Multiple Sclerosis and Spasticity

Multiple Sclerosis and Spasticity

Our case

Study: Early physiotherapy after injection of botulinum toxin type A

Design an evidence-informed intervention to manage spasticity in a patient with a CNS lesion: stroke, SCI or MS

Literature search- Medline

PICO Question

What is MS?

P - Patients with MS

I - Spasticity management interventions

C - No spasticity management interventions

O - Improvement in function

In patients with MS, does application of spasticity management interventions result in improvement in function compared to no such intervention?

• 34 randomized controlled trials
• 6 systematic reviews

Literature search- PEDro

Levin M

• Type of study
• Methods
• Treatment group
• Control group
• Main measures taken
• Modified Ashworth scale (MAS)
• Visual Analogue Scale (VAS)
• Expanded Disability Status Scale (EDSS)

Goals of Intervention

simple search: multiple sclerosis spasticity

• 20 randomized controlled trials
• 3 systematic reviews

Exercise and MS

• Achieving individualized, patient-centred goals
• Collaborate with patient, care-giver and rehabilitation team
• Reduce symptoms or impairments, improve activity level, participation, quality of life

Amatya B, Khan F, La Mantia L, Demetrios M, Wade DT

• Chronic inflammatory disease of the brain, spinal cord and optic nerve
• Primary cause of nontraumatic disability
• Lesions and plaques

Effect of acute unloaded arm versus leg cycling exercise on the soleus H-reflex in adults with multiple sclerosis

Limitation of the study

Symptom management

Sensory impairments

• It is key!
• Goal: maintain full ROM of soft tissue
• Meaningful daily living
• Identify concerns of patient to guide the treatment program
• Modalities

• Visual system: optic neuritis
• Somatosensory disturbances
• Vestibular system

Study: RCT

Measures of spasticity:

Hoffman’s reflex (H-reflex) Soleus Muscle.

Tibial Nerve – Monopolar Electrical stimulation of Ia afferent fibers of muscle spindles and measure was taken with bipolar + EMG (H and M waves)

Modified Ashworth Scale

Motor impairments

Theory

• Small sample size
• No functional outcome measures
• ROM
• Spasm Frequency scale
• Joint resting angles
• MAS
• Subjective evaluation
• VAS
• Depends on psychological burden of patient at the time of assessment
• CASP
• 10/11

• Weakness, ataxia, tremor
• Spasticity: 'heaviness of limbs', 'jumping of the limbs', 'involuntary, painful movements'
• Higher prevalence in women and longer duration of disease
• Correlated with patient-reported disability and poor quality of life

• Improves diffusion of botox in injected muscle
• Decreases muscle contracture
• Promote functional recovery
• Re-education on the altered spastic muscle
• Positive effect on mood
• Delayed VAS

Results

Critical appraisal: 9/11 (CASP)

Clinical messages

Critical appraisal of Results (CASP): 9/11

1. Did the trial address a clearly focused issue? Yes

2. Was the assignment of patients to treatments randomized? Yes

3. Were all of the patients who entered the trial properly accounted for at its conclusion? Yes

*4. Were patients, health workers and study personnel ‘blind’ to treatment? No … but it is very difficult to “blind” someone on exercise training

5. Were the groups similar at the start of the trial? Yes

6. Aside from the experimental intervention, were the groups treated equally? Yes

*7. How large was the treatment effect? Moderate to large (Cohen’s d)

*-8. How precise was the estimate of the treatment effect? Confidence interval not mentioned

9. Can the results be applied to the local population? Yes

*-10. Were all clinically important outcomes considered? No … could have had more measures

11. Are the benefits worth the harms and costs? Yes

- Both Arm and Leg Cycling work to decrease lower limb spasticity

- Acute unloaded arm cycling on spasticity in MS provides another tool to target lower limb spasticity in this population.

- The benefit would be dramatic for persons with severe spasticity of the legs that interferes with the capacity to undertake lower leg exercise.

