- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380807
Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.
January 19, 2016 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria
Effects of Dry Needling on Posture, Spinal Mobility and Trigger Points on Spinal Muscles in Patients With Fibromyalgia Syndrome.
This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Almería, Spain, 04120
- Univesity of Almería
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dry Needling Therapy
Dry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.
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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".
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Active Comparator: Cross Tape Therapy
Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: up to Four Weeks
|
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
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up to Four Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with Trigger Points
Time Frame: up to Four Weeks
|
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.
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up to Four Weeks
|
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Posture and Spinal Mobility
Time Frame: up to Four Weeks
|
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.
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up to Four Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hannuksela M, Vaananen A. The sauna, skin and skin diseases. Ann Clin Res. 1988;20(4):276-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 28, 2015
First Submitted That Met QC Criteria
March 4, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 19, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAL- 423
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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