Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
- Conditions
- Carpal Tunnel Syndrome
- Registration Number
- NCT05130931
- Lead Sponsor
- Universidad de Zaragoza
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in paresthesia intensity (VAS) 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 pain intensity (VAS) 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 nocturnal symptoms intensity (VAS) 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 BCTQ 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 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.
- Secondary Outcome Measures
Name Time Method Change in Katz's Diagram Change between baseline, post-treatment, 3 months after, 6 months after 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.
Change in NRS 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 between baseline, post-treatment, 3 months after, 6 months after
Change in MOS Sleep Scale Change between baseline, post-treatment, 3 months after, 6 months after 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.
Change in TSK Change between baseline, post-treatment, 3 months after, 6 months after 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.
Change in ULTT Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after 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.
Change in SF-36 Change between baseline, post-treatment, 3 months after, 6 months after The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.
Change in PGI-I Change between post-treatment, 3 months after, 6 months after 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).
Change in Strength Change between baseline, post-treatment, 3 months after, 6 months after Pinch and grip strength were assessed by a manual dynamometer to evaluate forearm, hand and fingers muscle strength.
Change in SWMT Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after The Semmes-Weinstein monofilament test (SWMT) is a clinical widely used test to quantify the sensibility in patients with Carpal Tunnel Syndrome (CTS).
Change in Neuropen Change between baseline, post-treatment, 3 months after, 6 months after The Neuropen combines an interchangeable 10 g monofilament for cutaneous pressure assessment, and a calibrated sterile Neurotip for assessing pain sensation.
Trial Locations
- Locations (1)
Faculty of Health of Science, University of Zaragoza
🇪🇸Zaragoza, Aragón, Spain
Faculty of Health of Science, University of Zaragoza🇪🇸Zaragoza, Aragón, Spain