Carpal Tunnel SyndromeNCT05130931
Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
A study testing Multimodal conservative treatment in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant. Systematic review shows that conservative treatment is effective for treatment of CTS. In Spain, most patients diagnosed by CTS are included in surgery list without considering conservative treatment as first option or providing… 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?
- Multimodal conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2021to 3 Feb 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Carpal Tunnel Syndrome (CTS) after the electrophysiological test at the neurophysiology service of the Miguel Servet Hospital in Zaragoza and be on the waiting list for CTS surgery.
- Have experienced symptoms for more than two months.
- Have sufficient comprehension and communication skills to communicate their symptoms and to fill in the questionnaires.
- Ability to maintain supine and lateral decubitus without causing symptoms or altering the patient's condition.
- Accept and give consent to participate voluntarily in the study.
Who cannot join
- Previous carpal tunnel surgery on the same limb.
- History of trauma on the upper limb which CTS may be associated, other musculoskeletal or neurological pathologies affecting the upper limb (e.g., cervical radiculopathy).
- Pregnancy, due to the influence of fluid retention in the cause of CTS, remitting spontaneously after childbirth, breastfeeding or up to 3 years after these episodes.
- Present physical contraindications (red flags) in general that contraindicate physical treatment such as: trauma, malignancy, inflammation, infection, fever... or psychological contraindications (yellow flags) that may have a marked effect on the results of treatment.
- Present specific physical contraindications that contraindicate diacutaneous fibrolysis treatment, such as ulcerations and skin alterations.
- Have specific contraindications that contraindicate surgical intervention such as taking anticoagulants or antiplatelet agents.
- Having received a steroid injection in the previous 6 months or interventions on the CTS in the previous 3 months.
- Pending trial or litigation related to CTS.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health of Science, University of Zaragoza
Zaragoza, Aragon, 50009
About this study
Official title: Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.
STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant. Systematic review shows that conservative treatment is effective for treatment of CTS. In Spain, most patients diagnosed by CTS are included in surgery list without considering conservative treatment as first option or providing drugs or night splint . However, surgical treatment is not always necessary for these patients, and waiting list delays can lead to aggravation of patients' symptoms.
Researches believe that performing a conservative treatment including diacutaneous fibrolysis on carpal tunnel syndrome patients, could reduce waiting surgery list, reduce the cost-effectiveness rate of the surgical process and improve patient's satisfaction and clinical findings. In addition, patients of any level of severity and with systemic pathology will be included to define which patients would benefit from surgical treatment and which from physiotherapeutic treatment.
Read more
The aim is to find out the impact of a multimodal physiotherapy treatment in patients with Carpal Tunnel Syndrome (CTS) on the patient and the Aragonese Health System.
A randomized controlled clinical trial will be performed. First a pilot study will be carried out. Patients with carpal tunnel syndrome included on waiting surgery list of Miguel Servet Hospital will be recruited. They will be randomized into a control group (staying in waiting list and performing healthcare standard) and into an experimental group (3 sessions of 45 min of diacutaneous fibrolysis and homebased treatment). Different outcomes will be assessed at pre-treatment, at the end of treatment, 3 and 6 months later.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Multimodal conservative treatment
- 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.
Multimodal conservative treatmentOther
15 min of Pain education + 20 min of Specific mobilization of the forearm musculature, pronator teres, tendons of the palmar flexors of the wrist and fingers, transverse carpal ligament and palmar fascia through manual mobilization assisted by Diacutaneous Fibrolysis technique + 10min of self-management and explanation of home-based exercise.
3 sessions of 45 minutes will be taken to perform this protocol and the patient will be shown a self-treatment to be performed 3-5 times a day. The protocol will be carried out over 3 weeks (1 session per week).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Conservative Treatment | Experimental | Not described Receives: Other: Multimodal conservative treatment |
| Standard healthcare. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nocturnal symptoms intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (nocturnal symptoms) orientated from the left (worst) to the right (best). Nocturnal sumptoms were measured in the last 3 days.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in pain intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). Pain was measured in the last 3 days and currently.
Measured: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in paresthesia intensity (VAS)
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (paresthesia) orientated from the left (worst) to the right (best). Paresthesia was measured in the last 3 days and currently.
Measured: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in BCTQ
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in DASH questionnaire
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Secondary outcomes (10)
Change in NRS
Change between baseline, post-treatment, 3 months after, 6 months after
Measured: The Numeric Rating Scale is a one-dimensional measure of symptoms intensity in adults. In our study, it was used to quantify the intensity of other symptoms present. It is a segmented numeric version of the visual analog scale (VAS) in which a respondent
Change in Katz's Diagram
Katz hand diagram is a drawing made by a patient of symptoms such as numbness, tingling, or pain affecting the hand and fingers. The drawing is a useful means of eliciting symptoms that suggest carpal tunnel syndrome.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in MOS Sleep Scale
The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in SF-36
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in TSK
The Tampa Scale of Kinesiophobia (TSK) is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in ULTT
The Upper Limb Tension Test is performed to assess mechanosensitivity of median nerve. Range of movement, symptom's location, symptoms response and structural differentiation were assessed.
Measured: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in Strength
Pinch and grip strength were assessed by a manual dynamometer to evaluate forearm, hand and fingers muscle strength.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in SWMT
The Semmes-Weinstein monofilament test (SWMT) is a clinical widely used test to quantify the sensibility in patients with Carpal Tunnel Syndrome (CTS).
