NCT02380807

Brief Summary

This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

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

First Submitted

Initial submission to the registry

February 28, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

February 28, 2015

Last Update Submit

January 19, 2016

Conditions

Keywords

Paraspinal MusclesTrigger PointsRandomized Controlled TrialMobility Limitation

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

    up to Four Weeks

Secondary Outcomes (2)

  • Number of participants with Trigger Points

    up to Four Weeks

  • Posture and Spinal Mobility

    up to Four Weeks

Study Arms (2)

Dry Needling Therapy

EXPERIMENTAL

Dry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.

Device: Dry Needling

Cross Tape Therapy

ACTIVE COMPARATOR

Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension.

Other: Cross Tape Therapy

Interventions

Dry needling is the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, sometimes also known as intramuscular stimulation (IMS). Although dry needling originally utilized only hypodermic needles due to the concern that solid filiform needles had neither the strength or tactile feedback that hypodermic needles provided and that the solid filiform needle could be deflected by "dense contraction knots".

Dry Needling Therapy

The tape consists of cross bands or strips mesh cross, nonelastic and without any medication, forming a grid-shaped patch. The cross tape will be applied on trigger points.

Cross Tape Therapy

Eligibility Criteria

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

You may qualify if:

  • Fibromyalgia syndrome diagnosis.
  • Aged from 18 to 65 years.
  • No regular physical activity.
  • Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
  • Agreement to attend evening therapy sessions.

You may not qualify if:

  • Severe physical disability.
  • Comorbid conditions (eg, morbid obesity, inflammatory diseases, irritable bowel syndrome, interstitial cystitis).
  • Uncontrolled endocrine disorders (eg, hyperthyroidism or hypothyroidism, diabetes).
  • Malignancy.
  • Psychiatric.
  • Illnesses (eg, schizophrenia or substance abuse).
  • Medication usage other than as-needed analgesics (excluding long-term narcotics).
  • History of surgery.
  • History of whiplash injury.
  • Presence of a score \>9 points in the Beck Depression Inventory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity of AlmerĂ­a

AlmerĂ­a, AlmerĂ­a, 04120, Spain

Location

Related Publications (27)

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  • Castro-Sanchez AM, Garcia-Lopez H, Mataran-Penarrocha GA, Fernandez-Sanchez M, Fernandez-Sola C, Granero-Molina J, Aguilar-Ferrandiz ME. Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome. Pain Physician. 2017 Feb;20(2):37-52.

MeSH Terms

Conditions

FibromyalgiaBack PainMobility Limitation

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD (Lecturer)

Study Record Dates

First Submitted

February 28, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations