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

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ClinicalTrials.gov Identifier: NCT03159260
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sport and Spine Rehab Clinical Research Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Leg Cramp, Nocturnal Device: Theraworx Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Product has come in identical bottles from manufacturer. Both the investigators and statistician will remind blind until the conclusion of the study.
Primary Purpose: Treatment
Official Title: The Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms Including Quality of Life, Depression and Sleep Quality
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps
Drug Information available for: Allantoin

Arm Intervention/treatment
Experimental: Theraworx
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).
Device: Theraworx
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.

Placebo Comparator: Placebo
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).
Other: Placebo
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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. Change in Symptom Log Over 4 Weeks [ Time Frame: Weeks 1, 2, 3 and 4 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159260


Locations
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United States, Maryland
Sport and Spine Rehab
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Sport and Spine Rehab Clinical Research Foundation
  Study Documents (Full-Text)

Documents provided by Sport and Spine Rehab Clinical Research Foundation:
Informed Consent Form  [PDF] December 29, 2017


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Responsible Party: Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT03159260     History of Changes
Other Study ID Numbers: LegCramp
First Posted: May 18, 2017    Key Record Dates
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Sport and Spine Rehab Clinical Research Foundation:
night-time leg cramps
topical
spasm
Additional relevant MeSH terms:
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Muscle Cramp
Spasm
Sleep-Wake Transition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Parasomnias
Sleep Wake Disorders
Mental Disorders
Allantoin
Dermatologic Agents