Carpal Tunnel SyndromeNCT05527743
Effectiveness of an Invasive Physical Therapy Protocol in Carpal Tunnel Syndrome: Randomized Controlled Clinical Trial
A study testing Invasive Physiotherapy in people with Carpal Tunnel Syndrome, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Invasive Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 1 Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or superior to 18 years old.
- Have a medical diagnosis of CTS, by a specialist of the Neurophysiology Service with confirmation of neurophysiological study, in any of its stages: mild, moderate or severe.
- Have access and be able (or have help) to use an online platform to conduct "meetings" with the health professional.
- Read the informed consent form and understand the objectives and conduct of the study.
Who cannot join
- Be pending compensation or litigation for health problems.
- Receiving physiotherapy treatment in the region in the month prior to the study.
- Present severe diseases that may be related to the clinical results: malignancy or history of cancer, tumors or fractures in the region to be treated, blood dyscrasia, severe trauma in the previous 3 months, surgery in the region in the previous 12 months.
- To present contraindications to the therapeutic approach such as Belanophobia (33).
- Subjects who have received any of the procedures under study (percutaneous neuromodulation or percutaneous electrolysis technique).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. It stands at 10% when following the criteria established by the National Institute for Occupational Safety and Health.
Within the prevalence, 1% are men and 7% women, with an incidence per year of 105 cases per 100,000 people. In 2019, the external consultant "statista" indicated that approximately 924,000 cases of CTS were registered in Spain. CTS generates large saturations in rehabilitation in primary care and in preoperative lists, for example, in 2008 there were 4,109 hospital admissions with a rate of 0.18 hospital discharges per thousand.
Read more
Risk factors for the development of CTS include female sex, older age, diabetes, menopause, hypothyroidism, obesity and pregnancy. Smoking appears to be a risk factor in the development of CTS. As well as wrist hyperflexion and hyperextension movements. The number of risk factors present progressively increases the prevalence of CTS.
CTS is characterized by the presence of neuropathic pain, nocturnal paresthesias and dysesthesia. It can be combined with loss of strength and atrophy of the tenar muscles. Therefore, the most severe cases produce very notable physical, psychological and economic consequences. For example, in the United States, CTS generates an annual primary care expenditure of $2 billion. Currently, the most recent clinical guidelines recommend the use of orthoses, exercises and manual therapy in the management of CTS, although there is no consensus on the most effective option. On the other hand, surgery is one of the most used therapeutic options. However, there is a great collapse of the health system and the waiting list for the intervention and it can take a long time.
The conservative therapeutic options used to date focus on the local approach to CTS at the wrist, and a recent systematic review has shown a high rate of surgical need (around 60%) at 3-year follow-up. This need for surgery may be reduced in the long term to 15% if the conservative approach includes maneuvers focused on desensitization of the central nervous system, performing an approach to the entire upper extremity. Current evidence suggests that CTS is a complex disorder, which presents sensitization mechanisms of the nervous system, and not only a peripheral nerve compression at the carpal tunnel level. Therefore, approaches and therapies with a central effect are hypothesized to be of future interest, in accordance with current nociceptive theories of CTS.
In the field of physiotherapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electrical current are applied through solid needles.
Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of the descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization.
Invasive electrolysis and neuromodulation techniques have been applied in other studies at the nerve level, especially in the sciatic nerve at the piriformis and hamstrings level, in the popliteal fossa and in the foot. However, there is no study performed in patients with CTS.
To date, there is no clear consensus on the therapeutic approach to CTS, and the application of these invasive physiotherapy techniques is a novel approach that encompasses the local effect of treatment by means of local ultrasound-guided insertion of the needle in the carpal tunnel and the central neurophysiological effect produced by the current when it is applied. Taking into account the good empirical results found in private clinics and the precedents of studies carried out in other nerves, this treatment approach for outpatient application in primary care centers could relieve the demand for hospital care for patients referred for surgical treatment.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. It stands at 10% when following the criteria established by the National Institute for Occupational Safety and Health.
Within the prevalence, 1% are men and 7% women, with an incidence per year of 105 cases per 100,000 people. In 2019, the external consultant "statista" indicated that approximately 924,000 cases of CTS were registered in Spain. CTS generates large saturations in rehabilitation in primary care and in preoperative lists, for example, in 2008 there were 4,109 hospital admissions with a rate of 0.18 hospital discharges per thousand.
Risk factors for the development of CTS include female sex, older age, diabetes, menopause, hypothyroidism, obesity and pregnancy. Smoking appears to be a risk factor in the development of CTS. As well as wrist hyperflexion and hyperextension movements. The number of risk factors present progressively increases the prevalence of CTS.
