Muscular CrampsMassageNCT04990661
The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality
A study testing intradialytic massage in people with Muscular Cramps and Hemodialysis, run by Kafkas University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Cramps, Hemodialysis
- What is being tested?
- intradialytic massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 21 Jun 2021
- 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
- 18 years,
- One or more lower work cramp attacks during/after dialysis
- Have a constant dryness in the last 1 month (few changes weighing more than 2 kg)
- Receiving at least 6 hemodialysis treatments
- Receiving hemodialysis treatment 3 times a week
- Those who have not received sub-massage therapy before
Who cannot join
- Having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease
- Presence of any soft tissue, nerve and vascular disease in the lower extremities
- Presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities
- Having had a lower extremity operation in the past six weeks
- Receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability)
- Having a fluctuating dry weight (excluded from the study as it may cause cramping)
- Having been diagnosed with neuropathy in the lower extremities
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ayşe Gül Parlak
Kars, 36000
Kafkas University
Kars, 36000
About this study
Official title: The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp
The aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.
Read the detailed description
The study was conducted with patients receiving treatment in a total of four hemodialysis units. The sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. In the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. No intervention other than routine care was applied to the control group patients.
In the study, the data were collected using a patient information form, cramp assessment short survey, the "Visual Analog Scale (VAS)", "Pittsburgh Sleep Quality Index" (PUKİ), and patient follow-up forms.
In order to conduct the study, the necessary Ethics Committee approval and institutional permission were obtained. The individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed.
After the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.
- Conditions
- Muscular Cramps, Hemodialysis
- Being tested
- intradialytic massage
- Keywords
- Hemodialysis, massage, muscle cramps, sleep quality
- Medical subject headings
- Muscle Cramp, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradialytic massageBehavioural
intradialytic massage for lower extremity ( the massage included both feet and legs up to and including the knee) applied to the intervention group in three sessions a week and a total of six sessions for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (massage group) | Experimental | intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks Receives: Behavioral: intradialytic massage |
| Control group | No intervention | not administered except nursing interventions in the HD unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scala (VAS)
This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. Participants marked the scale each time they experience a muscle cramp severity. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Measured: during 2 weeks (15 days)
Muscle cramp assessment short survey (duration and frequency of muscle cramps)
Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Measured: during 2 weeks (15 days)
Patient follow-up forms.
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
Measured: during 2 weeks (15 days)
Secondary outcomes (1)
Pittsburgh Sleep Quality Index(PUKİ),
Pittsburgh Sleep Quality Index (PUKI) used to evaluate sleep quality.The total score is between 0-21. PUKİ score of 5 or above indicates poor sleep quality.
Measured: At the first and last meeting in 2 weeks (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscular CrampsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Gul Parlak, Kafkas University
- Investigators
- ayşe gül parlak, Principal investigator, Kafkas Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990661
- Sponsor's protocol ID
- Kafkas Unıversity
- Acronym
- Massage
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mastnardo D, Lewis JM, Hall K, Sullivan CM, Cain K, Theurer J, Huml A, Sehgal AR. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial. Int J Ther Massage Bodywork. 2016 Jun 3;9(2):3-8. doi: 10.3822/ijtmb.v9i2.305. eCollection 2016 Jun.
PubMed 27257445Cox KJ, Parshall MB, Hernandez SHA, Parvez SZ, Unruh ML. Symptoms among patients receiving in-center hemodialysis: A qualitative study. Hemodial Int. 2017 Oct;21(4):524-533. doi: 10.1111/hdi.12521. Epub 2016 Dec 19.
PubMed 27990732Flythe JE, Hilliard T, Lumby E, Castillo G, Orazi J, Abdel-Rahman EM, Pai AB, Rivara MB, St Peter WL, Weisbord SD, Wilkie CM, Mehrotra R; Kidney Health Initiative Prioritizing Symptoms of ESRD Patients for Developing Therapeutic Interventions Stakeholder Meeting Participants. Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue. Clin J Am Soc Nephrol. 2019 Jan 7;14(1):150-160. doi: 10.2215/CJN.07670618. Epub 2018 Nov 5.
