CrampsRELAXNCT05457322
The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
A study testing Behavioral intervention one and Behavioral intervention two in people with Cramps and Muscle Cramp, run by University of Michigan at 6 sites in United States.
Trial summary
The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis. Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cramps, Muscle Cramp
- What is being tested?
- Behavioral intervention one and Behavioral intervention two
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Aug 2022to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
- Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
- For Cirrhosis patients only: diagnosis of cirrhosis based upon:
- liver biopsy, or
- history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
- 2 of the following 4 criteria:
Show all 10Show fewer
- Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- FibroScan liver stiffness score >13 kilopascal (kPa)
- Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0
- CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
Who cannot join
- Non-English speaking
- Unable or unwilling to provide consent
- Pregnancy via self-report
- Disorientation at the time of enrollment
- History of multiple sclerosis
- History of cerebral palsy
- History of stroke with paralysis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Baylor
Dallas, Texas, 75246
Cedars-Sinai
Los Angeles, California, 90048
University of Miami Health System
Miami, Florida, 33125
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis.
Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.
Read the detailed description
The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.
- Conditions
- Cramps, Muscle Cramp
- Being tested
- Behavioral intervention one, Behavioral intervention two
- Keywords
- Nighttime muscle cramps, Cirrhosis, Liver disease, Qualify of life, Sleep, Non-Pharmaceutical intervention
- Medical subject headings
- Muscle Cramp, Fibrosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intervention oneBehavioural
Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.
Behavioral intervention twoBehavioural
Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention one | Experimental | Not described Receives: Behavioral: Behavioral intervention one |
| Behavioral intervention two | Experimental | Not described Receives: Behavioral: Behavioral intervention two |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.
Measured: baseline, 35 days
Secondary outcomes (2)
Patient global impression of change (PGIC)
This is a one question survey in which the participants rate overall status as one of the following:
Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. Comparison of PGIC scores at 35 days between both arms.
Measured: 35 days
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
This is a one question survey in which the participants rate overall sleep quality as one of the following: Very good, Good, Fair, Bad, Very bad.
Measured: baseline, 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start30 Aug 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CrampsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457322
- Sponsor's protocol ID
- HUM00216488
- Acronym
- RELAX
- Status last verified
- Sep 2023
- First submitted
- 9 Jul 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tapper EB, Trivedi H, Simonetto DA, Patwardhan V, Ospina E, Martinez B, Chen X, Walker S, Nikirk S. The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps. Liver Int. 2024 Sep;44(9):2434-2441. doi: 10.1111/liv.16007. Epub 2024 Jun 11.
PubMed 38860445
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
- ClinicalTrials.gov ID
- NCT05457322
- Acronym / sponsor ID
- RELAX / HUM00216488
- Conditions
- Cramps, Muscle Cramp
- Keywords
- Nighttime muscle cramps, Cirrhosis, Liver disease, Qualify of life, Sleep, Non-Pharmaceutical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
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 the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis.
Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.
Detailed description
The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention one | Experimental | Behavioral: Behavioral intervention one |
| Behavioral intervention two | Experimental | Behavioral: Behavioral intervention two |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
- Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
- For Cirrhosis patients only: diagnosis of cirrhosis based upon:
- Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- FibroScan liver stiffness score >13 kilopascal (kPa)
Key exclusion criteria (7 listed)
- Non-English speaking
- Unable or unwilling to provide consent
- Pregnancy via self-report
- Disorientation at the time of enrollment
- History of multiple sclerosis
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 |
|---|---|---|
| Behavioral intervention oneParticipants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to. | Behavioural | Behavioral intervention one |
| Behavioral intervention twoParticipants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to. | Behavioural | Behavioral intervention two |
Primary outcome
Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
Time frame: baseline, 35 days
This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.
2 secondary outcomes
Patient global impression of change (PGIC)
Time frame: 35 days
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: baseline, 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 38860445Tapper EB, Trivedi H, Simonetto DA, Patwardhan V, Ospina E, Martinez B, Chen X, Walker S, Nikirk S. The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps. Liver Int. 2024 Sep;44(9):2434-2441. doi: 10.1111/liv.16007. Epub 2024 Jun 11.
- 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.
Elliot Tapper, MD principal investigator
University of Michigan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention one and Behavioral intervention two in people with Cramps and Muscle Cramp, run by University of Michigan at 6 sites 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 10 inclusion and 7 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cramp severity after 35-days as measured by the Visual Analog Scale for Cramps (time frame: baseline, 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457322, which also lists 1 linked publication.
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 11 Sep 2023.