Scott, Tom. "Functional Electrical Stimulation: The Future of Rehabilitation." Cleveland FES Center. United Spinal’s Action Online Magazine, 17 Nov. 2008. Web. 24 Apr. 2010. <http://fescenter.org/index.php?view=article&id=98:functional- electrical-stimulation-the-future-of- rehabilitation&option=com_content&Itemid=15> Teasell, R., Foley, N., Bhogal, S. (2008). Version 11: Painful hemiplegic shoulder. Obtained from the WWW April 7, 2009 at http://www.ebrsr.com/reviews_details.php?16 Vaugnat, H. & Chantraine, A. (2003). Shoulder pain in hemiplegia revisited:Contribution of functional electrical stimulation and other therapies. Journal of Rehabilitative Medicine, 35: 49-56.

REFERENCES Wang, RY., Chan, RC., & Tsai, MW.  (2000).  Functional electrical stimulation on chronic and acute hemiplegic shoulder subluxation.  American Journal of Physical Medicine and Rehabilitation, 79 (4): 385-390. Walsh, K. (2001). Management of shoulder pain in patients with stroke. Postgraduate Medical Journal, 77: 645-649. Yu DT, Chae J, Walker ME, et al. Intramuscular neuromuscular electrical stimulation for post-stroke shoulder pain: a multi-center randomized clinical trial. Arch Phys Med Rehabil. 2004;85:695-704.