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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02380807
Other study ID # UAL- 423
Secondary ID
Status Completed
Phase N/A
First received February 28, 2015
Last updated January 19, 2016
Start date March 2015
Est. completion date July 2015

Study information

Verified date January 2016
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Dry Needling
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".
Other:
Cross Tape 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.

Locations

Country Name City State
Spain Univesity of Almería Almería

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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

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. — 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

Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère 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. — 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

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. — View Citation

Ge HY, Nie H, Madeleine P, Danneskiold-Samsøe 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. — View Citation

Ge HY, Wang Y, Danneskiold-Samsøe 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. — View 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. Review. — 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

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. Epub 2006 Mar 20. French. — View Citation

Hannuksela M, Väänänen A. The sauna, skin and skin diseases. Ann Clin Res. 1988;20(4):276-8. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — 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

Poulsen EU, Jørgensen JO, Madsen FF, Djurhuus JC. Cortical blood-flow in the porcine kidney. A radioactive microsphere study. Urol Res. 1988;16(5):385-7. — View 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. — View 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. Review. — 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 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. up to Four Weeks No
Secondary Number of participants with Trigger Points Dry Needly Therapy will be assesses in trigger points on trapezius muscle, supraspinatus muscle, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle. up to Four Weeks No
Secondary Posture and Spinal Mobility Spinal Mouse is a device that, combined with a computer program (PC), assesses the curvatures of the vertebral column without applying harmful radiation. Spinal Mouse checks: spine alignment, measuring segmental and global angles in the sagittal and frontal planes; posture and spinal mobility; and spine functions and performance. up to Four Weeks No
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