CTS is characterized by the presence of neuropathic pain, nocturnal paresthesias and dysesthesia. It can be combined with loss of strength and atrophy of the tenar muscles. Therefore, the most severe cases produce very notable physical, psychological and economic consequences. For example, in the United States, CTS generates an annual primary care expenditure of $2 billion. Currently, the most recent clinical guidelines recommend the use of orthoses, exercises and manual therapy in the management of CTS, although there is no consensus on the most effective option. On the other hand, surgery is one of the most used therapeutic options. However, there is a great collapse of the health system and the waiting list for the intervention and it can take a long time.
The conservative therapeutic options used to date focus on the local approach to CTS at the wrist, and a recent systematic review has shown a high rate of surgical need (around 60%) at 3-year follow-up. This need for surgery may be reduced in the long term to 15% if the conservative approach includes maneuvers focused on desensitization of the central nervous system, performing an approach to the entire upper extremity. Current evidence suggests that CTS is a complex disorder, which presents sensitization mechanisms of the nervous system, and not only a peripheral nerve compression at the carpal tunnel level. Therefore, approaches and therapies with a central effect are hypothesized to be of future interest, in accordance with current nociceptive theories of CTS.
In the field of physiotherapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electrical current are applied through solid needles.
Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of the descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization.
Invasive electrolysis and neuromodulation techniques have been applied in other studies at the nerve level, especially in the sciatic nerve at the piriformis and hamstrings level, in the popliteal fossa and in the foot. However, there is no study performed in patients with CTS.
To date, there is no clear consensus on the therapeutic approach to CTS, and the application of these invasive physiotherapy techniques is a novel approach that encompasses the local effect of treatment by means of local ultrasound-guided insertion of the needle in the carpal tunnel and the central neurophysiological effect produced by the current when it is applied. Taking into account the good empirical results found in private clinics and the precedents of studies carried out in other nerves, this treatment approach for outpatient application in primary care centers could relieve the demand for hospital care for patients referred for surgical treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Invasive Physiotherapy, Sham
- 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.
Invasive PhysiotherapyOther
They will receive an invasive physiotherapy protocol of 3 sessions of percutaneous electrolysis and percutaneous neuromodulation guided by ultrasound, with a time margin of one week between the first and the second session and two weeks between the second and the third. Each session will last approximately 30 minutes. Each treatment session will consist of the application of 3 impacts of 3 seconds of 1.5mA intensity (1.5:3:3) (34), in a needle placed in an echoguided manner in the carpal tunnel in relation to the median nerve over the area of fibrosis or entrapment. Subsequently, a second needle will be placed ultrasound-guided at the level of the elbow crease in relation to the median nerve. A symmetric biphasic current with a frequency of 2Hz and a pulse width of 250µs (22,35) will be applied for 17 minutes (36), increasing the intensity of the current until a slight tolerable discomfort is produced in relation to the patient's symptomatology.
ShamOther
The participants of the study corresponding to the sham group will receive the application of the transcutaneous electrical stimulation sham technique (37), placing the patches in the same points where the needles are located in the percutaneous electrolysis and percutaneous neuromodulation technique, remaining in the supine position for the necessary time after the technique is performed, until 30 minutes are completed, thus ensuring that the evaluator does not know to which group each patient has been assigned (37). This technique has been studied as a sham technique for electrolysis and neuromodulation interventions (37).
Once the study is completed and if the results are better in the IF group, the subjects in the sham group will be offered to receive this treatment. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of research.
| Study group | Role | What they receive |
|---|---|---|
| Invasive Physiotherapy | Experimental | Not described Receives: Other: Invasive Physiotherapy |
| Sham Group | Placebo comparator | Not described Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Present Pain Intensity (NPRS 0-10)
The intensity of hand pain will be recorded, using an 11-point numerical scale (NPRS) (0=no pain, 10=maximum pain). They will be asked for current pain. Because there is no value that determines the minimum clinically relevant difference in hand pain, a 2-point change, or 30% change, will be considered clinically relevant (38).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Pain Intensity in the previous week (NPRS 0-10)
The intensity of hand pain will be recorded, using an 11-point numerical scale (NPRS) (0=no pain, 10=maximum pain). They will be asked for the worst pain experienced in the previous week. Because there is no value that determines the minimum clinically relevant difference in hand pain, a 2-point change, or 30% change, will be considered clinically relevant (38).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Secondary outcomes (8)
Change in Neurophysiological study (m/s)
The procedures will be performed by a neurophysiologist with more than 10 years of clinical and research experience. The electrophysiological diagnostic criteria for CTS of the American Association of Neuromuscular and Electrodiagnostic Medicine (39) and the normal ranges of motor and sensory nerve conduction as described in the literature (40) will be used.