• EDSS
• No difference in both groups
• MAS
• Decrease in both groups after injection
• Difference in both groups
• VAS
• Detected an improvement in spasticity after 4 weeks

- Statistically significant improvement in MAS scores and soleus Hreflex for Both Leg and Arm cycling.

Arm (d’s =−0.80 and −0.51) Moderate to large

Leg (d’s =−1.11 and −1.21) Large

Evaluation of a single session

with cooling garment for persons with

multiple sclerosis: a randomized trial

Group exercise training for balance, functional status, spasticity, fatigue and quality of life in multiple sclerosis: a randomized controlled trial

• Study: RCT - A crossover study with randomized assignment,
• PEDro score: 7/10
• Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes
• Participants: 43 heat-sensitive persons with MS
• Intervention: Subjects wore the cooling garment over a thin cotton T-shirt for 45 min while sitting quietly; the garment had either been cooled in a freezer (at -20 C) or was presented at approximately 22 C.

Pilot Study: FES cycling reduces spastic muscle tone in a patient with multiple sclerosis

The effects of TENS on Spasticity in Multiple Sclerosis

Study: RCT

Exercise training group = 3x week, 12 weeks

Control group = No intervention (they were told they were on the waiting list for treatment)

Intervention:

The programme included

- flexibility

- range of motion

- strengthening with/without Theraband for LE

- core stabilization

- balance and coordination exercises

- functional activities.

Type of study: RCT

Type of Study - Reported Case

• Pt given 2 sessions of FES (functional cycling movement) on 3 muscle groups of each leg

Subjective Measures

Conclusion - statistically significant improvement in the intervention group

• Objective (timed gait, stride length, basic mobility and standing balance)
• Subjective (fatigue, spasticity, weakness, balance, gait, transfers, ability to think clearly and recovery time)

Regarding spasticity, there was a discrepancy between the objective and subjective results

The MAS may not fully capture spasticity in active movements, in which persons are more likely to benefit from even small reductions in spasticity. A reduction of 0.5 points on the MAS was found with active treatment, although this was not statistically significant. The subjects’ ratings of subjectively reduced spasticity were certainly related to how the spasticity interacted with voluntary movements and activities, i.e., at the level of activity and participation.

The Rehband vest contains coolant-filled bags that can be either cooled in a freezer or heated. The vest can be worn at work, while travelling or exercising, and during other daily activities,

roguefitness.com

Objective Measures

Spasticity measures taken:

-Global spasticty scale (Ashworth, Clonus, Patellar tendon reflex)

Muscle spasm and pain measures

-10 point VAS

-Penn spasm scale

Measurement Scales - Modified Ashworth Scale (MAS) + Semiautomated Pendulum Test (PT)

• Measurements taken before and after session (10 trials per session)

Mechanism of Action - FES can lead to reduction of spasticity via contraction of paretic muscle -> reciprocal inhibition of spastic antagonist

Treatment options

Critical Appraisal: 10/11 (CASP)

Results

1. Did the trial address a clearly focused issue? Yes

2. Was the assignment of patients to treatments randomized? Yes

*3. Were all of the patients who entered the trial properly accounted for at its conclusion? No, but explained why some where excluded

*4. Were patients, health workers and study personnel ‘blind’ to treatment? No … but obviously you can’t blind someone who receives treatment vs someone who receives nothing

5. Were the groups similar at the start of the trial? Yes

6. Aside from the experimental intervention, were the groups treated equally? Yes

*7. How large was the treatment effect? Pearson r (correlation) … L H flex MAS = 0.3 Moderate. All other values > 0.5 so Large

*-8. How precise was the estimate of the treatment effect? Confidence interval not given

9. Can the results be applied to the local population? Yes

10. Were all clinically important outcomes considered? Yes, Spasticity + functional

11. Are the benefits worth the harms and costs? Yes

Results

No sig difference between Groups Initially

The primary outcome measures:

- Berg Balance Scale,

- 10-metre walk test,

- 10-steps climbing test

Secondary outcome measures:

- Modified Ashworth Scale,

- Tonus of hip flexors, hamstring and Achilles tendon,

- Fatigue Severity Scale

- Multiple Sclerosis International Quality of Life.

