Hemodialysis ComplicationNCT06098443
Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis
A study testing Acupressure and Transcutaneous electrical nerve stimulation in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Hemodialysis patients have a high prevalence of pain, mainly musculoskeletal and intra dialytic pain. A high prevalence of pain was also observed in the upper and lower limbs and the trunk. In addition, severe functional interference of pain in the ability to walk was associated with pain in the upper Limb. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Acupressure and Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2023to 22 Apr 2024
- 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • Sixty patients with renal failure stage 5 undergoing hemodialysis sessions at least six months ago up to 2 years.
- Participants with lower limb pain and brief pain inventory (BPI) pain score between 7 and 10 points.
- Body mass index ranges from 25 to 29.9.
- Their ages range from 50-60 years old.
- All patients will be under full medical control.
- Patients will be free from lower limb dialysis grafting.
- Hemoglobin level more than 10 mg\dl.
Who cannot join
- Skin disease such as dermatitis, stitches and wound.
- Active infection, autoimmune diseases and malignancy.
- Severe cardiac diseases.
- Severe chest diseases.
- Patients with cardiac pacemaker.
- Epilepsy.
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- Using another integrative treatment method during the study.
- Uncontrolled diabetes.
- Deep vein thrombosis.
- Lumber disc prolapses affect lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Hemodialysis patients have a high prevalence of pain, mainly musculoskeletal and intra dialytic pain. A high prevalence of pain was also observed in the upper and lower limbs and the trunk. In addition, severe functional interference of pain in the ability to walk was associated with pain in the upper Limb. These results indicate that pain in hemodialysis patients is limiting and disabling (Dos Santos et al., 2021).
Acupressure increases relaxation, relieves pain, and reduces anxiety and depression, especially in the elderly. It is relatively inexpensive, safe, non-invasive, and easy to use and is performed by hands, elbows. by applying pressure to specific areas of the body so muscle spasms are relieved, blood circulation and vital energy are improved (Bastani et al.,2022).
Strong non-painful TENS within or close to the site of pain produces clinically important reductions in the intensity of pain during or immediately after treatment. With no reports of serious adverse events. TENS as an adjunct to core treatment or immediate short-term relief of pain, irrespective of diagnosis. Patients should be advised to tailor TENS Treatment according to their individual needs (Johnson et al., 2022).
Read the detailed description
Sixty patients will be randomly assigned into two equal groups (n=30):
- Group A (30 patients) will receive Acupressure three times per week for eight weeks.
- Group B (30 patients) will receive TENS three times per week for eight weeks.
- Conditions
- Hemodialysis Complication
- Being tested
- Acupressure, Transcutaneous electrical nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure is effective on anxiety and depression management. acupressure therapy at K1, ST36, and SP6 acupoints significantly reduced anxiety \& depression in patients with ESRD.
Transcutaneous electrical nerve stimulationDevice
TENS lead to meaningful reduction of pain in patients suffering from difficult to treat phantom limb pain. This treatment has a high success rate and is associated with high satisfaction rates and no reported adverse events. The suggested duration of treatment is at least 30 minutes and may be extended up to 45 minutes. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extra segmental analgesia. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extrasegmental analgesia. (Vathakul et al., 2022).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | The acupressure points will be determined, patients are informed that they will feel soft vibrations and pain during acupressure application. Patients are advised that it is sufficient for them to feel the vibrations of the acupressure device slightly. It be felt first symmetrically right knee, right leg, left knee, left leg Patients will receive acupressure 24 sessions three times a week for eight weeks. After application the patient will be asked about the severity of pain half an hour after administration (Çevik \& Taşcı, 2020). Receives: Other: Acupressure |
| Transcutaneous electrical nerve stimulation | Active comparator | • Placement electrodes applied on the painful area lower leg.
Settings:
* Intensity up to patient tolerance.
* Duration 30min. Receives: Device: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure algometry:
Pain pressure algometry: Device to measure the intensity of painful stimuli objectively
Measured: Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks
The Brief Pain Inventory (BPI):
The Brief Pain Inventory (BPI): Is a multidimensional pain assessment tool used to evaluate pain severity and pain interference. The BPI has been translated and validity estimated across multiple languages and patient populations for clinical and research settings.
