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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for frozen shoulder, also known as adhesive capsulitis, which restricts shoulder movement. It compares two treatments involving gentle vibration on the tendons using neurostimulation devices—one with a real effect and one without—both paired with special exercises. The goal is to determine if the real vibration improves shoulder movement and reduces pain more effectively than the placebo. Individuals with a diagnosed frozen shoulder or those without shoulder pain may be suitable for this study. As an unphased trial, this study provides an opportunity to explore innovative treatments and contribute to advancing medical knowledge.

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.

What prior data suggests that these neurostimulation devices are safe for treating frozen shoulder?

Research has shown that tendon vibration for treating frozen shoulder is generally well-tolerated. Studies have found that about 90% of patients receiving this treatment, along with exercises, report good results. This suggests that tendon vibration is relatively safe and has few side effects.

Although specific information on side effects from tendon vibration alone is limited, the overall positive results indicate that serious problems are rare. Most patients regain normal shoulder movement with appropriate treatments, and early intervention can lead to better outcomes.

In this trial, tendon vibration is used with exercises and compared to a placebo vibration. The placebo does not create the intended feeling of movement. However, both procedures are safe and non-invasive, posing low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tendon vibration for frozen shoulder because it introduces a novel approach by using neurostimulation to create kinesthetic illusions, which might enhance mobility and reduce pain. Unlike traditional treatments like physical therapy and corticosteroid injections, which focus on reducing inflammation and improving range of motion through manual techniques, this treatment leverages the body's neurological responses to improve shoulder function. This method could offer a quicker and more targeted recovery process, making it a promising alternative for patients seeking relief from this often-debilitating condition.

What evidence suggests that these neurostimulation devices are effective for frozen shoulder?

Research has shown that using vibrations on tendons can help treat adhesive capsulitis, also known as frozen shoulder. In this trial, participants will join different treatment arms. One arm combines tendon vibration that induces kinesthetic illusions with a standardized exercise protocol. Another arm uses tendon vibration without inducing kinesthetic illusions, also combined with the exercise protocol. A study found that 90% of patients with this condition achieved good results with proper treatment. Starting treatment early often reduces severity and helps restore normal shoulder movement. Tendon vibration creates a feeling of movement, which can improve shoulder mobility and reduce pain. This method may lead to better results when combined with exercises. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Adhesive Capsulitis (Frozen Shoulder) - StatPearls - NCBI - NIH Approximately 80% of patients regain near-normal or normal shoulder function with proper treatment. Early intervention can lessen the severity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5384535/

Adhesive capsulitis of the shoulder: review ... In a prospective nonrandomized study, Griggs et al. documented satisfactory outcomes in 90% of patients (64 of 75) with phase-II adhesive shoulder capsulitis ...

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Comparison of Treatments for Frozen Shoulder This systematic review and meta-analysis assesses and compares the effectiveness of available treatment options for frozen shoulder to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666638323000269

Assessment of therapeutic clinical trials for adhesive ... The aim of this study is to provide an overview of therapeutic interventional clinical trials targeting adhesive capsulitis of the shoulder.

5. journalmsr.com journalmsr.com/therapeutic-effects-of-mobilization-in-alleviating-pain-and-improving-shoulder-mobility-in-adhesive-capsulitis-a-systematic-review/

Therapeutic effects of mobilization in alleviating pain and ... The pain was reduced in three of the five investigations with P < 0.05, whereas the remaining studies yielded neutral findings in lowering pain ...

6. jospt.org jospt.org/doi/10.2519/jospt.2013.0302

Shoulder Pain and Mobility Deficits: Adhesive Capsulitis The investigators found that 27% of these 75 patients continued to have mild pain with activity and that all patients demonstrated mobility ...

7. mdpi.com mdpi.com/2379-139X/9/5/147

Long-Term Outcomes of Ultrasound-Guided ... In conclusion, in this observational study, we have demonstrated that ultrasound-guided hydrodistention is linked to excellent long-term ...