Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal Composition in Patients With Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Benefits of Dry Needling in Trigger Points on Autonomic Nervous System, Photoelectric Plethysmography, Body Composition in Patients With Fibromyalgia Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393352
• Other study ID #: UAL_435
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: October 30, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dru needling can be developed on active trigger points. Myofascial trigger points can be active or latent. An active myofascial trigger point pain causes giving a specific pathological picture. We will conduct a location of myofascial trigger points following the illustrations location myofascial trigger points that indicate Travell and Simons both left-sided and right.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Trigger Points

Intervention

Other:
• Dry Needling Therapy
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.
• Electrical Stimulation Therapy

Locations

Country	Name	City	State
Spain	Adelaida María Castro-Sánchez	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

Alonso-Blanco C, Fernández-de-Las-Peñas C, de-la-Llave-Rincón AI, Zarco-Moreno P, Galán-Del-Río 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. — View Citation

Alonso-Blanco C, Fernández-de-las-Peñas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-García 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. — View Citation

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. Review. — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha 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. — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha GA, Sánchez-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. — View Citation

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. Review. — View Citation

Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 2014 Apr 16;311(15):1570. doi: 10.1001/jama.2013.279453. — View Citation

Hidalgo-Lozano A, Fernández-de-las-Peñas C, Díaz-Rodríguez L, González-Iglesias J, Palacios-Ceña 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. — View Citation

Pastor Mira MÁ, Lledó Boyer A, López-Roig S, Pons Calatayud N, Martín-Aragón Gelabert M. [Predictors of healthcare resource use in fibromyalgia]. Psicothema. 2010 Nov;22(4):549-55. Spanish. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes Scores on Visual Analoge Scale	Intensity of pain (within McGill questionnaire)	At baseline and 4 weeks
Secondary	Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)	Cardiac output. Reflectivity index. Stiffness index. Oxygen saturation.	At baseline and 4 weeks
Secondary	Change Scores on Body Composition	Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.	At baseline and 4 weeks
Secondary	Changes Scores on Cholinergic response indicators (%).		At baseline and 4 weeks
Secondary	Changes Scores on Heart rate variability.		At baseline and 4 weeks
Secondary	Changes Scores on Valsalva ratio. K30/15.		At baseline and 4 weeks
Secondary	Changes Scores on Systemic vascular resistance.		At baseline and 4 weeks
Secondary	Changes Scores on Systolic pressure.		At baseline and 4 weeks
Secondary	Changes Scores on Diastolic pressure.		At baseline and 4 weeks
Secondary	Changes Scores on Assessment of autonomic nervous system	Galvanic response estimate.	At baseline and 4 weeks