Brain Stimulation + Physical Therapy for Chronic Knee Pain

Overseen By Sangeetha Madhavan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Knee surgery, Pregnancy, Skin conditions, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 sessions

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of brain stimulation and physical therapy to determine its effectiveness in reducing chronic knee pain and improving function. The brain stimulation technique, transcranial direct current stimulation (tDCS), targets the brain to potentially reduce pain by altering pain signal processing. Participants will receive either active tDCS or a sham (inactive) version, along with physical therapy sessions. This study is for individuals who have experienced knee pain for over three months and have not undergone surgery on that knee. As an unphased trial, it offers a unique opportunity to explore innovative treatments for chronic knee pain.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial direct current stimulation is safe for treating chronic knee pain?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. Studies have demonstrated that using tDCS at 2 mA for 20 minutes is safe, even for older adults with long-term knee pain. Participants typically do not experience significant side effects. Another study found that combining tDCS with exercise is both safe and practical. Although more information is needed about its safety for people with chronic pain, these findings suggest that tDCS is a promising option without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of transcranial direct current stimulation (tDCS) and physical therapy for chronic knee pain because it offers a non-invasive approach that targets the brain to manage pain. Unlike standard treatments such as medications and injections that primarily focus on the knee itself, tDCS works by stimulating specific brain regions associated with pain perception, potentially offering relief without the side effects of drugs. Additionally, this method is paired with physical therapy to enhance its effectiveness, providing a holistic approach to pain management. This combination could lead to more targeted and efficient pain relief, making it a promising alternative for those who struggle with chronic knee pain.

What evidence suggests that this trial's treatments could be effective for chronic knee pain?

Research has shown that transcranial direct current stimulation (tDCS) can help manage knee pain. Studies have found that tDCS can reduce pain levels and sensitivity in people with knee osteoarthritis (OA). For instance, applying tDCS to the brain area controlling movement can ease pain and improve walking. In this trial, participants will join either an active tDCS group or a sham tDCS group, both combined with physical therapy. tDCS also shows promise for treating other long-term pain conditions, such as fibromyalgia and nerve pain. These findings suggest that tDCS could be a valuable addition to physical therapy for those with chronic knee pain. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had knee pain for at least 3 months and haven't had surgery in that area. It's ideal for those scheduled to receive physical therapy but haven't found relief from traditional treatments.

Inclusion Criteria

I experience knee pain.

I have had knee pain for 3 months or more.

Exclusion Criteria

Pregnant

Skin hypersensitivity

History of contact dermatitis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) in conjunction with individualized physical therapy for 8 sessions

8 sessions

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests if brain stimulation (tDCS) combined with personalized physical therapy can better improve pain and function in chronic knee pain sufferers than fake stimulation with the same therapy.

How Is the Trial Designed?

Group I: active tDCS+PT Experimental Treatment 2 Interventions

For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm\^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The intensity will be set at 2mA for the active tDCS group, following a 30 second ramp-up time. The participants in the active tDCS group will undergo 20 minutes of tDCS treatment prior to receiving individualized PT intervention.

Group II: sham tDCS+PT Placebo Group 2 Interventions

For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT tDCS device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm\^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The participants in the sham tDCS group will undergo 20 minutes of sham tDCS treatment prior to receiving individualized PT intervention.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

In a study involving 80 individuals with chronic knee osteoarthritis, adding transcranial direct current stimulation (tDCS) to conventional physiotherapy significantly improved pain levels, knee-related disability, and physical performance compared to sham tDCS.

tDCS applied over the primary motor cortex (M1) showed the most consistent benefits, enhancing pain relief and functional outcomes both immediately after treatment and one month later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct stimulation as an add-on treatment to conventional physical therapy on pain intensity and functional ability in individuals with knee osteoarthritis: A randomized controlled trial. Rahimi, F., Nejati, V., Nassadj, G., et al.[2021]

In a study involving 40 older adults with knee osteoarthritis, transcranial direct current stimulation (tDCS) significantly increased pain thresholds and tolerances, indicating its efficacy in reducing experimental pain sensitivity.

The improvements in experimental pain measures from tDCS were linked to reductions in clinical pain, suggesting that tDCS could be a promising non-invasive treatment for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. Ahn, H., Suchting, R., Woods, AJ., et al.[2022]

Anodal transcranial direct current stimulation (M1-a-tDCS) has been shown to significantly reduce pain in individuals with knee osteoarthritis (KOA), with a moderate effect size in a meta-analysis of 14 studies involving 740 participants.

