Home-based FES for Frozen Shoulder

Overseen By Sanjana Rao, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Shoulder tumors, Fracture, Surgery, Osteoporosis, Rheumatic disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new home-based treatment using Functional Electrical Stimulation (FES) to determine its effectiveness in improving pain and shoulder function in individuals with frozen shoulder, a condition causing pain and stiffness. Participants will use a device at home in addition to their usual therapy sessions at the clinic. The trial seeks individuals who have experienced shoulder pain and limited movement for more than four weeks, have been diagnosed with frozen shoulder, and can tolerate electrical stimulation. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment options for frozen shoulder.

Do I have to stop taking my current medications for the trial?

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 this home-based FES is safe for individuals with shoulder adhesive capsulitis?

Research has shown that using Functional Electrical Stimulation (FES) at home is generally safe for treating frozen shoulder. Users have experienced improved shoulder movement without major side effects.

Studies have found that FES can enhance shoulder movement by 50% in lifting the arm and 60% in extending it. This indicates that the treatment is effective and not harmful.

Some individuals might feel slight discomfort from the electrical pulses, but the treatment is designed to be gentle. The device is set to the lowest effective level to prevent strong muscle contractions.

In summary, home-based FES appears to be a safe option for those with frozen shoulder. It is important to consult a healthcare provider if there are any concerns before starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for frozen shoulder, which often involve physical therapy, anti-inflammatory medications, or steroid injections, the home-based Functional Electrical Stimulation (FES) offers a unique, non-invasive approach. This treatment uses a Genesis Flex FES device that delivers mild electrical impulses to the shoulder joint through adhesive electrodes, helping to stimulate muscles without causing painful contractions. Researchers are excited about this method because it allows patients to manage their condition comfortably at home, potentially speeding up recovery by encouraging muscle engagement and movement in a more natural and consistent manner.

What evidence suggests that home-based FES is effective for frozen shoulder?

Research has shown that Functional Electrical Stimulation (FES) can help people with frozen shoulder improve shoulder movement and reduce pain. In this trial, participants will use a home-based FES device, the Genesis Flex, alongside usual rehabilitation care. Studies have found that combining FES with certain techniques enhances shoulder movement and reduces discomfort. Specifically, another study found that using FES with exercises effectively decreases shoulder pain and upper arm issues. Overall, FES appears promising for reducing stiffness and improving movement in those with frozen shoulder. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder conditions known as Pes Anserine Bursitis or Frozen Shoulder. It's designed to see if using Functional Electrical Stimulation (FES) at home, along with regular therapy, helps reduce pain and improve shoulder function.

Inclusion Criteria

I have been diagnosed with frozen shoulder.

I have had shoulder pain and limited movement for over 4 weeks, but my x-rays and nerve tests are normal.

Can tolerate electrical stimulation

Exclusion Criteria

I have tumors or bone lesions in my shoulder.

I have had a shoulder fracture or dislocation in the past.

I have had shoulder surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline clinical assessments and receive education on the use of the Genesis FES device

1 day

1 visit (in-person)

Treatment

Participants use the Genesis Flex FES device at home daily for 4 weeks, with clinical assessments at 2 weeks and 4 weeks

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in shoulder range of motion, pain, and usability of the FES device

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based FES

Trial Overview The study tests the use of a home-based FES device in combination with usual therapeutic practices for treating adhesive capsulitis of the shoulder. The goal is to determine whether this approach can enhance pain relief and functional recovery.

How Is the Trial Designed?

Group I: Home-based FES Experimental Treatment 1 Intervention

The intervention will include home use of Genesis Flex FES device alongside usual rehabilitation care. Participant education in Genesis FES use will be conducted during the baseline assessment session. FES parameters will be initially adjusted at the lowest possible current for patient comfort with the constraint that they should not elicit a tetanic contraction. FES will be provided via two self adhesive electrodes attached across shoulder joint.A shoulder harness adjustable neoprene padding will be provided to enable anatomical contouring for patient comfort and support for positioning of stimulator and electrodes to the affected shoulder.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227662

Feasibility, Usability and Preliminary Efficacy of Home- ... The purpose of this study is to investigate the feasibility, usability and preliminary efficacy of a home-based Functional Electrical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8139297/

Intramuscular Electrical Stimulation Combined with ... IMES combined with therapeutic exercises is an effective treatment to reduce the shoulder pain severity and upper limb disability.

3. jhrlmc.com jhrlmc.com/index.php/home/article/download/1408/1311

Effect of Functional Electrical Stimulation with and without ... Conclusion: Combining FES with Mulligan's technique significantly improves shoulder mobility and reduces pain in adhesive capsulitis patients ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2774247

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 ...

5. researchgate.net researchgate.net/publication/391968130_Effectiveness_of_Functional_Electrical_Stimulation_Versus_Spencer_Technique_in_Patients_with_Adhesive_Capsulitis

Effectiveness of Functional Electrical Stimulation Versus ... Objective: To compare functional electrical stimulation with spencer approach for relieving pain, stiffness and enhance range of motion and functional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07227662?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapy

Feasibility, Usability and Preliminary Efficacy of Home- ... The purpose of this study is to investigate the feasibility, usability and preliminary efficacy of a home-based Functional Electrical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10898218/

Electrotherapy modalities for adhesive capsulitis (frozen ... The main outcomes of interest were participant‐reported pain relief of 30% or greater, overall pain, function, global assessment of treatment success, active ...

8. e-arm.org e-arm.org/upload/pdf/arm_v49n3_full.pdf

www.e-arm.org improve outcomes for people with frozen shoulder? A randomized · controlled ... idiopathic adhesive capsulitis of shoulder (frozen shoulder). Int J. Pharm ...

9. researchgate.net researchgate.net/publication/383844863_Effect_of_Functional_Electrical_Stimulation_with_and_without_Mulligan's_Technique_in_Adhesive_Capsulitis_FES_and_Mulligan's_Technique_in_Adhesive_Capsulitis

FES and Mulligan's Technique in Adhesive Capsulitis Results: Group B showed a 50% improvement in shoulder flexion (z = -2.946, p = 0.003) and a 60% improvement in shoulder extension (z = -2.980, p = 0.003) ...