Muscle CrampNCT07293182
Compression Stockings for Prevention of Hemodialysis Muscle Cramps
A study testing compression stockings in people with Muscle Cramp, run by Karbala University at 2 sites in Iraq.
Trial summary
the Objectives of this clinical trial is : 1. examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients. 2. Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Cramp
- What is being tested?
- compression stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesIraq
- Study dates
- 21 Dec 2025to 15 Apr 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are at least eighteen years old.
- Both genders (male \& female).
- Patients who are conscious and cooperative.
- Patients experiencing muscle cramps during previous hemodialysis session.
- Patients who would like to participate in part in the study .
- Patients with verbally communicated skills.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Imam AL-Hassan AL-Mujtaba Teaching Hospital
Karbala, Karbala Governorate
Imam Al-Hussein Medical City (Habib Ibn Mudaher Al-Asadi center)
Karbala, Karbala Governorate
About this study
Official title: The Role of Using Elastic Compression Stockings in the Prevention of Muscles Cramps Episode in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
the Objectives of this clinical trial is :
- examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients.
- Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical data.
Read the detailed description
Intradialytic muscles cramps are frequent complication, and common cause of early hemodialysis (HD) termination. These cramps are thought to be precipitated by intradialytic venous stasis and reduced tissue perfusion. Elastic compression stockings (ECS), compress the calf and thigh to counteract venous pooling, and increase venous return.
- Conditions
- Muscle Cramp
- Being tested
- compression stockings
- Keywords
- Elastic Compression Stockings, Muscle Cramps, Hemodialysis.
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression stockingsDevice
Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session.
| Study group | Role | What they receive |
|---|---|---|
| compression stockings group | Experimental | Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session. Receives: Device: compression stockings |
| control group | No intervention | Patients in the control group received their usual medical care during hemodialysis without any additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cramp Questionnaire Chart
The instrument was developed by Morris (2014), and permission was obtained from the author. It was used in the study to assess patients' muscle cramps. This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature, and discomfort. These features are comprehensively scored as a level of muscle cramps ranging from 0 to 13.
Measured: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
Visual analogue scale (VAS) for pain
The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain. It was initially introduced by Hayes and Patterson in 1921. Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm).
Measured: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start21 Dec 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle CrampStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the HD session. This was performed once per day for a single HD session. While Patients in the control group received their usual medical care during HD without any additional interventions.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahraa Adel Kareem, Karbala University
- Investigators
- zahraa A Kareem, MGS, Principal investigator, kerbala heath department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293182
- Sponsor's protocol ID
- UOK.CON.25.091
- Status last verified
- May 2026
- First submitted
- 6 Dec 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared publicly due to ethical and confidentiality restrictions as specified in the informed consent form and approved by the Institutional Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Using Elastic Compression Stockings in the Prevention of Muscles Cramps Episode in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07293182
- Acronym / sponsor ID
- UOK.CON.25.091
- Conditions
- Muscle Cramp
- Keywords
- Elastic Compression Stockings, Muscle Cramps, Hemodialysis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 19 Dec 2025 (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 Objectives of this clinical trial is :
- examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients.
- Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical data.
Detailed description
Intradialytic muscles cramps are frequent complication, and common cause of early hemodialysis (HD) termination. These cramps are thought to be precipitated by intradialytic venous stasis and reduced tissue perfusion. Elastic compression stockings (ECS), compress the calf and thigh to counteract venous pooling, and increase venous return.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the HD session. This was performed once per day for a single HD session. While Patients in the control group received their usual medical care during HD without any additional interventions.
| Arm | Type | Receives |
|---|---|---|
| compression stockings group | Experimental | Device: compression stockingsPatients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session. |
| control group | No intervention | –Patients in the control group received their usual medical care during hemodialysis without any additional interventions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are at least eighteen years old.
- Both genders (male \& female).
- Patients who are conscious and cooperative.
- Patients experiencing muscle cramps during previous hemodialysis session.
- Patients who would like to participate in part in the study .
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| compression stockingsPatients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session. | Device | compression stockings group |
Primary outcome
Cramp Questionnaire Chart
Time frame: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
The instrument was developed by Morris (2014), and permission was obtained from the author. It was used in the study to assess patients' muscle cramps. This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature, and discomfort. These features are comprehensively scored as a level of muscle cramps ranging from 0 to 13.
Visual analogue scale (VAS) for pain
Time frame: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain. It was initially introduced by Hayes and Patterson in 1921. Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm).
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 19 May 2026.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared publicly due to ethical and confidentiality restrictions as specified in the informed consent form and approved by the Institutional Review Board.
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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.
zahraa A Kareem, MGS principal investigator
kerbala heath department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression stockings in people with Muscle Cramp, run by Karbala University at 2 sites in Iraq.
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 0 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 19 May 2026. 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 Iraq. 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?
Cramp Questionnaire Chart (time frame: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session). The study lists 2 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 19 May 2026.