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Brain Stimulation + Physical Therapy for Chronic Knee Pain

N/A

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 18 years old

Knee pain duration >/= 3 months

Must not have

History of surgery on affected knee

Presence of any other skin or scalp condition that could be aggravated by tDCS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial aims to see if using a brain stimulation technique called tDCS along with physical therapy can help improve pain and function in people with chronic knee pain. The study will compare the effects of real

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of tDCS may include mild tingling, itching or discomfort at the electrode site on the head, fatigue, headache, nausea or mood changes during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had knee pain for 3 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my knee.

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I do not have skin or scalp conditions that could worsen with tDCS treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain (NPRS)

Recruitment ratio

Two-minute walk test (2MWT)

Secondary study objectives

Five time sit to stand (5STS)

Lower extremity functional scale (LEFS)

Patient specific functional scale (PSFS)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active tDCS+PTExperimental Treatment2 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+PTPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial direct current stimulation

2013

Completed Phase 3

~1430

0 / 4Eligibility criteria met