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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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