The degree of electrophysiological compromise present will be classified according to the Bland scale (41). The following will be taken as study variables: existence of denervation, distal motor latency of median nerve and ulnar nerve, distal sensory latency of median nerve and ulnar nerve, conduction velocity, action potential amplitude and sensory detail of both.
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in BOSTON questionnaire
Self-administered questionnaire designed to record symptom severity and functional status of patients with CTS (42). Higher scores are indicative of worse functional capacity and greater symptom severity. Minimally relevant clinical changes have been determined as 0.74 points for the function subscale and 1.14 points for the symptom severity subscale (43).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Global rating of change scale
Scale of global change perceived by the patient, designed to detect improvement or deterioration of the patient over time (44). An 11-point numerical scale (-7=evolving to much worse; +7=fully recovered). Considering +4 and +5 moderate positive changes and +6 and +7 notable changes (45).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Katz Diagram
Diagram for the localization of symptoms in the dorsal and palmar part of the hand, self-administered. The patient determines the location of his symptoms, determining them as pain, numbness, sensation of passing current or other. The diagnosis is considered as classic, probable, possible, or unlikely, according to Calfee (46).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Grip strength (Newtons)
A single measurement of grip strength will be performed, which has been shown to be more reliable than the average of 3 attempts (47), with the dynamometer (Baseline 12-0241 LITE) in Newtons. The patient will be seated with shoulder and wrist in neutral position and elbow at 90º of flexion (48).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Sensitivity (discrimination of two points)
The discrimination of two points on the palmar side of the 3rd target will be assessed, taking 6mm of distance as the normative value of discrimination of 2 points. Pressure will be applied with one or two points until causing some discomfort to the patient, having to discriminate if stimulated with 1 or 2 points, the minimum distance that manages to discriminate will be recorded (49).
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Sensitivity (Semmes-Weinstein Monofilament Test)
Stimulation by means of pressure filaments, seeking to detect the sensitive threshold by means of 1 second pressures, the necessary pressure will be applied to cause a slight deformation of the filament. The lightest filament detected (50) will be recorded.
Measured: Baseline; 1 month follow-up; 6 month follow-up
Change in Inhibitory modulation conditioned by pain (Kpa)
It will be performed with the aim of exploring the descending inhibitory pathway (51). The test of pain thresholds by pressure in the affected area is performed. A remote area, usually arm or hand, is subjected to a painful stimulus (ice cube) (52) or ischemia cuff (maximum 10 min at 200 mmHg or up to VAS 6). At that time, the pressure pain threshold test is repeated on the affected area. An increase in the value of the pressure threshold test will denote a correct functioning of the inhibitory modulation.
Measured: Baseline; 1 month follow-up; 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527743
- Sponsor's protocol ID
- CFC22STC
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borrella-Andres S, Rodriguez-Sanz J, Lopez-de-Celis C, Marques Garcia I, Bueno-Gracia E, Rodriguez-Mena D, Malo-Urries M. Effect of ultrasound-guided percutaneous electrolysis and nerve stimulation on pain and function in carpal tunnel syndrome: A randomized clinical trial. Pain Med. 2026 May 1;27(5):545-559. doi: 10.1093/pm/pnaf170.
PubMed 41528761
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Invasive Physical Therapy Protocol in Carpal Tunnel Syndrome: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05527743
- Acronym / sponsor ID
- CFC22STC
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Sep 2022 (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.
Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. It stands at 10% when following the criteria established by the National Institute for Occupational Safety and Health.
Within the prevalence, 1% are men and 7% women, with an incidence per year of 105 cases per 100,000 people. In 2019, the external consultant "statista" indicated that approximately 924,000 cases of CTS were registered in Spain. CTS generates large saturations in rehabilitation in primary care and in preoperative lists, for example, in 2008 there were 4,109 hospital admissions with a rate of 0.18 hospital discharges per thousand.
Risk factors for the development of CTS include female sex, older age, diabetes, menopause, hypothyroidism, obesity and pregnancy. Smoking appears to be a risk factor in the development of CTS. As well as wrist hyperflexion and hyperextension movements. The number of risk factors present progressively increases the prevalence of CTS.
CTS is characterized by the presence of neuropathic pain, nocturnal paresthesias and dysesthesia. It can be combined with loss of strength and atrophy of the tenar muscles. Therefore, the most severe cases produce very notable physical, psychological and economic consequences. For example, in the United States, CTS generates an annual primary care expenditure of $2 billion. Currently, the most recent clinical guidelines recommend the use of orthoses, exercises and manual therapy in the management of CTS, although there is no consensus on the most effective option. On the other hand, surgery is one of the most used therapeutic options. However, there is a great collapse of the health system and the waiting list for the intervention and it can take a long time.
