NCT02393352

Brief Summary

This study evaluates the benefits of dry needling in trigger points on autonomic nervous system, photoelectric plethysmography, body composition in patients with fibromyalgia syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

March 4, 2015

Last Update Submit

October 30, 2017

Conditions

FibromyalgiaTrigger Points

Keywords

Body CompositionAutonomic Nervous SystemOxygenRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Changes Scores on Visual Analoge Scale

    Intensity of pain (within McGill questionnaire)

    At baseline and 4 weeks

Secondary Outcomes (9)

  • Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)

    At baseline and 4 weeks

  • Change Scores on Body Composition

    At baseline and 4 weeks

  • Changes Scores on Cholinergic response indicators (%).

    At baseline and 4 weeks

  • Changes Scores on Heart rate variability.

    At baseline and 4 weeks

  • Changes Scores on Valsalva ratio. K30/15.

    At baseline and 4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Dry Needling Therapy

EXPERIMENTAL

The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.

Other: Dry Needling Therapy

Electrical Stimulation Therapy

ACTIVE COMPARATOR

Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration.

Other: Electrical Stimulation Therapy

Interventions

Dry Needling TherapyOTHER

The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.

Dry Needling Therapy
Electrical Stimulation TherapyOTHER
Electrical Stimulation 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)

Adelaida María Castro-Sánchez

Almería, 04120, Spain

Location

Related Publications (13)

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

    PMID: 20461783BACKGROUND

  • Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

    PMID: 2306288BACKGROUND

  • Arnold LM, Clauw DJ, McCarberg BH; FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011 May;86(5):457-64. doi: 10.4065/mcp.2010.0738.

    PMID: 21531887BACKGROUND

  • Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 2014 Apr 16;311(15):1570. doi: 10.1001/jama.2013.279453. No abstract available.

    PMID: 24737378BACKGROUND

  • Castro-Sanchez AM, Mataran-Penarrocha GA, Sanchez-Labraca N, Quesada-Rubio JM, Granero-Molina J, Moreno-Lorenzo C. A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. Clin Rehabil. 2011 Jan;25(1):25-35. doi: 10.1177/0269215510375909. Epub 2010 Aug 11.

    PMID: 20702514BACKGROUND

  • Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.

    PMID: 21943613BACKGROUND

  • Pastor Mira MA, Lledo Boyer A, Lopez-Roig S, Pons Calatayud N, Martin-Aragon Gelabert M. [Predictors of healthcare resource use in fibromyalgia]. Psicothema. 2010 Nov;22(4):549-55. Spanish.

    PMID: 21044477BACKGROUND

  • Castro-Sanchez AM, Mataran-Penarrocha GA, Granero-Molina J, Aguilera-Manrique G, Quesada-Rubio JM, Moreno-Lorenzo C. Benefits of massage-myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:561753. doi: 10.1155/2011/561753. Epub 2010 Dec 28.

    PMID: 21234327BACKGROUND

  • Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Effects of treatment of myofascial trigger points on the pain of fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):393-9. doi: 10.1007/s11916-011-0205-3.

    PMID: 21541831BACKGROUND

  • Affaitati G, Costantini R, Fabrizio A, Lapenna D, Tafuri E, Giamberardino MA. Effects of treatment of peripheral pain generators in fibromyalgia patients. Eur J Pain. 2011 Jan;15(1):61-9. doi: 10.1016/j.ejpain.2010.09.002.

    PMID: 20889359BACKGROUND

  • Alonso-Blanco C, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI, Zarco-Moreno P, Galan-Del-Rio F, Svensson P. Characteristics of referred muscle pain to the head from active trigger points in women with myofascial temporomandibular pain and fibromyalgia syndrome. J Headache Pain. 2012 Nov;13(8):625-37. doi: 10.1007/s10194-012-0477-y. Epub 2012 Aug 31.

    PMID: 22935970BACKGROUND

  • Alonso-Blanco C, Fernandez-de-las-Penas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-Garcia M. Multiple active myofascial trigger points reproduce the overall spontaneous pain pattern in women with fibromyalgia and are related to widespread mechanical hypersensitivity. Clin J Pain. 2011 Jun;27(5):405-13. doi: 10.1097/AJP.0b013e318210110a.

    PMID: 21368661BACKGROUND

  • Castro-Sanchez AM, Garcia-Lopez H, Fernandez-Sanchez M, Perez-Marmol JM, Leonard G, Gaudreault N, Aguilar-Ferrandiz ME, Mataran-Penarrocha GA. Benefits of dry needling of myofascial trigger points on autonomic function and photoelectric plethysmography in patients with fibromyalgia syndrome. Acupunct Med. 2020 Jun;38(3):140-149. doi: 10.1136/acupmed-2017-011504. Epub 2020 Jan 28.

    PMID: 31986897DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

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

March 4, 2015

First Posted

March 19, 2015

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

ES(1)