NCT02495298

Brief Summary

The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction, functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS). Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed. The study is blind for the patient and the raters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

July 8, 2015

Last Update Submit

October 3, 2016

Conditions

Carpal Tunnel Syndrome

Keywords

Fascial manipulationCarpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.

    Baseline and 10 days after end of the treatment.

Secondary Outcomes (4)

  • Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment.

    Baseline and 3 months after end of the treatment.

  • Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment.

    Baseline, 10 days and 3 months after the treatment

  • Change from baseline in function on DASH score for function at 10 days and 3

    Baseline, 10 days and 3 months after the treatment

  • Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment

    Baseline and 10 days after the treatment

Study Arms (2)

Treatment Fascial Manipulation

EXPERIMENTAL

Seven patients with diagnosis of CTS, received five sessions of Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.

Procedure: Fascial Manipulation

Placebo Fascial Manipulation

SHAM COMPARATOR

Seven patients with diagnosis of CTS, received five sessions of Sham Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.

Procedure: Sham Fascial Manipulation

Interventions

Fascial ManipulationPROCEDURE

The Fascial Manipulation was performed by a physiotherapist on the spots indicated by clinician as the most painful ones due to CTS. The selected spots were informed to the physiotherapist after the clinical anamnesis.

Treatment Fascial Manipulation
Sham Fascial ManipulationPROCEDURE

After the clinical anamnesis, a physiotherapist performed the Fascial Manipulation on different spots, rather than the spots the clinician considered the most painful ones due to CTS.

Placebo Fascial Manipulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CTS degrees Ia, Ib and II diagnosis according to clinical evaluation and electroneuromyography;
  • Wrist and finger paresthesia for more than 3 months prior to screening visit;
  • Moderate to intense pain: VAS\>4.
  • Ability to understand and respond to the questionnaires used in the trial;
  • Ability to understand the Informed Consent Form;
  • Sign the Informed Consent Form.

You may not qualify if:

  • Psychiatric disorders;
  • Fibromyalgia;
  • Rheumatologic diseases;
  • Other conditions related to CTS, as renal failure, diabetes, acromegaly, hyperthyroidism, multiple myeloma;
  • History of neoplasia;
  • History of surgery at Carpal Tunnel;
  • History of use of illegal drugs;
  • History of chronic use of corticosteroids;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Marta Imamura, MD

    Instituto de Medicina Física e Reabilitação HCFMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinator of the Clinical Trial Site of the Institute of Physical Medicine and Rehabilitation Medicine of HCFMUSP

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 13, 2015

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)