Leg Cramp, NocturnalNCT03159260
Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms
A study testing Theraworx in people with Leg Cramp, Nocturnal, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Cramp, Nocturnal
- What is being tested?
- Theraworx
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who claim to have experienced night-time cramps and spasms on average at least three times per week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms Including Quality of Life, Depression and Sleep Quality
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.
Read the detailed description
50 subjects who claim to have experienced night-time cramps and spasms on average at least three times per week will be recruited. Eligible individuals will be scheduled to attend a "consent and baseline assessment" (T1). During this visit, the study will be described by a member of the research team and the subjects will be asked to provide written consent to participate in the protocol. Following providing informed consent, the subjects will be asked to complete a series of questionnaires about their demographic characteristics, presence and severity of night-time cramps and spasms symptoms, including quality of life, depression and sleep quality. Once these questionnaires are completed all subjects will complete a 14-day no treatment period in which they will be told to engage in their usual activities and treatments. Subjects will return following this two week period (T2) and complete the same questionnaires. Variables that will be collected at T2 include presence and severity of night-time cramps and spasm symptoms, including quality of life, depression and sleep quality. Subjects will be asked to refer their responses on these instruments to the previous 2 weeks following completion of the baseline assessment. Once the subjects have completed these instruments they will be randomly assigned to one of two study groups with 25 of in "Foam A" and 25 in"Foam B." Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. Following 14 consecutive days of applying the assigned foam, subjects will return to SSR (T3) and return the completed Treatment Compliance Log to the research staff. During this final visit subjects will again complete the same questionnaires that were completed during the T2 visit, referring the responses to the previous 2 weeks when the subjects were applying the assigned foam to the legs.
- Conditions
- Leg Cramp, Nocturnal
- Being tested
- Theraworx, Placebo
- Keywords
- night-time leg cramps, topical, spasm
- Medical subject headings
- Sleep-Wake Transition Disorders, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraworxDevice
Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm.
PlaceboOther
Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm.
| Study group | Role | What they receive |
|---|---|---|
| Theraworx | Experimental | Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control). Receives: Device: Theraworx |
| Placebo | Placebo comparator | Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
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, divided by total score, and multiplied by 100 to form a scale of 0 (worst outcome) to 100 (best outcome).
Measured: Baseline, 2 weeks, and 4 weeks
Change in Beck Depression Scale Over 4 Weeks
The Beck Depression Scale is one of the most widely used psychometric tests for measuring the severity of depression. The score is calculated by adding up the score for each of the twenty-one questions by counting the number to the right of each question marked. The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero. The level of depression is evaluated by: 0-10 (These ups and downs are considered normal);11-16 (Mild mood disturbance); 17-20 (Borderline clinical depression); 21-30 (Moderate depression); 31-40 (Severe depression); over 40 (Extreme depression).
Measured: Baseline, 2 weeks, and 4 weeks
Change in Pittsburgh Sleep Quality Index Over 4 Weeks
The Pittsburgh Sleep Quality Index is used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The seven component scores are added together for a global score ranging from 0 to 21, 0 indicating no difficulty and 21 indicating severe difficulties.
Measured: Baseline, 2 weeks, and 4 weeks
Change in Modified Patient Specific Functional Scale Over 4 Weeks
The Modified Patient Specific Functional Scale is used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition. Three important activities that are unable to be done or are having difficulty are rated from 0 to 10, 0 being unable to perform and 10 being able to perform activity at the same level as before injury or problem. The total score is the sum of the activity scores divided by the number of activities, ranging from 0 (worst outcome) to 10 (best outcome).
Measured: Baseline, 2 weeks, and 4 weeks
Secondary outcomes (1)
Change in Symptom Log Over 4 Weeks
Patients will track the number of times their leg cramps/spasms for the first 2 weeks without intervention and then how many times during the two weeks using the intervention.
Measured: Weeks 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Nov 2016
- Primary completion1 Jun 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leg Cramp, NocturnalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159260
- Sponsor's protocol ID
- LegCramp
- Status last verified
- Mar 2019
- First submitted
- 16 May 2017
- Last updated
- 25 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms Including Quality of Life, Depression and Sleep Quality
- ClinicalTrials.gov ID
- NCT03159260
- Acronym / sponsor ID
- LegCramp
- Conditions
- Leg Cramp, Nocturnal
- Keywords
- night-time leg cramps, topical, spasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 25 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
50 subjects who claim to have experienced night-time cramps and spasms on average at least three times per week will be recruited. Eligible individuals will be scheduled to attend a "consent and baseline assessment" (T1). During this visit, the study will be described by a member of the research team and the subjects will be asked to provide written consent to participate in the protocol. Following providing informed consent, the subjects will be asked to complete a series of questionnaires about their demographic characteristics, presence and severity of night-time cramps and spasms symptoms, including quality of life, depression and sleep quality. Once these questionnaires are completed all subjects will complete a 14-day no treatment period in which they will be told to engage in their usual activities and treatments. Subjects will return following this two week period (T2) and complete the same questionnaires. Variables that will be collected at T2 include presence and severity of night-time cramps and spasm symptoms, including quality of life, depression and sleep quality. Subjects will be asked to refer their responses on these instruments to the previous 2 weeks following completion of the baseline assessment. Once the subjects have completed these instruments they will be randomly assigned to one of two study groups with 25 of in "Foam A" and 25 in"Foam B." Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. Following 14 consecutive days of applying the assigned foam, subjects will return to SSR (T3) and return the completed Treatment Compliance Log to the research staff. During this final visit subjects will again complete the same questionnaires that were completed during the T2 visit, referring the responses to the previous 2 weeks when the subjects were applying the assigned foam to the legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theraworx | Experimental | Device: TheraworxSubjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control). |
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who claim to have experienced night-time cramps and spasms on average at least three times per week
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraworxSubjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. | Device | Theraworx |
| PlaceboSubjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. | Other | Placebo |
Primary outcome
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
Time frame: Baseline, 2 weeks, and 4 weeks
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, divided by total score, and multiplied by 100 to form a scale of 0 (worst outcome) to 100 (best outcome).
Change in Beck Depression Scale Over 4 Weeks
Time frame: Baseline, 2 weeks, and 4 weeks
The Beck Depression Scale is one of the most widely used psychometric tests for measuring the severity of depression. The score is calculated by adding up the score for each of the twenty-one questions by counting the number to the right of each question marked. The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero. The level of depression is evaluated by: 0-10 (These ups and downs are considered normal);11-16 (Mild mood disturbance); 17-20 (Borderline clinical depression); 21-30 (Moderate depression); 31-40 (Severe depression); over 40 (Extreme depression).
Change in Pittsburgh Sleep Quality Index Over 4 Weeks
Time frame: Baseline, 2 weeks, and 4 weeks
The Pittsburgh Sleep Quality Index is used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The seven component scores are added together for a global score ranging from 0 to 21, 0 indicating no difficulty and 21 indicating severe difficulties.
Change in Modified Patient Specific Functional Scale Over 4 Weeks
Time frame: Baseline, 2 weeks, and 4 weeks
The Modified Patient Specific Functional Scale is used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition. Three important activities that are unable to be done or are having difficulty are rated from 0 to 10, 0 being unable to perform and 10 being able to perform activity at the same level as before injury or problem. The total score is the sum of the activity scores divided by the number of activities, ranging from 0 (worst outcome) to 10 (best outcome).
1 secondary outcome
Change in Symptom Log Over 4 Weeks
Time frame: Weeks 1, 2, 3 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theraworx in people with Leg Cramp, Nocturnal, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks (time frame: Baseline, 2 weeks, and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.