CompletedNot Applicable

Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms

United States57 participantsStarted 2016-11-01

Plain-language summary

The purpose of this study is to determine the effect of Theraworx/\[pH\]uel on the frequency and severity of night-time cramps and spasms symptoms, including quality of life, depression and sleep quality when compared to a placebo.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects who claim to have experienced night-time cramps and spasms on average at least three times per week Exclusion Criteria: * Individuals will be excluded from the study if they are pregnant, have been previously diagnosed with a non-RLS sleep disorder, previously diagnosed with schizophrenia or any other neurological disorder

What they're measuring

Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks

Timeframe: Baseline, 2 weeks, and 4 weeks

Change in Beck Depression Scale Over 4 Weeks

Timeframe: Baseline, 2 weeks, and 4 weeks

Change in Pittsburgh Sleep Quality Index Over 4 Weeks

Timeframe: Baseline, 2 weeks, and 4 weeks

Change in Modified Patient Specific Functional Scale Over 4 Weeks

Timeframe: Baseline, 2 weeks, and 4 weeks

Trial details

NCT IDNCT03159260

SponsorSport and Spine Rehab Clinical Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-01

Results submitted2017-12-29

View on ClinicalTrials.gov More Leg Cramp, Nocturnal trials