FibromyalgiaNCT02380807
Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.
A study testing Dry Needling and Cross Tape Therapy in people with Fibromyalgia and Back Pain, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Back Pain
- What is being tested?
- Dry Needling and Cross Tape Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia, Back Pain
- Being tested
- Dry Needling, Cross Tape Therapy
- Keywords
- Paraspinal Muscles, Trigger Points, Randomized Controlled Trial, Mobility Limitation
- Medical subject headings
- Fibromyalgia, Back Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
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".
Cross Tape TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Therapy | Experimental | Dry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle. Receives: Device: Dry Needling |
| Cross Tape Therapy | Active comparator | Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension. Receives: Other: Cross Tape Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Measured: up to Four Weeks
Secondary outcomes (2)
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.
Measured: up to Four Weeks
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.
Measured: up to Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380807
- Sponsor's protocol ID
- UAL- 423
- Status last verified
- Jan 2016
- First submitted
- 28 Feb 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20461783Wolfe 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.
PubMed 2306288Arnold 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.
PubMed 21531887Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 2014 Apr 16;311(15):1570. doi: 10.1001/jama.2013.279453. No abstract available.
PubMed 24737378Mas 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.
PubMed 18799079Branco 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.
PubMed 19250656Pastor 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.
PubMed 21044477Castro-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.
PubMed 21234327Giamberardino 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.
PubMed 21541831Affaitati 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.
PubMed 20889359Alonso-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.
PubMed 22935970Alonso-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.
PubMed 21368661Ge 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.
PubMed 19819074Ge 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.
PubMed 19914876Ge 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.
PubMed 20607459
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Posture, Spinal Mobility and Trigger Points on Spinal Muscles in Patients With Fibromyalgia Syndrome.
- ClinicalTrials.gov ID
- NCT02380807
- Acronym / sponsor ID
- UAL- 423
- Conditions
- Fibromyalgia, Back Pain
- Keywords
- Paraspinal Muscles, Trigger Points, Randomized Controlled Trial, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Therapy | Experimental | Device: Dry NeedlingDry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle. |
| Cross Tape Therapy | Active comparator | Other: Cross Tape TherapyCross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingDry 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". | Device | Dry Needling Therapy |
| Cross Tape TherapyThe 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. | Other | Cross Tape Therapy |
Primary outcome
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.
2 secondary outcomes
Number of participants with Trigger Points
Time frame: up to Four Weeks
Posture and Spinal Mobility
Time frame: up to Four Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Background: PubMed 20461783Wolfe 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.
- Background: PubMed 2306288Wolfe 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.
- Background: PubMed 21531887Arnold 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.
- Background: PubMed 24737378Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 2014 Apr 16;311(15):1570. doi: 10.1001/jama.2013.279453. No abstract available.
- Background: PubMed 18799079Mas 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.
- Background: PubMed 19250656Branco 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.
- Background: PubMed 21044477Pastor 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.
- Background: PubMed 21234327Castro-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.
- Background: PubMed 21541831Giamberardino 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.
- Background: PubMed 20889359Affaitati 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.
- Background: PubMed 22935970Alonso-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.
- Background: PubMed 21368661Alonso-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Cross Tape Therapy in people with Fibromyalgia and Back Pain, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: up to Four Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380807, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.