Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.

Carpal Tunnel Syndrome Clinical Trial

Official title:

Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130931
• Other study ID #: MHS1
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: February 3, 2023

Study information

• Verified date: May 2023
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 3, 2023
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Multimodal conservative treatment
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).

Locations

Country	Name	City	State
Spain	Faculty of Health of Science, University of Zaragoza	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NCV	Neural conduction velocity (NCV) test is used to assess nerve damage and dysfunction. It allows classification of the severity of the patient's dysfunction on mild, moderate or severe.	Baseline
Primary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Primary	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.	Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Primary	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.	Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Primary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Primary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	Change in NRS	Change between baseline, post-treatment, 3 months after, 6 months after	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
Secondary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	Change in SF-36	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	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.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	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.	Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Secondary	Change in Strength	Pinch and grip strength were assessed by a manual dynamometer to evaluate forearm, hand and fingers muscle strength.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	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).	Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
Secondary	Change in Neuropen	The Neuropen combines an interchangeable 10 g monofilament for cutaneous pressure assessment, and a calibrated sterile Neurotip for assessing pain sensation.	Change between baseline, post-treatment, 3 months after, 6 months after
Secondary	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).	Change between post-treatment, 3 months after, 6 months after