Neurostimulation Devices for Frozen Shoulder

Overseen By Louis-David Beaulieu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Chicoutimi

Disqualifiers: Cognitive disorders, Neurological disease, Muscle tear, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to compare the integrity of somatosensory processing with transcranial magnetique stimulation (TMS) and corticospinal excitability of the affected shoulder in individuals with adhesive capsulitis versus healthy controls. The secondary objective is to compare the clinical and neurophysiological effects of an intervention using tendon vibration (VIB) to induced kinesthetic illusions. This will involve comparing two groups: one receiving a real intervention versus a placebo intervention protocol, both coupled with standardized exercises in individuals with capsulitis. The hypotheses are that the proprioceptive processing and corticospinal excitability are impaired in the presence of capsulitis, and that the VIB + exercises intervention will result in greater improvements than the placebo VIB + exercises. To goal is to establish the first empirical foundations for understanding adhesive capsulitis, using cutting-edge neurophysiological investigation technologies. TMS will be used to explore the presence of maladaptive plasticity in motor networks by assessing the excitability and integrity of the primary motor cortex (M1) and the corticospinal tract. Recruitement: 30 healthy participants and 30 participants with a diagnosis of adhesive capsulitis will undergo 2 baselines assesments, 6 interventions with tendon vibration and 2 follow-up evaluation. Participants will be age- and sex-matched. Baseline and follw-up include: * Questionnaires : SPADI, QuickDASH, French version of the Mcgill Pain Questionnaire; * Active and passive range of motion; * Ultrasound for diagnosing capsulitis. Comparison parameters: * active motor threshold (aMT) * Motor evoked potential (MEP) latency and amplitude * Standardized kinesthetic illusion procedure (SKIP) : direction of illusion, clearness, amplitude/speed. Interventions : * 2 baselines including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP; * 2 VIB interventions per week, for 3 weeks * Real VIB : 80Hz of vibration to induce kinesthetic illusions, * Placebo VIB : 40Hz of vibration that does not induce kinesthetic illusions * 2 follow-up including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is neurostimulation, like tendon vibration, safe for humans?

Tendon vibration has been studied for its effects on muscle activity and brain response, but specific safety data for its use in humans is not detailed in the available research. However, it is generally considered safe when used in controlled settings for rehabilitation purposes. ^{1 2 3 4 5}

How does the treatment Tendon Vibration differ from other treatments for frozen shoulder?

Tendon Vibration is unique because it uses vibratory stimulation to recruit motor units in muscles, which can help in muscle reeducation and improve movement control. This approach is different from traditional treatments that may focus on physical therapy or medication, as it directly targets the neuromuscular system to enhance motor function. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for individuals with adhesive capsulitis, also known as frozen shoulder. It seeks 30 people with this condition and 30 healthy participants to compare treatments. Participants must be age- and sex-matched to join the study.

Inclusion Criteria

I have been diagnosed with frozen shoulder.

Good general health

I do not have shoulder pain.

Exclusion Criteria

I have had shoulder surgery or have a shoulder prosthesis.

Pregnant woman

Presence of metal in the skull or jaw

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including questionnaires, ultrasound, active and passive range of motion, TMS procedure, and SKIP

1-2 weeks

2 visits (in-person)

Treatment

Participants receive 6 interventions with tendon vibration, 2 per week for 3 weeks, accompanied by a daily exercise protocol

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaires, ultrasound, active and passive range of motion, TMS procedure, and SKIP

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Tendon Vibration

Trial Overview The study tests how tendon vibration therapy combined with exercises affects somatosensory processing in those with frozen shoulder versus a placebo group. The effectiveness of these interventions will be measured using neurophysiological assessments like TMS.

Participant Groups

Group I: Tendon vibration and standardized exercise protocol Experimental Treatment 2 Interventions

Six interventions inducing kinesthetic illusions (20 minutes, 1 illusion/minute). Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.

Group II: Tendon vibration without kinesthetic illusion and standardized exercise protocol Placebo Group 2 Interventions

Six interventions not inducing kinesthetic illusions (20 minutes) Two interventions per week, for three weeks. Accompanied by a daily exercise protocol.

Who Is Running the Clinical Trial?

Université du Québec à Chicoutimi

Lead Sponsor

Trials

7

Recruited

320+

Findings from Research

Electrophysical agents like extracorporeal shockwave therapy (ESWT) and laser therapy showed some potential benefits in reducing pain and disability in frozen shoulder patients, but the evidence is uncertain due to high risk of bias and study variability.

Ultrasound therapy did not demonstrate any significant improvements in outcomes for frozen shoulder, and overall, the low quality of evidence means that these treatments cannot be recommended confidently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of electrophysical agents in subjects with frozen shoulder: a systematic review and meta-analysis. Brindisino, F., Girardi, G., Crestani, M., et al.[2023]

Combining tendon vibration with high-frequency repetitive transcranial magnetic stimulation (rTMS) can enhance the cortical aftereffect, leading to increased excitability in the vibrated muscle (flexor carpi radialis) and decreased excitability in its antagonist (extensor carpi radialis).

