Carpal Tunnel SyndromeNCT04347746
Comparison of Interventions in Patients With Carpal Tunnel Syndrome
A study testing stretching physiotherapy and Myofascial therapy in people with Carpal Tunnel Syndrome and Carpal Tunnel Syndrome Bilateral, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
This study aims to compare two types of intervention (stretching and myofascial manipulation) in the treatment of individuals with bilateral idiopathic carpal tunnel syndrome. This comparison applies to two groups, the clinical group is composed of patients of mild or moderate degree, whereas the surgical group is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Bilateral
- What is being tested?
- stretching physiotherapy and Myofascial therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Sep 2019to 12 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral idiopathic CTS above six months of symptomatology;
- with clinical criteria and ENMG for indication of clinical or surgical treatment;
- who have no history of gabapentin allergy.
Who cannot join
- Individuals with CTS for other reasons, such as pregnancy, arthritis, hypothyroidism, diabetes mellitus, trauma, expansive tunnel damage, amyloids, sarcoidosis, multiple myeloma, and leukemia.
- Individuals with conditions that can simulate CTS, such as carpometacarpal thumb arthritis, cervical radiculopathy mainly of the sixth cervical root level, radial flexor carpal tenosynovitis and central disorders such as multiple sclerosis and cerebral infarction.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare two types of intervention (stretching and myofascial manipulation) in the treatment of individuals with bilateral idiopathic carpal tunnel syndrome. This comparison applies to two groups, the clinical group is composed of patients of mild or moderate degree, whereas the surgical group is composed of a patient with at least one hand in severe degree and interventions are made after surgery.
Read the detailed description
Using clinical criteria and ENMG, individuals will be divided into a clinical group when they have a mild and / or moderate degree of involvement in the hands and a surgical group when the impairment intensity is severe in at least one hand.
The individuals in the clinical group will be randomized into two groups, with one group starting with stretching and a second group starting with hook-assisted myofascial manipulation. After four weeks of initial therapy and one week of wash-out the assessment tests described above will be applied. The groups will be inverted, maintaining the duration and frequency of the previous stage of the proposed therapies. After four weeks with a week of wash-out the tests will be reapplied in order to evaluate the therapeutic response.
Individuals with severe idiopathic CTS will undergo surgery using a standard open technique with local anesthesia and after four weeks, randomization will be made for postoperative treatment on both hands by stretching or myofascial manipulation in the same manner described for the clinical group.
Questionnaires will be applied in order to understand the patient's symptoms, functions, pain and quality of life. In addition, tests will be used to assess hand strength, sensitivity and hand ability.
- Being tested
- stretching physiotherapy, Myofascial therapy
- 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.
stretching physiotherapyBehavioural
A booklet with images and a description of all movements to be performed during therapy will be offered to patients. The booklet illustrates the movements for stretching the upper limbs divided as follows: three movements for the neck, three movements for the arms and forearms and four movements for the hands.
The therapy will be carried out twice a week at the Unopar research center, under the guidance of a physiotherapist trained in technique and supervision by a senior therapist. At the end of each movement, the individual is instructed to maintain the position for 40 seconds.
Patients will be instructed to appear in comfortable clothes and the environment will have favorable conditions.
Myofascial therapyBehavioural
Myofascial therapy will be performed on the upper limbs, pectoral and dorsal regions with the aid of hooks (instrument assisted soft-tissue mobilization). In the supine position, the pectoral muscles will be manipulated (infracromial, external, axillary-claviculopectoral fossa), biceps brachii (short head, long and forearm insertion), round pronator, anterior forearm musculature (compartment of the radial extensor of the long carpus and brevis, finger extensor and ulnar carpal extensor). In lateral decubitus the deltoid muscle in the anterior, middle and posterior portions. In the prone position, the trapezius muscle (in its cervical, scapular and nuchal insertions), scapular levator muscle, great dorsal muscle (in its lateral insertions) and triceps brachii muscle. The hook manipulation time is two minutes of execution for each muscle mentioned above, making a total time of each section of forty minutes. There will be two weekly sessions with an interval between forty-eight hours.
| Study group | Role | What they receive |
|---|---|---|
| Clinical group | Active comparator | Individuals with bilateral idiopathic CTS with clinical criteria and mild to moderate ENMG severity and symptom evolution time above six months. Receives: Behavioral: stretching physiotherapy; Behavioral: Myofascial therapy |
| Surgical group | Active comparator | Individuals with bilateral idiopathic CTS with clinical criteria and severe ENMG in at least one hand and symptom evolution time above six months. These will be submitted to surgery on the severe hand and if equal severity on both hands, the dominant hand will be operated, with the patient's consent. Receives: Behavioral: stretching physiotherapy; Behavioral: Myofascial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Visual analog scale at eight weeks
The visual analog scale will measure the patient's pain intensity. The scale goes from 0 to 10, with 10 being better.
