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

NCT ID: NCT03159260

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2017-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Theraworx

Intervention Type: DEVICE

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

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sport and Spine Rehab

Rockville, Maryland, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LegCramp

Identifier Type: -

Identifier Source: org_study_id