This method resulted in a lasting effect on motor cortex excitability, persisting for up to 30 minutes, suggesting potential applications in rehabilitation for correcting muscle imbalances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boosting and consolidating the proprioceptive cortical aftereffect by combining tendon vibration and repetitive TMS over primary motor cortex. Perasso, L., Avanzino, L., Lagravinese, G., et al.[2020]

A 10-week CNS-focused treatment program for frozen shoulder (FS) showed significant improvements in self-reported shoulder pain and active shoulder flexion, indicating its potential efficacy in reducing pain and disability associated with FS.

70% of participants completed the treatment, and while some measures showed improvement, further research is necessary to confirm these findings and better understand the treatment's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Central Nervous System Focused Treatment Program for People with Frozen Shoulder: A Feasibility Study. Mena-Del Horno, S., Dueñas, L., Lluch, E., et al.[2023]

Glenohumeral intra-articular corticosteroid injections provide significant short-term relief for frozen shoulder, showing greater benefits within 4 to 6 weeks compared to other nonoperative treatments like exercise and joint mobilization.

A new classification system based on patient irritability levels can guide rehabilitation interventions, ensuring that treatment strategies are tailored to individual patient needs for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frozen shoulder: evidence and a proposed model guiding rehabilitation. Kelley, MJ., McClure, PW., Leggin, BG.[2022]

Noxipoint therapy (NT) significantly reduced chronic neck and shoulder pain by 89.6%, improved function by 77.4%, and enhanced quality of life by 88.1% in a study of 97 patients over a follow-up period of 4 weeks to 5 months, outperforming conventional physical therapy (PT-TENS).

The efficacy of NT was further supported by a rat study, which showed a similar reduction in chronic hypersensitivity, indicating that NT's benefits may be generalizable beyond human subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Noxipoint Therapy versus Conventional Physical Therapy for Chronic Neck and Shoulder Pain: Multicentre Randomised Controlled Trials. Koo, CC., Lin, RS., Wang, TG., et al.[2022]

In a study involving 17 participants, vibratory stimulation and maximal isometric contraction significantly hindered the ability to isolate a specific motor unit in the extensor carpi radialis brevis muscle, indicating that these stimuli can disrupt fine motor control.

The findings suggest that the increased recruitment of motor units due to vibration or contraction may interfere with the necessary inhibitory mechanisms for isolating a single motor unit, leading to potential therapeutic applications for muscle reeducation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration influence on control of single motor unit activity. Malouin, F., Simard, T.[2009]

A new device using functional vibratory stimulation (FVS) improved shoulder flexion in a patient with hemiparesis due to thalamic bleeding, allowing him to manipulate objects with his hand after 1 month of treatment.

Despite the observed improvements in shoulder and finger function, FVS did not increase the excitability of the motor cortex or spinal motor neurons, suggesting that the mechanism of action may not involve these pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional vibratory stimulation on the hand facilitates voluntary movements of a hemiplegic upper limb in a patient with stroke. Shirahashi, I., Matsumoto, S., Shimodozono, M., et al.[2016]

In a study involving 27 subjects with moderate Parkinson's Disease, muscle vibration (MV) was found to significantly influence resting tremor, with tremors stopping or starting in sync with the onset and offset of the vibration.

While tremors continued during MV, their frequency patterns changed, suggesting that MV may affect both spinal and brain-level mechanisms involved in tremor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibratory proprioceptive stimulation affects Parkinsonian tremor. Jöbges, EM., Elek, J., Rollnik, JD., et al.[2019]

A new non-invasive treatment called vibrotactile coordinated reset (vCR) aims to improve motor and non-motor symptoms in Parkinson's disease (PD) patients by delivering gentle vibrations to the fingertips, with a 7-month study involving 30 participants to assess its efficacy.

The study will measure the effects of vCR on motor abilities using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other evaluations, with the goal of providing evidence for FDA clearance of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Pfeifer, KJ., Cook, AJ., Yankulova, JK., et al.[2023]

Upper limb vibration (ULV) during exercise significantly reduces spinal reflex activity, as evidenced by a 15.7% decrease in H-reflex amplitude and a 20% reduction in cutaneous reflexes, indicating enhanced presynaptic inhibition of afferent transmission.

Despite these changes in spinal reflexes, ULV does not affect corticospinal excitability, suggesting that while ULV may help improve rehabilitation outcomes for conditions like spasticity, it does not alter the overall excitability of the motor pathways controlling the forearm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect Vibration of the Upper Limbs Alters Transmission Along Spinal but Not Corticospinal Pathways. Barss, TS., Collins, DF., Miller, D., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of electrophysical agents in subjects with frozen shoulder: a systematic review and meta-analysis. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Boosting and consolidating the proprioceptive cortical aftereffect by combining tendon vibration and repetitive TMS over primary motor cortex. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Central Nervous System Focused Treatment Program for People with Frozen Shoulder: A Feasibility Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Frozen shoulder: evidence and a proposed model guiding rehabilitation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Novel Noxipoint Therapy versus Conventional Physical Therapy for Chronic Neck and Shoulder Pain: Multicentre Randomised Controlled Trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Vibration influence on control of single motor unit activity. [2009]

7. England pubmed.ncbi.nlm.nih.gov

Functional vibratory stimulation on the hand facilitates voluntary movements of a hemiplegic upper limb in a patient with stroke. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Vibratory proprioceptive stimulation affects Parkinsonian tremor. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Indirect Vibration of the Upper Limbs Alters Transmission Along Spinal but Not Corticospinal Pathways. [2023]