PubMed 30397026
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp
- ClinicalTrials.gov ID
- NCT04990661
- Acronym / sponsor ID
- Massage / Kafkas Unıversity
- Conditions
- Muscular Cramps, Hemodialysis
- Keywords
- Hemodialysis, massage, muscle cramps, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 4 Aug 2021 (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 aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.
Detailed description
The study was conducted with patients receiving treatment in a total of four hemodialysis units. The sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. In the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. No intervention other than routine care was applied to the control group patients.
In the study, the data were collected using a patient information form, cramp assessment short survey, the "Visual Analog Scale (VAS)", "Pittsburgh Sleep Quality Index" (PUKİ), and patient follow-up forms.
In order to conduct the study, the necessary Ethics Committee approval and institutional permission were obtained. The individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed.
After the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (massage group) | Experimental | Behavioral: intradialytic massageintradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks |
| Control group | No intervention | –not administered except nursing interventions in the HD unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years,
- One or more lower work cramp attacks during/after dialysis
- Have a constant dryness in the last 1 month (few changes weighing more than 2 kg)
- Receiving at least 6 hemodialysis treatments
- Receiving hemodialysis treatment 3 times a week
Key exclusion criteria (7 listed)
- Having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease
- Presence of any soft tissue, nerve and vascular disease in the lower extremities
- Presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities
- Having had a lower extremity operation in the past six weeks
- Receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability)
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 |
|---|---|---|
| intradialytic massageintradialytic massage for lower extremity ( the massage included both feet and legs up to and including the knee) applied to the intervention group in three sessions a week and a total of six sessions for two weeks | Behavioural | Intervention group (massage group) |
Primary outcome
Visual Analog Scala (VAS)
Time frame: during 2 weeks (15 days)
This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. Participants marked the scale each time they experience a muscle cramp severity. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Muscle cramp assessment short survey (duration and frequency of muscle cramps)
Time frame: during 2 weeks (15 days)
Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Patient follow-up forms.
Time frame: during 2 weeks (15 days)
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
1 secondary outcome
Pittsburgh Sleep Quality Index(PUKİ),
Time frame: At the first and last meeting in 2 weeks (15 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 4 Aug 2021.
- Background: PubMed 27257445Mastnardo D, Lewis JM, Hall K, Sullivan CM, Cain K, Theurer J, Huml A, Sehgal AR. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial. Int J Ther Massage Bodywork. 2016 Jun 3;9(2):3-8. doi: 10.3822/ijtmb.v9i2.305. eCollection 2016 Jun.
- Background: PubMed 27990732Cox KJ, Parshall MB, Hernandez SHA, Parvez SZ, Unruh ML. Symptoms among patients receiving in-center hemodialysis: A qualitative study. Hemodial Int. 2017 Oct;21(4):524-533. doi: 10.1111/hdi.12521. Epub 2016 Dec 19.
- Background: PubMed 30397026Flythe JE, Hilliard T, Lumby E, Castillo G, Orazi J, Abdel-Rahman EM, Pai AB, Rivara MB, St Peter WL, Weisbord SD, Wilkie CM, Mehrotra R; Kidney Health Initiative Prioritizing Symptoms of ESRD Patients for Developing Therapeutic Interventions Stakeholder Meeting Participants. Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue. Clin J Am Soc Nephrol. 2019 Jan 7;14(1):150-160. doi: 10.2215/CJN.07670618. Epub 2018 Nov 5.
- 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.
ayşe gül parlak principal investigator
Kafkas Üniversity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradialytic massage in people with Muscular Cramps and Hemodialysis, run by Kafkas University at 2 sites in Turkey (Türkiye).
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 6 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Visual Analog Scala (VAS) (time frame: during 2 weeks (15 days)). The study lists 3 primary outcomes in all. 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 NCT04990661, which also lists 3 linked publications.
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 4 Aug 2021.