Measured: Change from baseline at 8 weeks
Change from baseline Boston Questionnarie score at eight weeks
The Boston questionnaire assesses the symptoms and functions of patients with CTS, it is self-administered. The sensitivity scale goes from 11 to 55, the motor scale goes from 7 to 35, bigger is better.
Measured: Change from baseline at 8 weeks
Secondary outcomes (6)
Change from baseline Short-Form 6 Dimensions at eight weeks
The Short-Form 6 Dimensions (SF6) questionnaire will be used to measure the impact on global health status. The scale goes from 0 to 100, with 100 being better.
Measured: Change from baseline at 8 weeks
Change from baseline Hand strength test at eight weeks
The hand strength test will use the Jammar hydraulic handgrip diameter and the hydraulic Pinch Gauge Jamar hydraulic will be used to measure the force of the digital clamp and digital clamp.
Measured: Change from baseline at 8 weeks.
Change from baseline Sensitivity tests at eigth weeks
The sensitivity tests will be evaluated with the Semmes-Weistein monofilaments on the distal digital pulp of the second and fifth fingers, the two-point discriminator Touch-Test on the distal digital pulp of the second and fifth fingers and the vibratory sensitivity with 30 and 259 hertz tuning fork over the distal interphalangeal joint of the second and fifth fingers.
Measured: Change from baseline at 8 weeks
Change from baseline Manual skill score at eigth weeks
Manual skill will be analyzed with the nine-pin box and manual skill panel
Measured: Change from baseline at 8 weeks
Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.
The BMHQ 12 items is an efficient and versatile result instrument, specific to manual disability and the quality of the therapeutic care employed. In addition, this questionnaire retains the psychometric properties of the original MHQ. The scale goes from 0 to 100, with 100 being better.
Measured: Change from baseline at 8 weeks
3D Assessment of Hand Function for the right and left hand.
3D assessement evaluates the hand in relation to pain, its function and its appearance from the perspective of the individual at the expense of the evaluation from the doctor's point of view.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start12 Sep 2019
- Primary completion12 Dec 2019
- Study completion12 Jun 2020
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347746
- Sponsor's protocol ID
- sg01
- Status last verified
- Nov 2020
- First submitted
- 19 Feb 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Interventions in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04347746
- Acronym / sponsor ID
- sg01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 15 Apr 2020 (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 aims to compare two types of intervention (stretching and myofascial manipulation) in the treatment of individuals with bilateral idiopathic carpal tunnel syndrome. This comparison applies to two groups, the clinical group is composed of patients of mild or moderate degree, whereas the surgical group is composed of a patient with at least one hand in severe degree and interventions are made after surgery.
Detailed description
Using clinical criteria and ENMG, individuals will be divided into a clinical group when they have a mild and / or moderate degree of involvement in the hands and a surgical group when the impairment intensity is severe in at least one hand.
The individuals in the clinical group will be randomized into two groups, with one group starting with stretching and a second group starting with hook-assisted myofascial manipulation. After four weeks of initial therapy and one week of wash-out the assessment tests described above will be applied. The groups will be inverted, maintaining the duration and frequency of the previous stage of the proposed therapies. After four weeks with a week of wash-out the tests will be reapplied in order to evaluate the therapeutic response.
Individuals with severe idiopathic CTS will undergo surgery using a standard open technique with local anesthesia and after four weeks, randomization will be made for postoperative treatment on both hands by stretching or myofascial manipulation in the same manner described for the clinical group.
