Clinical trial NCT05130931: Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
Official title: Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion:

* 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.

Exclusion:

* 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.

Primary outcomes:
measure: Change in nocturnal symptoms intensity (VAS)
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in pain intensity (VAS)
timeFrame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
measure: Change in paresthesia intensity (VAS)
timeFrame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
measure: Change in BCTQ
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in DASH questionnaire
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
Secondary outcomes:
measure: Change in NRS
timeFrame: 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
measure: Change in Katz's Diagram
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in MOS Sleep Scale
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in SF-36
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in TSK
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in ULTT
timeFrame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
measure: Change in Strength
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in SWMT
timeFrame: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
measure: Change in Neuropen
timeFrame: Change between baseline, post-treatment, 3 months after, 6 months after
measure: Change in PGI-I
timeFrame: Change between post-treatment, 3 months after, 6 months after
Other outcomes:
measure: NCV
timeFrame: Baseline
Locations:
city: Zaragoza
country: Spain
facility: Faculty of Health of Science, University of Zaragoza
state: Aragón
Study officials:
References: