FibromyalgiaNCT04942444
Effectiveness of Dry Needling in Fibromyalgia Patients
A study testing Dry needling in people with Fibromyalgia and Chronic Pain, run by CEU San Pablo University at 1 site in Spain.
Trial summary
Patients with fibromyalgia (FM) complain of widespread chronic pain from deep tissues including muscles. Previous research highlights the relevance of impulse input from deep tissues for clinical FM pain. Deep dry needle stimulation is an invasive treatment modality used in the management of musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain, Anxiety
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2011to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had not responded to any of the previously used pharmacological and non-pharmacological treatments.
- Literate and able to complete the questionnaires and scales used in the study.
- Patients who accepted their inclusion in the trial signed the corresponding informed consent and were given an explanatory sheet of the project.
Who cannot join
- Patients with CNS involvement with or without treatment (stroke, Parkinson's, dementia, multiple sclerosis, etc.).
- Patients with inflammatory or autoimmune disease associated with Fibromyalgia.
- Patients with infectious, neoplastic disease, or parenteral drug use.
- Patients with insurmountable fear of needles
- Under 18 years of age
- Coagulation problems (including treatment with anticoagulants, due to the risk of bleeding).
Show all 11Show fewer
- Immunosuppressed people (due to the risk of infection),
- Lymphadenectomized people (due to the risk of lymphedema)
- Hypothyroidism (due to the risk of myxedema)
- Pregnant patients
- Patients with areas of the skin that present some type of wound, infection, macula or tattoo.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Paula Rivas
Segovia, ESSG, 40002
Paula Rivas, +34677204884, paula.rivascalvo@ceu.es
About this study
Official title: Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness
Patients with fibromyalgia (FM) complain of widespread chronic pain from deep tissues including muscles. Previous research highlights the relevance of impulse input from deep tissues for clinical FM pain. Deep dry needle stimulation is an invasive treatment modality used in the management of musculoskeletal pain. Its efficacy has been confirmed in the management of myofascial trigger points, so the purpose of the study is to determine if blocking abnormal impulse input with deep dry needling stimulation of tender point may decrease hyperalgesia, clinical pain and associated symptoms such as anxiety, depression, fatigue and improve the quality of life in FM patients.
Read the detailed description
Fibromyalgia (FM) is characterized by chronic widespread musculoskeletal pain that is often associated to other manifestations such as fatigue, sleep disturbances, anxiety and depression. FM diagnosis may be performed following the 1990 American College of Rheumatology (ACR) classification criteria that require a history of widespread pain for at least 3 months and tenderness in at least 11 of 18 defined tender points.
Dry needling is a broad term used to differentiate "non-injection" needling from the practice of "injection needling". In contrast to injection of an agent, dry needling utilizes a solid filament needle, as is used in the practice of acupuncture, and relies on the stimulation of specific reactions in the target tissue for its therapeutic effect. Is a relatively new treatment modality used by physicians and physical therapists worldwide as a part of complex treatment of chronic musculoskeletal pain. It is minimally invasive, cheap, easy to learn, and carries a low risk of complications. Its efficacy has been confirmed in numerous studies and systematic reviews on management of myofascial trigger points, acute and chronic low back pain, chronic lumbar myofascial trigger points, lumbar myofascial pain, chronic whiplash, and myofascial pain and headaches.
The clinical picture of FM suggests an increased activity and/or hypersensitivity in nociceptive pathways or inadequate activity in endogenous pain attenuation mechanisms. Administration of local injections of lidocaine in the tender points is considered a therapeutic approach in the management of FM and this therapy increases plasma concentrations of met-enkephalin. FM patients treated with dry needling also experience a rapid increase of plasma levels of met-enkephalin. Results derived from randomized clinical trials and systematic reviews disclosed no differences between injections of different substances and dry needling in the treatment of myofascial trigger points symptoms. These findings suggest that needling techniques may be effective in the management of FM.
Taken together all these considerations, the primary aim of this study is to investigate the efficacy of dry needling as a complementary treatment of severely affected FM patients. In addition, the investigators, aimed to establish whether this procedure might still yield some clinical improvement 6 weeks after the discontinuation of this intervention.
- Conditions
- Fibromyalgia, Chronic Pain, Anxiety, Depression, Fatigue, Sleep Disorder
- Being tested
- Dry needling
- Keywords
- dry needing
- Medical subject headings
- Fibromyalgia, Chronic Pain, Anxiety Disorders, Depression, Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
One-hour weekly session of DN in the 18th tender points during 6 weeks in the DNG, apart from continuing their medical treatment. The CG continue with the habitual medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients from the control group kept on taking the same medical treatment that they received before randomization |
| Dry needling group | Experimental | Besides maintaining their current medical treatment, patients from the experimental group received an additional weekly one-hour session of dry needling over the 18 tender points for a 6-week-period. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the score of pain.
- Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)
Measured: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in pain in using questionnaires
Fibromyalgia Impact Questionnaire (FIQ). Rank values from 0 (best outcome) to 100 (worst outcome)
Measured: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in the score of pain.