Questionnaires will be applied in order to understand the patient's symptoms, functions, pain and quality of life. In addition, tests will be used to assess hand strength, sensitivity and hand ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical group | Active comparator | Behavioral: stretching physiotherapy, Behavioral: Myofascial therapyIndividuals with bilateral idiopathic CTS with clinical criteria and mild to moderate ENMG severity and symptom evolution time above six months. |
| Surgical group | Active comparator | Behavioral: stretching physiotherapy, Behavioral: Myofascial therapyIndividuals with bilateral idiopathic CTS with clinical criteria and severe ENMG in at least one hand and symptom evolution time above six months. These will be submitted to surgery on the severe hand and if equal severity on both hands, the dominant hand will be operated, with the patient's consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bilateral idiopathic CTS above six months of symptomatology;
- with clinical criteria and ENMG for indication of clinical or surgical treatment;
- who have no history of gabapentin allergy.
Key exclusion criteria (2 listed)
- Individuals with CTS for other reasons, such as pregnancy, arthritis, hypothyroidism, diabetes mellitus, trauma, expansive tunnel damage, amyloids, sarcoidosis, multiple myeloma, and leukemia.
- Individuals with conditions that can simulate CTS, such as carpometacarpal thumb arthritis, cervical radiculopathy mainly of the sixth cervical root level, radial flexor carpal tenosynovitis and central disorders such as multiple sclerosis and cerebral infarction.
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 |
|---|---|---|
| stretching physiotherapyA booklet with images and a description of all movements to be performed during therapy will be offered to patients. The booklet illustrates the movements for stretching the upper limbs divided as follows: three movements for the neck, three movements for the arms and forearms and four movements for the hands. The therapy will be carried out twice a week at the Unopar research center, under the guidance of a physiotherapist trained in technique and supervision by a senior therapist. At the end of each movement, the individual is instructed to maintain the position for 40 seconds. Patients will be instructed to appear in comfortable clothes and the environment will have favorable conditions. | Behavioural | Clinical group, Surgical group |
| Myofascial therapyMyofascial therapy will be performed on the upper limbs, pectoral and dorsal regions with the aid of hooks (instrument assisted soft-tissue mobilization). In the supine position, the pectoral muscles will be manipulated (infracromial, external, axillary-claviculopectoral fossa), biceps brachii (short head, long and forearm insertion), round pronator, anterior forearm musculature (compartment of the radial extensor of the long carpus and brevis, finger extensor and ulnar carpal extensor). In lateral decubitus the deltoid muscle in the anterior, middle and posterior portions. In the prone position, the trapezius muscle (in its cervical, scapular and nuchal insertions), scapular levator muscle, great dorsal muscle (in its lateral insertions) and triceps brachii muscle. The hook manipulation time is two minutes of execution for each muscle mentioned above, making a total time of each section of forty minutes. There will be two weekly sessions with an interval between forty-eight hours. | Behavioural | Clinical group, Surgical group |
Primary outcome
Change from baseline Visual analog scale at eight weeks
Time frame: Change from baseline at 8 weeks
The visual analog scale will measure the patient's pain intensity. The scale goes from 0 to 10, with 10 being better.
Change from baseline Boston Questionnarie score at eight weeks
Time frame: Change from baseline at 8 weeks
The Boston questionnaire assesses the symptoms and functions of patients with CTS, it is self-administered. The sensitivity scale goes from 11 to 55, the motor scale goes from 7 to 35, bigger is better.
6 secondary outcomes
Change from baseline Short-Form 6 Dimensions at eight weeks
Time frame: Change from baseline at 8 weeks
Change from baseline Hand strength test at eight weeks
Time frame: Change from baseline at 8 weeks.
Change from baseline Sensitivity tests at eigth weeks
Time frame: Change from baseline at 8 weeks
Change from baseline Manual skill score at eigth weeks
Time frame: Change from baseline at 8 weeks
Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.
Time frame: Change from baseline at 8 weeks
3D Assessment of Hand Function for the right and left hand.
Time frame: Day 0
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 27 Nov 2020.
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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 stretching physiotherapy and Myofascial therapy in people with Carpal Tunnel Syndrome and Carpal Tunnel Syndrome Bilateral, run by Universidade Norte do Paraná at 1 site in Brazil.
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 2 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 27 Nov 2020. 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 Brazil. 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 from baseline Visual analog scale at eight weeks (time frame: Change from baseline at 8 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 27 Nov 2020.