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NCT03159260 · ClinicalTrials.gov registry record · NA
Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms
A NA study, sponsored by Sport and Spine Rehab Clinical Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT03159260: Completed NA study, sponsored by Sport and Spine Rehab Clinical Research Foundation.
NCT03159260 is a NA study that has completed, run by Sport and Spine Rehab Clinical Research Foundation. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03159260, a NA study, has completed, sponsored by Sport and Spine Rehab Clinical Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study 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.
Primary Outcome
Restless Legs Syndrome Quality of Life Instrument (RLSQoL) assesses the impact of restless legs symptoms on daily life, emotional well-being, social life and work life in adults 21 years and over. Each subsection is totaled separately and summed to form a total score from 0-100. Higher scores on the RLSQoL overall life impact score indicate a better quality of life. The subsections include Social Life, Daily Function, Sleep Quality, and Emotional Well-being. Each subsection questions are summed,
Interventions
- OTHER Placebo
- DEVICE Theraworx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2017-12-30 |
| Phase | NA |
What the finished NCT03159260 record still lists
NCT03159260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03159260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03159260 about?
NCT03159260 is a clinical study titled "Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms". 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.
What is the current status of trial NCT03159260?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2016-11-01. Estimated completion is 2017-12-30.
What interventions are being tested in trial NCT03159260?
The interventions under investigation include: Placebo (OTHER), Theraworx (DEVICE).
Who is sponsoring clinical trial NCT03159260?
This trial is sponsored by Sport and Spine Rehab Clinical Research Foundation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03159260's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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