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

NCT05130931 | Completed

• 1 other identifier: MHS1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• 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 in Katz's Diagram

  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

• Change in SF-36

  Change between baseline, post-treatment, 3 months after, 6 months after

• Change in TSK

  Change between baseline, post-treatment, 3 months after, 6 months after

Other Outcomes (1)

• NCV

  Baseline

Study Arms (2)

Multimodal Conservative Treatment

EXPERIMENTAL

Other: Multimodal conservative treatment

Standard healthcare.

NO INTERVENTION

Interventions

Multimodal conservative treatment OTHER

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).

Multimodal Conservative Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Faculty of Health of Science, University of Zaragoza

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant and PhD student

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 23, 2021
• Study Start: May 12, 2021
• Primary Completion: November 3, 2022
• Study Completion: February 3, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

ES (1)