M1-a-tDCS can be effective both as a standalone treatment and when combined with other therapies, although the overall certainty of these findings is low due to potential biases and small sample sizes in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of anodal tDCS on pain reduction in people with knee osteoarthritis: A systematic review and meta-analysis. Dissanayaka, T., Nakandala, P., Malwanage, K., et al.[2023]

The study involved 30 participants with knee osteoarthritis who received either active transcranial direct current stimulation (tDCS) combined with exercise or a sham treatment for 8 weeks, showing that adding tDCS is safe and feasible.

While both groups experienced pain reduction, only the active tDCS group showed significant improvements in function and pressure pain thresholds, suggesting that tDCS may enhance the benefits of exercise in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. Chang, WJ., Bennell, KL., Hodges, PW., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) combined with physical therapy shows a significant reduction in pain for conditions like fibromyalgia and knee osteoarthritis, although the overall quality of evidence is low due to high variability among studies.

The analysis indicates that tDCS may be particularly effective when paired with exercise-based physical therapy, suggesting a potential strategy for enhancing pain relief in musculoskeletal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) combined with Physical Therapy on Common Musculoskeletal Conditions: A Systematic Review and Meta-Analysis. Teixeira, PEP., Alawdah, L., Alhassan, HAA., et al.[2020]

In a study of 25 older adults with chronic musculoskeletal pain, those receiving transcranial direct current stimulation (tDCS) combined with physical therapy showed significant improvements in pain levels, depression, and quality of life after 8 weeks compared to a sham treatment group.

At the 1-month follow-up, the active tDCS group continued to demonstrate better outcomes in pain, physical activity, and quality of life, suggesting that tDCS could be an effective regular treatment for enhancing both physical and mental health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on physical and mental health in older adults with chronic musculoskeletal pain: a randomized controlled trial. Kim, S., Salazar Fajardo, JC., Seo, E., et al.[2022]

In a study involving 80 healthy participants, high-definition transcranial direct current stimulation (HD-tDCS) did not significantly reduce pain intensity from nerve growth factor-induced pain, indicating limited efficacy in acute pain relief.

However, HD-tDCS was effective in reducing the facilitation of temporal summation of pain in participants experiencing induced pain, suggesting that its benefits may be more pronounced in individuals with sensitized central pain mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. Kold, S., Graven-Nielsen, T.[2023]

A study involving 20 older adults with knee osteoarthritis showed that home-based self-administered transcranial direct current stimulation (tDCS) was feasible and led to significant improvements in clinical pain severity and sleep disturbances after 10 sessions.

Participants completed all sessions without serious side effects, indicating that this method of tDCS could be a safe and effective option for managing pain in older adults, although it did not significantly reduce anxiety or depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. Ahn, H., Sorkpor, S., Miao, H., et al.[2019]

Citations

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Transcranial direct current stimulation enhances the efficacy of ... Repeated-measures ANOVA indicated that tDCS significantly improved the efficacy of TENS in alleviating pain and enhancing walking ability among ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0987705323000758

Efficacy of transcranial direct current stimulation in patients ... The results of this review suggest that tDCS holds promise as a pain management intervention for individuals with knee OA. Notably, anodal tDCS applied over the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485468/

Effects of Transcranial Direct Current Stimulation on pain and ... Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord injury and stroke ...

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Effects of transcranial direct current stimulation on pain and ... The results of our meta-analysis showed that tDCS was effective in relieving short-term pain intensity and pain sensitivity in patients with KOA ...

5. mdpi.com mdpi.com/2076-3417/14/16/7100?

Transcranial Direct Current Stimulation in the Treatment of ... This scoping review aims to evaluate the efficacy of tDCS in treating chronic knee pain among older adults. Methods: A comprehensive search of peer-reviewed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12421619/

Dosage and safety of transcranial magnetic stimulation and ... Additionally, safety profiles for these non-invasive brain stimulation interventions in patients with CMP remain insufficiently reported, with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06132412

Transcranial Direct Current Stimulation in Conjunction with ... Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that can have neuromodulatory effects on central nervous system ...

8. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14887

The safety and feasibility of transcranial direct current ... We found tDCS + ET was safe, feasible, and tolerable. Secondary outcomes suggested active tDCS + ET was superior to sham tDCS + ET when ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21000462

Motor cortex transcranial direct current stimulation effects ... 2 mA for 20 min of anodal tDCS is safe and well tolerated in the elderly. •. tDCS alone did not induce long-term effects in the elderly with knee chronic pain.