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Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome

NCT ID: NCT02611193

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

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Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS. Study design: Two-groups randomized single-blind interventional study.

Detailed Description

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Background: Carpal Tunnel Syndrome (CTS) is the most common compressive neuropathy in the upper limb. It considerably impairs patient's quality of life and generates important social consequences due to the lost of productivity and the cost of treatments. Both surgical and conservative treatment are utilized for CTS management. Manipulative treatment is a conservative, non-drug and cheap management option which can be proposed, but by now, treatment guidelines and reviews do not recommend it due to lack of evidence to assess his efficacy.

Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS.

Study design: Two-groups randomized single-blind interventional study. Methods: Sixty-six patients reporting CTS symptoms that are confirmed by clinical exam and nerve conduction studies will be included. Participants will be randomized in two arms, one receiving manipulative treatment and one receiving simulated manipulative treatment (1/week for 4 weeks). The main outcome measures will be the DASH questionnaire, the Boston Carpal Tunnel Syndrome Questionnaire, patient estimate on Visual Analog Scale for pain and the EuroQol-5D scale. All outcomes measures will be administrated to participants before the first manipulation, after the last session (4 weeks) and 12 weeks after the baseline measure.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Manipulative treatment

Manipulative Treatment

Group Type EXPERIMENTAL

Manipulative treatment

Intervention Type PROCEDURE

Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver

Simulated manipulative treatment

Simulated manipulative treatment

Group Type SHAM_COMPARATOR

Simulated manipulative treatment

Intervention Type PROCEDURE

Simulated Manipulative Treatment

Interventions

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Manipulative treatment

Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver

Intervention Type PROCEDURE

Simulated manipulative treatment

Simulated Manipulative Treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength
* Electromyography confirming CTS

Exclusion Criteria

* Previous surgical procedure for CTS in the same wrist
* Possible secondary CTS : hypothyroidism, diabetes mellitus, pregnancy, rheumatologic diseases, neck or shoulder complaints,
* Hand and wrist pathological conditions as previous disease, intervention, traumatism, anatomic abnormalities in shape or size.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Julio Domenech

MD-PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Schmitt, PM&RResident

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova, Valencia, Spain

Julio Domenech, MD-PhD

Role: STUDY_DIRECTOR

Hospital Arnau de Vilanova, Valencia, Spain

Central Contacts

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Julia Schmitt

Role: CONTACT

[email protected]

Other Identifiers

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MOM-STC

Identifier Type: -

Identifier Source: org_study_id