Clinical trial NCT02380807: Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.
Official title: Effects of Dry Needling on Posture, Spinal Mobility and Trigger Points on Spinal Muscles in Patients With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Back Pain
Keywords: Paraspinal Muscles
Trigger Points
Randomized Controlled Trial
Mobility Limitation
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Dry Needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments. Dry needling (DN) is a technique used to treat dysfunctions in skeletal muscle, fascia, and connective tissue, and, diminish persistent peripheral nociceptive input, and reduce or restore impairments of body structure and function leading to improved activity and participation.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: up to Four Weeks
Secondary outcomes:
measure: Number of participants with Trigger Points
timeFrame: up to Four Weeks
measure: Posture and Spinal Mobility
timeFrame: up to Four Weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Univesity of Almería
Study officials:
References:
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.
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. doi: 10.1002/art.1780330203.
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.
citation: 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.
citation: Mas AJ, Carmona L, Valverde M, Ribas B; EPISER Study Group. Prevalence and impact of fibromyalgia on function and quality of life in individuals from the general population: results from a nationwide study in Spain. Clin Exp Rheumatol. 2008 Jul-Aug;26(4):519-26.
citation: Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: Ge HY, Nie H, Madeleine P, Danneskiold-Samsoe B, Graven-Nielsen T, Arendt-Nielsen L. Contribution of the local and referred pain from active myofascial trigger points in fibromyalgia syndrome. Pain. 2009 Dec 15;147(1-3):233-40. doi: 10.1016/j.pain.2009.09.019. Epub 2009 Oct 9.
citation: Ge HY, Wang Y, Danneskiold-Samsoe B, Graven-Nielsen T, Arendt-Nielsen L. The predetermined sites of examination for tender points in fibromyalgia syndrome are frequently associated with myofascial trigger points. J Pain. 2010 Jul;11(7):644-51. doi: 10.1016/j.jpain.2009.10.006. Epub 2009 Nov 14.
citation: Ge HY. Prevalence of myofascial trigger points in fibromyalgia: the overlap of two common problems. Curr Pain Headache Rep. 2010 Oct;14(5):339-45. doi: 10.1007/s11916-010-0127-5.
citation: Hannuksela M, Vaananen A. The sauna, skin and skin diseases. Ann Clin Res. 1988;20(4):276-8.
citation: Poulsen EU, Jorgensen JO, Madsen FF, Djurhuus JC. Cortical blood-flow in the porcine kidney. A radioactive microsphere study. Urol Res. 1988;16(5):385-7. doi: 10.1007/BF00256048.
citation: Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
citation: Vulfsons S, Ratmansky M, Kalichman L. Trigger point needling: techniques and outcome. Curr Pain Headache Rep. 2012 Oct;16(5):407-12. doi: 10.1007/s11916-012-0279-6.
citation: Lim C, Park Y, Bae Y. The effect of the kinesio taping and spiral taping on menstrual pain and premenstrual syndrome. J Phys Ther Sci. 2013 Jul;25(7):761-4. doi: 10.1589/jpts.25.761. Epub 2013 Aug 20.
citation: Fischer AA. Algometry in the daily practice of pain management. J Back Musculoskelet Rehabil. 1997 Jan 1;8(2):151-63. doi: 10.3233/BMR-1997-8209.
citation: Guermazi M, Ghroubi S, Kassis M, Jaziri O, Keskes H, Kessomtini W, Ben Hammouda I, Elleuch MH. [Validity and reliability of Spinal Mouse to assess lumbar flexion]. Ann Readapt Med Phys. 2006 May;49(4):172-7. doi: 10.1016/j.annrmp.2006.03.001. Epub 2006 Mar 20. French.
citation: Ripani M, Di Cesare A, Giombini A, Agnello L, Fagnani F, Pigozzi F. Spinal curvature: comparison of frontal measurements with the Spinal Mouse and radiographic assessment. J Sports Med Phys Fitness. 2008 Dec;48(4):488-94.
citation: Maarek A. Electro interstitial scan system: assessment of 10 years of research and development. Med Devices (Auckl). 2012;5:23-30. doi: 10.2147/MDER.S29319. Epub 2012 Mar 5.
citation: Alexeev VG, Kuznecova LV. Bioimpedance in monitoring of effects of selective serotonin reuptake inhibitor treatment. Psychol Res Behav Manag. 2011;4:81-6. doi: 10.2147/PRBM.S22925. Epub 2011 Jun 30.
citation: Lewis JE, Tannenbaum SL, Gao J, Melillo AB, Long EG, Alonso Y, Konefal J, Woolger JM, Leonard S, Singh PK, Chen L, Tiozzo E. Comparing the accuracy of ES-BC, EIS-GS, and ES Oxi on body composition, autonomic nervous system activity, and cardiac output to standardized assessments. Med Devices (Auckl). 2011;4:169-77. doi: 10.2147/MDER.S24291. Epub 2011 Sep 16.
citation: 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.