NCT02763332

Brief Summary

The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly expressed by the people who suffer from it is pain. The main goal of the present study is to analyse the effect of the kinesiotaping on the pain, comfort and postural position of the patient with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

May 3, 2016

Last Update Submit

June 24, 2016

Conditions

Fibromyalgia

Keywords

FibromyalgiaEfficacyTaping

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    The pain intensity was recorded by a visual analogue scale (VAS) of pain. The pain was expressed on a scale of 0-10, with 0 being "no pain" and 10 "maximum tolerable pain."

    three weeks

Secondary Outcomes (5)

  • Comfort.

    three weeks

  • Impact on quality of life.

    three weeks

  • Physical well-being

    three weeks

  • Trunk posture.

    three weeks

  • Perception of change

    three weeks

Study Arms (2)

Upper trunk group (UTG)

EXPERIMENTAL

In the UTG, the bandage was applied over the superior fibbers of the trapezious and levator scapulae muscle using a strip in a 'Y' shape. The individuals were asked to remain in an upright sitting position and the base of the strip was attached to the skin beyond the acromion without any tension. Later, we placed the two straps of the bandage with a range of tension from 15 to 25%. The main goal of this shape is achieve muscular relaxation of the trapezius, scapula levator and supraspinatus.

Other: Upper trunk group (UTG)

Global trunk group (GTG)

ACTIVE COMPARATOR

In the GTG the bandage was applied parallel to the paravertebral muscles in a 'C' shape. The individuals were sit in the same position with the head in the neutral position. The strip was pasted with approximately 25% of tension all over the paravertebral musculature. The main goal was procuring a global mechanical correction of the superior part of the trunk.

Other: Global trunk group (GTG)

Interventions

Upper trunk group (UTG)OTHER

This bandage was placed over the upper trapezius muscle.

Also known as: Upper trunk
Upper trunk group (UTG)
Global trunk group (GTG)OTHER

This bandage was placed globally along the back

Also known as: Global trunk
Global trunk group (GTG)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria (Wolfe et al., 2011). Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia.

You may not qualify if:

  • People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

  • Lim EC, Tay MG. Kinesio taping in musculoskeletal pain and disability that lasts for more than 4 weeks: is it time to peel off the tape and throw it out with the sweat? A systematic review with meta-analysis focused on pain and also methods of tape application. Br J Sports Med. 2015 Dec;49(24):1558-66. doi: 10.1136/bjsports-2014-094151. Epub 2015 Jan 16.

    PMID: 25595290RESULT

  • Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.

    PMID: 23306413RESULT

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Gemma Espí-López, PhD

    Faculty of Physiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

ES(1)