Methods and Experiment

Clinical messages

Figure 3 Mean and standard deviation of the Visual

Analogue Scale (VAS) used to measure pain before and

after two weeks of 60 minutes (left) and 8 hours (right) per

day of transcutaneous nerve stimulation (TENS).

• Attending a group exercise programme leads to significant improvements in bal­ance, functional status and also in fatigue.

• Without exercise training, initial status was not maintained, even over 12 weeks, in patients with multiple sclerosis.

• Group exercise training is a feasible choice in multiple sclerosis management.

-32 subjects with controlled MS between ages of 30-67 y.o

-Atleast 1 spastic LE limb

-No previous TENS treatment

-Short vs long duration TENS application

-2 weeks app, 2 weeks none, 2 weeks alternative

-Frequency:100Hz pulse width:0.125ms Continuous

-"strong but comfortable sensation"

Results

Critical appraisal (CASP): 10/11

Critical Appraisal

Post-FES session

• Increased peak velocity of first flexion swing phase
• Increased relaxation index
• Improved MAS score

Figure 2 Mean and standard deviation of the Penn Spasm

Scores (PSS) before and after two weeks of 60 minutes (left)

and 8 hours (right) per day of transcutaneous nerve

stimulation (TENS).

Results

9/11 CASP

Discussion

1. Did the trial address a clearly focused issue? Yes

2. Was the assignment of patients to treatments randomized? No, there was only one patient so there was no control group

3. Were all of the patients who entered the trial properly accounted for at its conclusion? Yes

4. Could the result of the test be influenced by the reference standard? No for patient, yes for evaluator, single blind experiment

*5. Were the groups similar at the start of the trial? Yes, they were the same patient

6. Aside from the experimental intervention, were the groups treated equally? Yes, but the patient received were tested before and after treatment

7. How large was the treatment effect? Large for MAS, relaxation index and peak velocity (Cohen’s d)

8. How precise was the estimate of the treatment effect? Confidence interval not mentioned

*9. Can the results be applied to the local population? Unknown, this is an isolated case, but can definitely be applied to the patient at hand

10. Were all clinically important outcomes considered? Yes and no, more clinical and physiological measures can be used (ie. clonus, functional scale, or H reflex)

11. Are the benefits worth the harms and costs? Yes, FES is an cost-effective treatment in general

CONCLUSION: CASP "7/11"

-GSS not significantly different

-25% subjects showed 2+ point in 8hr TENS

-PSS

-Significant reduction in long app

-small not significant in short app

-VAS

-significant reduction in long app

-small not significant in short app

-TENS no significant effect on lower limb spasticity in MS

-Longer TENS application leads to decrease pain and spasm

-Subjects felt TENS reduced symptoms

-87.5% for spasm

-73.3% for pain

-73.3% for stiffness

Conclusion

Results

-No control group

-TENS application site

-Different muscle groups tested

PRO: Good cost-effective method to reduces spasticity, good results from clinical measurements

CONS: However lack of evidence and insufficient experimental data argues against the use of FES as the BEST modality.

• May be a good modality to use for some patients as every case of MS induced spasticity is individualized, however no general conclusions can be drawn for the effectiveness for reduction of spasticity for all populations with MS

Post-FES session

• Induced additional swings in PT
• Increase sinusoidal waveform
• Increased stretching at start position
• Greater swing range

Fig 1. 4 swing tests for L leg during 2 separate sessions

1. Botox- effective but out of scope of practice

2. Exercise- effective and simple to prescribe

3. Cooling vest- effective in combination

4. TENS- decrease in pain and spasm

Conclusion and treatment pan

• Treatment goal: Increase function and quality of life
• Exercise (functional ex, flexibility training, etc)
• Gentle stretching
• Prevent joint contractures and muscle stiffness
• TENS
• Inexpensive, portable, effective
• Cooling modalities
• objective and subjective impact