The conservative therapeutic options used to date focus on the local approach to CTS at the wrist, and a recent systematic review has shown a high rate of surgical need (around 60%) at 3-year follow-up. This need for surgery may be reduced in the long term to 15% if the conservative approach includes maneuvers focused on desensitization of the central nervous system, performing an approach to the entire upper extremity. Current evidence suggests that CTS is a complex disorder, which presents sensitization mechanisms of the nervous system, and not only a peripheral nerve compression at the carpal tunnel level. Therefore, approaches and therapies with a central effect are hypothesized to be of future interest, in accordance with current nociceptive theories of CTS.
In the field of physiotherapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electrical current are applied through solid needles.
Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of the descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization.
Invasive electrolysis and neuromodulation techniques have been applied in other studies at the nerve level, especially in the sciatic nerve at the piriformis and hamstrings level, in the popliteal fossa and in the foot. However, there is no study performed in patients with CTS.
To date, there is no clear consensus on the therapeutic approach to CTS, and the application of these invasive physiotherapy techniques is a novel approach that encompasses the local effect of treatment by means of local ultrasound-guided insertion of the needle in the carpal tunnel and the central neurophysiological effect produced by the current when it is applied. Taking into account the good empirical results found in private clinics and the precedents of studies carried out in other nerves, this treatment approach for outpatient application in primary care centers could relieve the demand for hospital care for patients referred for surgical treatment.
Detailed description
Carpal Tunnel Syndrome (CTS) is the most common peripheral neuropathy due to entrapment, caused by compression of the median nerve as it passes under the transverse carpal ligament at the wrist. The prevalence of CTS is between 5% and 20% in the general population, according to the criteria used. It stands at 10% when following the criteria established by the National Institute for Occupational Safety and Health.
Within the prevalence, 1% are men and 7% women, with an incidence per year of 105 cases per 100,000 people. In 2019, the external consultant "statista" indicated that approximately 924,000 cases of CTS were registered in Spain. CTS generates large saturations in rehabilitation in primary care and in preoperative lists, for example, in 2008 there were 4,109 hospital admissions with a rate of 0.18 hospital discharges per thousand.
Risk factors for the development of CTS include female sex, older age, diabetes, menopause, hypothyroidism, obesity and pregnancy. Smoking appears to be a risk factor in the development of CTS. As well as wrist hyperflexion and hyperextension movements. The number of risk factors present progressively increases the prevalence of CTS.
CTS is characterized by the presence of neuropathic pain, nocturnal paresthesias and dysesthesia. It can be combined with loss of strength and atrophy of the tenar muscles. Therefore, the most severe cases produce very notable physical, psychological and economic consequences. For example, in the United States, CTS generates an annual primary care expenditure of $2 billion. Currently, the most recent clinical guidelines recommend the use of orthoses, exercises and manual therapy in the management of CTS, although there is no consensus on the most effective option. On the other hand, surgery is one of the most used therapeutic options. However, there is a great collapse of the health system and the waiting list for the intervention and it can take a long time.
The conservative therapeutic options used to date focus on the local approach to CTS at the wrist, and a recent systematic review has shown a high rate of surgical need (around 60%) at 3-year follow-up. This need for surgery may be reduced in the long term to 15% if the conservative approach includes maneuvers focused on desensitization of the central nervous system, performing an approach to the entire upper extremity. Current evidence suggests that CTS is a complex disorder, which presents sensitization mechanisms of the nervous system, and not only a peripheral nerve compression at the carpal tunnel level. Therefore, approaches and therapies with a central effect are hypothesized to be of future interest, in accordance with current nociceptive theories of CTS.
In the field of physiotherapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electrical current are applied through solid needles.
Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of the descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization.
Invasive electrolysis and neuromodulation techniques have been applied in other studies at the nerve level, especially in the sciatic nerve at the piriformis and hamstrings level, in the popliteal fossa and in the foot. However, there is no study performed in patients with CTS.
To date, there is no clear consensus on the therapeutic approach to CTS, and the application of these invasive physiotherapy techniques is a novel approach that encompasses the local effect of treatment by means of local ultrasound-guided insertion of the needle in the carpal tunnel and the central neurophysiological effect produced by the current when it is applied. Taking into account the good empirical results found in private clinics and the precedents of studies carried out in other nerves, this treatment approach for outpatient application in primary care centers could relieve the demand for hospital care for patients referred for surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive Physiotherapy | Experimental | Other: Invasive Physiotherapy |
| Sham Group | Placebo comparator | Other: Sham |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal or superior to 18 years old.