Measured: The Brief Pain Inventory (BPI): will be measured at baseline, and it will be measured again after eight weeks
Short form -36 questionnaire (KDQoL SF-36):
Short form -36 questionnaire (KDQoL SF-36): Is generic measure of health that has also been used widely in trials in hemodialysis patients for the objective measure quality of life
Measured: Short form -36 questionnaire (KDQoL SF-36):will be measured at baseline, and it will be measured again after eight weeks
Secondary outcomes (2)
The incremental shuttle walking test (ISWT):
The incremental shuttle walking test (ISWT):Is an important marker of aerobic capacity in patients on renal dialysis
Measured: The incremental shuttle walking test (ISWT):will be measured at baseline, and it will be measured again after eight weeks
Patient health questionnaire PHQ-9:
Patient health questionnaire PHQ-9: Is a nine-item questionnaire designed to screen depression in primary care and other medical settings
Measured: Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start28 Nov 2023
- Primary completion30 Jan 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed El-Moatasem Mohamed, Cairo University
- Investigators
- Hany Obaya, assistant professor, Principal investigator, giza, Egypt, 12511
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098443
- Sponsor's protocol ID
- P.T.REC/012/004482
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis
- ClinicalTrials.gov ID
- NCT06098443
- Acronym / sponsor ID
- P.T.REC/012/004482
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Hemodialysis patients have a high prevalence of pain, mainly musculoskeletal and intra dialytic pain. A high prevalence of pain was also observed in the upper and lower limbs and the trunk. In addition, severe functional interference of pain in the ability to walk was associated with pain in the upper Limb. These results indicate that pain in hemodialysis patients is limiting and disabling (Dos Santos et al., 2021).
Acupressure increases relaxation, relieves pain, and reduces anxiety and depression, especially in the elderly. It is relatively inexpensive, safe, non-invasive, and easy to use and is performed by hands, elbows. by applying pressure to specific areas of the body so muscle spasms are relieved, blood circulation and vital energy are improved (Bastani et al.,2022).
Strong non-painful TENS within or close to the site of pain produces clinically important reductions in the intensity of pain during or immediately after treatment. With no reports of serious adverse events. TENS as an adjunct to core treatment or immediate short-term relief of pain, irrespective of diagnosis. Patients should be advised to tailor TENS Treatment according to their individual needs (Johnson et al., 2022).
Detailed description
Sixty patients will be randomly assigned into two equal groups (n=30):
- Group A (30 patients) will receive Acupressure three times per week for eight weeks.
- Group B (30 patients) will receive TENS three times per week for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Other: AcupressureThe acupressure points will be determined, patients are informed that they will feel soft vibrations and pain during acupressure application. Patients are advised that it is sufficient for them to feel the vibrations of the acupressure device slightly. It be felt first symmetrically right knee, right leg, left knee, left leg Patients will receive acupressure 24 sessions three times a week for eight weeks. After application the patient will be asked about the severity of pain half an hour after administration (Çevik \& Taşcı, 2020). |
| Transcutaneous electrical nerve stimulation | Active comparator | Device: Transcutaneous electrical nerve stimulation• Placement electrodes applied on the painful area lower leg. Settings: * Intensity up to patient tolerance. * Duration 30min. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Sixty patients with renal failure stage 5 undergoing hemodialysis sessions at least six months ago up to 2 years.
Key exclusion criteria (10 listed)
- Skin disease such as dermatitis, stitches and wound.
- Active infection, autoimmune diseases and malignancy.
- Severe cardiac diseases.
- Severe chest diseases.
- Patients with cardiac pacemaker.
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 |
|---|---|---|
| AcupressureAcupressure is effective on anxiety and depression management. acupressure therapy at K1, ST36, and SP6 acupoints significantly reduced anxiety \& depression in patients with ESRD. | Other | Acupressure |
| Transcutaneous electrical nerve stimulationTENS lead to meaningful reduction of pain in patients suffering from difficult to treat phantom limb pain. This treatment has a high success rate and is associated with high satisfaction rates and no reported adverse events. The suggested duration of treatment is at least 30 minutes and may be extended up to 45 minutes. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extra segmental analgesia. TENS delivers pulsed electric currents across the intact surface of the skin to stimulate peripheral nerves and the spinal cord, resulting in segmental and extrasegmental analgesia. (Vathakul et al., 2022). | Device | Transcutaneous electrical nerve stimulation |
Primary outcome
Pain pressure algometry:
Time frame: Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks
Pain pressure algometry: Device to measure the intensity of painful stimuli objectively
The Brief Pain Inventory (BPI):
Time frame: The Brief Pain Inventory (BPI): will be measured at baseline, and it will be measured again after eight weeks
The Brief Pain Inventory (BPI): Is a multidimensional pain assessment tool used to evaluate pain severity and pain interference. The BPI has been translated and validity estimated across multiple languages and patient populations for clinical and research settings.
Short form -36 questionnaire (KDQoL SF-36):
Time frame: Short form -36 questionnaire (KDQoL SF-36):will be measured at baseline, and it will be measured again after eight weeks
Short form -36 questionnaire (KDQoL SF-36): Is generic measure of health that has also been used widely in trials in hemodialysis patients for the objective measure quality of life
2 secondary outcomes
The incremental shuttle walking test (ISWT):
Time frame: The incremental shuttle walking test (ISWT):will be measured at baseline, and it will be measured again after eight weeks
Patient health questionnaire PHQ-9:
Time frame: Patient health questionnaire PHQ-9:will be measured at baseline, and it will be measured again after eight weeks
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 13 May 2024.
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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.
Hany Obaya, assistant professor principal investigator
giza, Egypt, 12511
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Transcutaneous electrical nerve stimulation in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 10 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Pain pressure algometry: (time frame: Pain pressure algometry:will be measured at baseline, and it will be measured again after eight weeks). 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?
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 13 May 2024.