Measured: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in Neuropen
The Neuropen combines an interchangeable 10 g monofilament for cutaneous pressure assessment, and a calibrated sterile Neurotip for assessing pain sensation.
Measured: Change between baseline, post-treatment, 3 months after, 6 months after
Change in PGI-I
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale).
Measured: Change between post-treatment, 3 months after, 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start12 May 2021
- Primary completion3 Nov 2022
- Study completion3 Feb 2023
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.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mar Hernández Secorún, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130931
- Sponsor's protocol ID
- MHS1
- Status last verified
- May 2023
- First submitted
- 29 Oct 2021
- Last updated
- 10 May 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.
- ClinicalTrials.gov ID
- NCT05130931
- Acronym / sponsor ID
- MHS1
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 23 Nov 2021 (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.
STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant. Systematic review shows that conservative treatment is effective for treatment of CTS. In Spain, most patients diagnosed by CTS are included in surgery list without considering conservative treatment as first option or providing drugs or night splint . However, surgical treatment is not always necessary for these patients, and waiting list delays can lead to aggravation of patients' symptoms.
Researches believe that performing a conservative treatment including diacutaneous fibrolysis on carpal tunnel syndrome patients, could reduce waiting surgery list, reduce the cost-effectiveness rate of the surgical process and improve patient's satisfaction and clinical findings. In addition, patients of any level of severity and with systemic pathology will be included to define which patients would benefit from surgical treatment and which from physiotherapeutic treatment.
The aim is to find out the impact of a multimodal physiotherapy treatment in patients with Carpal Tunnel Syndrome (CTS) on the patient and the Aragonese Health System.
A randomized controlled clinical trial will be performed. First a pilot study will be carried out. Patients with carpal tunnel syndrome included on waiting surgery list of Miguel Servet Hospital will be recruited. They will be randomized into a control group (staying in waiting list and performing healthcare standard) and into an experimental group (3 sessions of 45 min of diacutaneous fibrolysis and homebased treatment). Different outcomes will be assessed at pre-treatment, at the end of treatment, 3 and 6 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Conservative Treatment | Experimental | Other: Multimodal conservative treatment |
| Standard healthcare. | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with Carpal Tunnel Syndrome (CTS) after the electrophysiological test at the neurophysiology service of the Miguel Servet Hospital in Zaragoza and be on the waiting list for CTS surgery.
- Have experienced symptoms for more than two months.
- Have sufficient comprehension and communication skills to communicate their symptoms and to fill in the questionnaires.
- Ability to maintain supine and lateral decubitus without causing symptoms or altering the patient's condition.
- Accept and give consent to participate voluntarily in the study.
Key exclusion criteria (8 listed)
- Previous carpal tunnel surgery on the same limb.
- History of trauma on the upper limb which CTS may be associated, other musculoskeletal or neurological pathologies affecting the upper limb (e.g., cervical radiculopathy).
- Pregnancy, due to the influence of fluid retention in the cause of CTS, remitting spontaneously after childbirth, breastfeeding or up to 3 years after these episodes.
- Present physical contraindications (red flags) in general that contraindicate physical treatment such as: trauma, malignancy, inflammation, infection, fever... or psychological contraindications (yellow flags) that may have a marked effect on the results of treatment.
- Present specific physical contraindications that contraindicate diacutaneous fibrolysis treatment, such as ulcerations and skin alterations.
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 |
|---|---|---|
| Multimodal conservative treatment15 min of Pain education + 20 min of Specific mobilization of the forearm musculature, pronator teres, tendons of the palmar flexors of the wrist and fingers, transverse carpal ligament and palmar fascia through manual mobilization assisted by Diacutaneous Fibrolysis technique + 10min of self-management and explanation of home-based exercise. 3 sessions of 45 minutes will be taken to perform this protocol and the patient will be shown a self-treatment to be performed 3-5 times a day. The protocol will be carried out over 3 weeks (1 session per week). | Other | Multimodal Conservative Treatment |
Primary outcome
Change in nocturnal symptoms intensity (VAS)
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (nocturnal symptoms) orientated from the left (worst) to the right (best). Nocturnal sumptoms were measured in the last 3 days.
Change in pain intensity (VAS)
Time frame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). Pain was measured in the last 3 days and currently.
Change in paresthesia intensity (VAS)
Time frame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (paresthesia) orientated from the left (worst) to the right (best). Paresthesia was measured in the last 3 days and currently.
Change in BCTQ
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
Change in DASH questionnaire
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
10 secondary outcomes
Change in NRS
Time frame: The Numeric Rating Scale is a one-dimensional measure of symptoms intensity in adults. In our study, it was used to quantify the intensity of other symptoms present. It is a segmented numeric version of the visual analog scale (VAS) in which a respondent
Change in Katz's Diagram
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in MOS Sleep Scale
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in SF-36
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in TSK
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in ULTT
Time frame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in Strength
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in SWMT
Time frame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Change in Neuropen
Time frame: Change between baseline, post-treatment, 3 months after, 6 months after
Change in PGI-I
Time frame: Change between post-treatment, 3 months after, 6 months after
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 10 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal conservative treatment in people with Carpal Tunnel Syndrome, run by Universidad de Zaragoza 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 5 inclusion and 8 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 10 May 2023. 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. 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?
Change in nocturnal symptoms intensity (VAS) (time frame: Change between baseline, post-treatment, 3 months after, 6 months after). The study lists 5 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 10 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.