Other Clinical Trial - Placebo Transcutaneous Electrical Nerve Stimulation

Status Completed

Clinical Trial Summary

Chronic musculoskeletal pain is a major problem in society. Treatments for people with musculoskeletal pain have limited efficacy. Transcutaneous Electrical Nerve Stimulation (TENS) is a commonly utilized, non-invasive treatment for pain that is a safe non-pharmacological treatment that has been utilized for treatment of musculoskeletal pain. Recent studies in animals in the PIs laboratory have begun to examine the mechanism of action of TENS. The current study is proposed to translate the findings from the animals to human subjects. One concern with TENS is that there is not an appropriate placebo. Since TENS delivers an electrical current through the skin to produce pain relief, patients can typically feel the stimulation under the electrodes. The standard placebo in prior clinical studies has been to utilize a unit that appears to be functioning (lights on) but does not deliver a current. In this case the subject would not feel the stimulation. We will compare this standard placebo to a new device in which a current is delivered for 30 seconds and then slowly ramps to off. This current would then be felt by the subject as intensity is set, and then would slowly ramp down. Thus, electrical currents will be felt by the subject. It is common for people to adapt to the TENS current so that they no longer feel the stimulation over time, or that the stimulation is felt at a lower intensity. This new placebo TENS would appear to mimic this event to the subjects. This new TENS would have the further advantage of being able to double-blind the study so that the therapist applying the treatment, and the subject receiving the treatment are unaware who is receiving the active treatment. The investigators will therefore test the adequacy of this placebo when compared to a standard placebo with no stimulation.

Hypotheses:

1. TENS will reduce temporal summation and increase nociceptive threshold in normal subjects

2. Placebo TENS with a short burst of electrical stimulation will be considered by subjects to be an active TENS unit with a greater frequency than the standard TENS unit that does not produce electrical current

3. effectiveness of TENS will be associated with genotype of candidate pain genes (SNPs).

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

Transcutaneous Electric Nerve Stimulation

Clinical Trial Details

NCT number	NCT00750321
Study type	Interventional
Source	University of Iowa
Contact
Status	Completed
Phase	N/A

View Details

See also
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Recruiting	`NCT03990441` - Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor	N/A
Completed	`NCT05362383` - Use of TENS for the Recovery of Oral Function After Orthognathic Surgery	N/A
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Completed	`NCT04749316` - Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Placebo Transcutaneous Electrical Nerve Stimulation (TENS)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms