LymphedemaCDTNCT05932381
Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
A study testing Complete decongestive therapy and Medical treatment in people with Lymphedema, run by Cairo University.
Trial summary
this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Complete decongestive therapy and Medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2023to 5 Oct 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age will range between 20- 40 years.
- Only females will participate in the study.
- All patients have carpal tunnel syndrome post upper limb lymphedema.
Who cannot join
- Diabetes mellitus.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
- Sensory impairment.
About this study
this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.
Read the detailed description
lymphedema is a chronic condition characterized by lymphatic vessel ectasia and valve dysfunction, followed by the reflux of lymphatic fluid into the interstitial space. Lymph stasis may lead to a chronic inflammatory process, resulting in adipose tissue differentiation and fibro adipose tissue deposition. One consequence of post-mastectomy lymphedema may be the development of nerve entrapments. One example is median nerve entrapment in the carpal canal, or carpal tunnel syndrome (CTS). many studies assessed the relationship of CTS as a risk factor for developing lymphedema, other studies stated the possibility of lymphedema as a potential contributor to CTS development. Complex decongestive treatment of breast cancer-related lymphoedema is an accepted strategy and is considered as an international standard for treatment. A previous review concluded that complex decongestive therapy has a positive impact on the volume of arm and quality of life in different stages of lymphedema.sixty females will be allocated randomly to two groups; first one will receive decongestive therapy and the second one will receive the routine medical treatment for ten weeks
- Conditions
- Lymphedema
- Being tested
- Complete decongestive therapy, Medical treatment
- Keywords
- complete decongestive therapy, carpal tunnel syndrome, upper limb lymphedema
- Medical subject headings
- Lymphedema, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete decongestive therapyOther
the patients will receive Complete decongestive therapy in the form of intermittent pneumatic compression, Exercising, bandaging, and manual lymphatic drainage with Pressures of 50, 80, and 120 mmHg and timing 5, 20, and 50 secs
Medical treatmentOther
the patients will receive routine medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Complete decongestive therapy | Experimental | the patients will receive complete decongestive therapy twice a week for ten weeks Receives: Other: Complete decongestive therapy; Other: Medical treatment |
| medical treatment | Active comparator | the patients will receive routine medical treatment for ten weeks Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand strength
hand held dynamometer will be used for measuring the hand strength
Measured: up to ten weeks
median nerve conduction velocity
median nerve conduction velocity will be measured by electromyography device
Measured: up to ten weeks
Secondary outcomes (1)
pain intensity
Visual analogue scale which is 100 mm horizontal line will be used for measuring pain intensity. the scale has no pain on the left side and worst pain on the right side
Measured: up to ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start5 Jul 2023 (estimated)
- Primary completion5 Oct 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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
- Model description
- complete decongestive therapy and routine medical treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abd Elmohsen Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932381
- Sponsor's protocol ID
- P.T.REC/012/003738
- Acronym
- CDT
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
- ClinicalTrials.gov ID
- NCT05932381
- Acronym / sponsor ID
- CDT / P.T.REC/012/003738
- Conditions
- Lymphedema
- Keywords
- complete decongestive therapy, carpal tunnel syndrome, upper limb lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (estimated)
- Primary completion
- 5 Oct 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 6 Jul 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.
this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.
Detailed description
lymphedema is a chronic condition characterized by lymphatic vessel ectasia and valve dysfunction, followed by the reflux of lymphatic fluid into the interstitial space. Lymph stasis may lead to a chronic inflammatory process, resulting in adipose tissue differentiation and fibro adipose tissue deposition. One consequence of post-mastectomy lymphedema may be the development of nerve entrapments. One example is median nerve entrapment in the carpal canal, or carpal tunnel syndrome (CTS). many studies assessed the relationship of CTS as a risk factor for developing lymphedema, other studies stated the possibility of lymphedema as a potential contributor to CTS development. Complex decongestive treatment of breast cancer-related lymphoedema is an accepted strategy and is considered as an international standard for treatment. A previous review concluded that complex decongestive therapy has a positive impact on the volume of arm and quality of life in different stages of lymphedema.sixty females will be allocated randomly to two groups; first one will receive decongestive therapy and the second one will receive the routine medical treatment for ten weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- complete decongestive therapy and routine medical treatment
| Arm | Type | Receives |
|---|---|---|
| Complete decongestive therapy | Experimental | Other: Complete decongestive therapy, Other: Medical treatmentthe patients will receive complete decongestive therapy twice a week for ten weeks |
| medical treatment | Active comparator | Other: Medical treatmentthe patients will receive routine medical treatment for ten weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age will range between 20- 40 years.
- Only females will participate in the study.
- All patients have carpal tunnel syndrome post upper limb lymphedema.
Key exclusion criteria (5 listed)
- Diabetes mellitus.
- Individuals with cardiopulmonary conditions.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
- Sensory impairment.
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 |
|---|---|---|
| Complete decongestive therapythe patients will receive Complete decongestive therapy in the form of intermittent pneumatic compression, Exercising, bandaging, and manual lymphatic drainage with Pressures of 50, 80, and 120 mmHg and timing 5, 20, and 50 secs | Other | Complete decongestive therapy |
| Medical treatmentthe patients will receive routine medical treatment | Other | Complete decongestive therapy, medical treatment |
Primary outcome
hand strength
Time frame: up to ten weeks
hand held dynamometer will be used for measuring the hand strength
median nerve conduction velocity
Time frame: up to ten weeks
median nerve conduction velocity will be measured by electromyography device
1 secondary outcome
pain intensity
Time frame: up to ten weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Complete decongestive therapy and Medical treatment in people with Lymphedema, run by Cairo University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
hand strength (time frame: up to ten weeks). 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 6 Jul 2023.