- Have a medical diagnosis of CTS, by a specialist of the Neurophysiology Service with confirmation of neurophysiological study, in any of its stages: mild, moderate or severe.
- Have access and be able (or have help) to use an online platform to conduct "meetings" with the health professional.
- Read the informed consent form and understand the objectives and conduct of the study.
Key exclusion criteria (5 listed)
- Be pending compensation or litigation for health problems.
- Receiving physiotherapy treatment in the region in the month prior to the study.
- Present severe diseases that may be related to the clinical results: malignancy or history of cancer, tumors or fractures in the region to be treated, blood dyscrasia, severe trauma in the previous 3 months, surgery in the region in the previous 12 months.
- To present contraindications to the therapeutic approach such as Belanophobia (33).
- Subjects who have received any of the procedures under study (percutaneous neuromodulation or percutaneous electrolysis technique).
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 |
|---|---|---|
| Invasive PhysiotherapyThey will receive an invasive physiotherapy protocol of 3 sessions of percutaneous electrolysis and percutaneous neuromodulation guided by ultrasound, with a time margin of one week between the first and the second session and two weeks between the second and the third. Each session will last approximately 30 minutes. Each treatment session will consist of the application of 3 impacts of 3 seconds of 1.5mA intensity (1.5:3:3) (34), in a needle placed in an echoguided manner in the carpal tunnel in relation to the median nerve over the area of fibrosis or entrapment. Subsequently, a second needle will be placed ultrasound-guided at the level of the elbow crease in relation to the median nerve. A symmetric biphasic current with a frequency of 2Hz and a pulse width of 250µs (22,35) will be applied for 17 minutes (36), increasing the intensity of the current until a slight tolerable discomfort is produced in relation to the patient's symptomatology. | Other | Invasive Physiotherapy |
| ShamThe participants of the study corresponding to the sham group will receive the application of the transcutaneous electrical stimulation sham technique (37), placing the patches in the same points where the needles are located in the percutaneous electrolysis and percutaneous neuromodulation technique, remaining in the supine position for the necessary time after the technique is performed, until 30 minutes are completed, thus ensuring that the evaluator does not know to which group each patient has been assigned (37). This technique has been studied as a sham technique for electrolysis and neuromodulation interventions (37). Once the study is completed and if the results are better in the IF group, the subjects in the sham group will be offered to receive this treatment. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of research. | Other | Sham Group |
Primary outcome
Change in Present Pain Intensity (NPRS 0-10)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
The intensity of hand pain will be recorded, using an 11-point numerical scale (NPRS) (0=no pain, 10=maximum pain). They will be asked for current pain. Because there is no value that determines the minimum clinically relevant difference in hand pain, a 2-point change, or 30% change, will be considered clinically relevant (38).
Change in Pain Intensity in the previous week (NPRS 0-10)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
The intensity of hand pain will be recorded, using an 11-point numerical scale (NPRS) (0=no pain, 10=maximum pain). They will be asked for the worst pain experienced in the previous week. Because there is no value that determines the minimum clinically relevant difference in hand pain, a 2-point change, or 30% change, will be considered clinically relevant (38).
8 secondary outcomes
Change in Neurophysiological study (m/s)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in BOSTON questionnaire
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Global rating of change scale
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Katz Diagram
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Grip strength (Newtons)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Sensitivity (discrimination of two points)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Sensitivity (Semmes-Weinstein Monofilament Test)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Change in Inhibitory modulation conditioned by pain (Kpa)
Time frame: Baseline; 1 month follow-up; 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 41528761Borrella-Andres S, Rodriguez-Sanz J, Lopez-de-Celis C, Marques Garcia I, Bueno-Gracia E, Rodriguez-Mena D, Malo-Urries M. Effect of ultrasound-guided percutaneous electrolysis and nerve stimulation on pain and function in carpal tunnel syndrome: A randomized clinical trial. Pain Med. 2026 May 1;27(5):545-559. doi: 10.1093/pm/pnaf170.
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive Physiotherapy in people with Carpal Tunnel Syndrome, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 4 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 2 Sep 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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 Jacobo Rodríguez-Sanz, PhD (+34 636136789, jrodriguezs@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Present Pain Intensity (NPRS 0-10) (time frame: Baseline; 1 month follow-up; 6 month follow-up). 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?
On the ClinicalTrials.gov record for NCT05527743, which also lists 1 linked publication.
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 2 Sep 2022.