Carpal Tunnel SyndromeNCT06131515
Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
A study testing extra corporeal shock wave therapy device in people with Carpal Tunnel Syndrome, run by Cairo University at 2 sites in Egypt.
Trial summary
Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- extra corporeal shock wave therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2023to Dec 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants could be considered and enrolled if they conformed to the diagnosis of CTS, with clinical symptoms for at least 3 months.
- The clinical symptoms and signs for the diagnosis of CTS were as follows:
- Paresthesias and painful swelling with weakness of the affected hand, exacerbated while sleeping or by repetitive use of the wrist, which would be relieved by shaking the hand with postural change.
- Sensory loss with numbness in the regions of the hand innervated by the median nerve;
- Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
- Positive Tinel's sign.
Show all 11Show fewer
- The subject selection will be according to the following criteria:
- Female patient their age range between 40-60 years.
- Symptoms of CTS as pain, tingling sensation for at least 3 months.
- Unilateral or bilateral Lymphedema following mastectomy
- All patients enrolled to the study will have their informed consent.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Local infections at the hand level.
- Patients with prior medical histories of cardiac arrhythmias.
- Patient with venous thrombosis.
- Areas of skin with lesions and impaired sensation
- Other diseases that cause significant swelling.
- During pregnancy and breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Khadra Mohamed Ali
Cairo
shahira sami, A.lecturer, 01021986609, shahirasami6@cu.edu.eg
khadra mohamed ali, A.professor, 01098431152
- Recruiting
Shahira Sami
Cairo
shahira sami, A.lecturer, 01021986609, shahirasami6@cu.edu.eg
khadra mohamed ali, A.professor, 01098431152
About this study
Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. The participants will be selected from Out Patient clinic of Faculty of Physical Therapy, Cairo University and randomly distributed into two equal groups.Duration of treatment for 4weeks.All subjects signed an informed consent form, and the rights of subjects were protected.
Read the detailed description
In this study the patients will be randomly assigned into two equal groups(34 patients for each group)Group A (experimental group):This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Group B (control group):
This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- extra corporeal shock wave therapy device
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra corporeal shock wave therapy deviceDevice
Patients were seated in a relaxed position with their forearm and finger placed on the table. The median nerve was identified at the pisiform level of the proximal carpal tunnel, with the palm facing upwards. rESWT was delivered with the Physio Shock Wave Therapy system .The rESWT probe was located and oriented perpendicularly on the median nerve, and treatment comprised graduated shots at a bar pressure of 4 and a pulse repetition frequency of 5Hz for each patient ( The treated area was parallel to the median nerve from the pisiform level to 2 cm proximal to the inlet of the carpal tunnel with equal diffusion of 800, 900, 1000, 1100 shots from first to fourth session respectively. The procedure was painless, and there was no need for additional anesthesia or analgesia.
In the control group, sham rESWT just made the same sound without energy emission
| Study group | Role | What they receive |
|---|---|---|
| Group A (experimental group) | Experimental | This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Receives: Device: extra corporeal shock wave therapy device |
| Group B (control group) | Experimental | This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks. Receives: Device: extra corporeal shock wave therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction studies
For assessing the motor response, the recorder electrode on abductor pollicis brevis muscle and median nerve was stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode , and the distal latency was recorded. Regarding the sensory response, the recorder was fastened on the third finger, and stimulator electrode was placed 14 cm proximal to the recorder and stimulated median nerve at wrist and at palm region, then distal latency was recorded. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of APB, it was moderate CTS
Measured: 4weeks
Limb volume
Upper limb volumes were calculated from circumference measurements taken at 5cm intervals from the dorsum of the wrist to the axilla. Volume was calculated from circumference using the established formula
Measured: 4weeks
Visual analogue scale (VAS)
The VAS uses a straight 10-centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level within the last 24 hours.
Measured: 4weeks
Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ is used to evaluate symptom severity and dysfunction in patients with CTS .It contains 2 measurement scales: a symptom severity scale (BCTQ-S) and a functional status scale (BCTQ-F). The BCTQ-S uses 11 questions to evaluate the intensity and frequency of pain, numbness, weakness and loss of dexterity on a five-point scale ranging from 1 (no symptoms) to 5 (severe symptoms). The results are interpreted as the average scores of the 11 questions. The BCTQ-F has 8 questions to evaluate the level of difficulty in performing daily tasks, each rated on a five-point scale ranging from 1 (no difficulty) to 5 (cannot do at all due to hand or wrist symptoms). The results are interpreted as the average scores of the 8 questions
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahira Sami, Cairo University
- Investigators
- shahira sami, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131515
- Sponsor's protocol ID
- 1582017
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after 6months we will share the study protocol and informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT06131515
- Acronym / sponsor ID
- 1582017
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Nov 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.
Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. The participants will be selected from Out Patient clinic of Faculty of Physical Therapy, Cairo University and randomly distributed into two equal groups.Duration of treatment for 4weeks.All subjects signed an informed consent form, and the rights of subjects were protected.
Detailed description
In this study the patients will be randomly assigned into two equal groups(34 patients for each group)Group A (experimental group):This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Group B (control group):
This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (experimental group) | Experimental | Device: extra corporeal shock wave therapy deviceThis group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. |
| Group B (control group) | Experimental | Device: extra corporeal shock wave therapy deviceThis group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- All participants could be considered and enrolled if they conformed to the diagnosis of CTS, with clinical symptoms for at least 3 months.
- Paresthesias and painful swelling with weakness of the affected hand, exacerbated while sleeping or by repetitive use of the wrist, which would be relieved by shaking the hand with postural change.
- Sensory loss with numbness in the regions of the hand innervated by the median nerve;
- Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
- Positive Tinel's sign.
Key exclusion criteria (7 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- Local infections at the hand level.
- Patients with prior medical histories of cardiac arrhythmias.
- Patient with venous thrombosis.
- Areas of skin with lesions and impaired sensation
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 |
|---|---|---|
| extra corporeal shock wave therapy devicePatients were seated in a relaxed position with their forearm and finger placed on the table. The median nerve was identified at the pisiform level of the proximal carpal tunnel, with the palm facing upwards. rESWT was delivered with the Physio Shock Wave Therapy system .The rESWT probe was located and oriented perpendicularly on the median nerve, and treatment comprised graduated shots at a bar pressure of 4 and a pulse repetition frequency of 5Hz for each patient ( The treated area was parallel to the median nerve from the pisiform level to 2 cm proximal to the inlet of the carpal tunnel with equal diffusion of 800, 900, 1000, 1100 shots from first to fourth session respectively. The procedure was painless, and there was no need for additional anesthesia or analgesia. In the control group, sham rESWT just made the same sound without energy emission | Device | Group A (experimental group), Group B (control group) |
Primary outcome
Nerve conduction studies
Time frame: 4weeks
For assessing the motor response, the recorder electrode on abductor pollicis brevis muscle and median nerve was stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode , and the distal latency was recorded. Regarding the sensory response, the recorder was fastened on the third finger, and stimulator electrode was placed 14 cm proximal to the recorder and stimulated median nerve at wrist and at palm region, then distal latency was recorded. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of APB, it was moderate CTS
Limb volume
Time frame: 4weeks
Upper limb volumes were calculated from circumference measurements taken at 5cm intervals from the dorsum of the wrist to the axilla. Volume was calculated from circumference using the established formula
Visual analogue scale (VAS)
Time frame: 4weeks
The VAS uses a straight 10-centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level within the last 24 hours.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: 4weeks
The BCTQ is used to evaluate symptom severity and dysfunction in patients with CTS .It contains 2 measurement scales: a symptom severity scale (BCTQ-S) and a functional status scale (BCTQ-F). The BCTQ-S uses 11 questions to evaluate the intensity and frequency of pain, numbness, weakness and loss of dexterity on a five-point scale ranging from 1 (no symptoms) to 5 (severe symptoms). The results are interpreted as the average scores of the 11 questions. The BCTQ-F has 8 questions to evaluate the level of difficulty in performing daily tasks, each rated on a five-point scale ranging from 1 (no difficulty) to 5 (cannot do at all due to hand or wrist symptoms). The results are interpreted as the average scores of the 8 questions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Yes. after 6months we will share the study protocol and informed consent.
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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.
shahira sami principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra corporeal shock wave therapy device in people with Carpal Tunnel Syndrome, run by Cairo University at 2 sites 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 11 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shahira sami, A.lecturer (01021986609, shahirasami6@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction studies (time frame: 4weeks). The study lists 4 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 15 Nov 2023.