N/A
N=57
Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms
Leg Cramp, Nocturnal
Bottom Line
View on ClinicalTrials.gov: NCT03159260 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks — 78.92; 80.75; 77.75; 83.16 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Theraworx (Device); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks |
78.92; 80.75; 77.75; 83.16; 87; 87.03 | — |
| PRIMARY Change in Beck Depression Scale Over 4 Weeks |
12.4; 8.48; 9.56; 6.92; 6.88; 5.6 | — |
| PRIMARY Change in Pittsburgh Sleep Quality Index Over 4 Weeks |
10.72; 10.12; 11; 9.52; 9.12; 7.8 | — |
| PRIMARY Change in Modified Patient Specific Functional Scale Over 4 Weeks |
4.53; 5.76; 4.99; 6.59; 6.47; 7.4 | — |
| SECONDARY Change in Symptom Log Over 4 Weeks |
5.12; 4.72; 4.72; 4.8; 4.44; 3.32 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03159260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.