- Visual Analogue Scale (VAS). Rank values 0 (best outcome) to 10 (worst outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in pain in using questionnaires
McGill Pain Questionnaire (MPQ) The Pain Rating Index (PRI) score indices range from 0-78 based on the rank values of the chosen words. The value (score) associated with each descriptor is based on its position or rank order in the set of words, so that the first word receives a value of 1, the next a value of 2, and so on. Range values are summed within each subclass as well as in general. The PPI (Present pain intensity) ranges from 0-5. Scoring example: Temporal Group I: Periodic (1 point), Repetitive (2 points), Insistent (3 points), Endless (4 points). Each aspect that is assessed fits into four subscales: 1 to 10, sensitive subscale, 11 to 15, affective subscale; 16, evaluative subscale; 17 to 20, subscale of diverse aspects. Especially aimed at chronic pain.
Chronic Pain Acceptance Questionnaire (CPAQ)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in pain in using questionnaires
Chronic Pain Acceptance Questionnaire (CPAQ). Rank values from 0 (worst outcome) to 120 (best outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in pain in using questionnaires
Pain Catastrophizing Scale (PCS). Rank values from 0 (best outcome) to 52 (worst outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Secondary outcomes (9)
Changes in fatigue
- Six-minute walk test for the fatigue.
Measured: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in fatigue
Visual Analogue Scale of Fatigue (VAS). Rank value from 0 (best outcome) to 10 (worst outcome)
Measured: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in fatigue
Fatigue Severity Scale Questionnaire (FSS). Rank values from 0 (best outcome) to 63 (worst outcome)
Measured: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in anxiety
-Beck Anxiety Inventory (BAI). Rank values from 0 (best outcome) to 63 (worst outcome).
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in anxiety
- Visual Analogue Scale of Anxiety (VAS).Rank values from 0 (best outcome) to 10 (worst outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Depression
- Beck Depression Inventory (BDI). Rank values from 0 (best outcome) to 63 (worst outcome).
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Sleep
Pittsburgh Sleep Quality Index (PSQI). Rank values from 0 (best outcome) to 21 (worst outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Quality of Life
- Stanford Health Assessment Questionnaire (SHAQ). Rank values from 0 (best outcome) to 3 (worst outcome).
- Medical Outcomes Survey Short Form-36 (SF-36)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Quality of Life
- Medical Outcomes Survey Short Form-36 (SF-36). Rank values from 0 (worst outcome) to 100 (best outcome)
Measured: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Jan 2011
- Primary completion1 Feb 2011
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Rivas Calvo, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942444
- Sponsor's protocol ID
- CEU-0021
- Status last verified
- Jun 2021
- First submitted
- 21 Feb 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 2306288Kalichman 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.
PubMed 20823359Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.
PubMed 18395479Ceccherelli F, Rigoni MT, Gagliardi G, Ruzzante L. Comparison of superficial and deep acupuncture in the treatment of lumbar myofascial pain: a double-blind randomized controlled study. Clin J Pain. 2002 May-Jun;18(3):149-53. doi: 10.1097/00002508-200205000-00003.
PubMed 12048416Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
PubMed 12216605Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil. 1996 Nov;77(11):1161-6. doi: 10.1016/s0003-9993(96)90141-0.
PubMed 8931529Staud R. Is it all central sensitization? Role of peripheral tissue nociception in chronic musculoskeletal pain. Curr Rheumatol Rep. 2010 Dec;12(6):448-54. doi: 10.1007/s11926-010-0134-x.
PubMed 20882373Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.
PubMed 20544158Wallace DJ, Linker-Israeli M, Hallegua D, Silverman S, Silver D, Weisman MH. Cytokines play an aetiopathogenetic role in fibromyalgia: a hypothesis and pilot study. Rheumatology (Oxford). 2001 Jul;40(7):743-9. doi: 10.1093/rheumatology/40.7.743.
PubMed 11477278
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness
- ClinicalTrials.gov ID
- NCT04942444
- Acronym / sponsor ID
- CEU-0021
- Conditions
- Fibromyalgia, Chronic Pain, Anxiety, Depression, Fatigue, Sleep Disorder
- Keywords
- dry needing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2011 (actual)
- Primary completion
- 1 Feb 2011 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Jun 2021 (actual)
- 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.
Patients with fibromyalgia (FM) complain of widespread chronic pain from deep tissues including muscles. Previous research highlights the relevance of impulse input from deep tissues for clinical FM pain. Deep dry needle stimulation is an invasive treatment modality used in the management of musculoskeletal pain. Its efficacy has been confirmed in the management of myofascial trigger points, so the purpose of the study is to determine if blocking abnormal impulse input with deep dry needling stimulation of tender point may decrease hyperalgesia, clinical pain and associated symptoms such as anxiety, depression, fatigue and improve the quality of life in FM patients.
Detailed description
Fibromyalgia (FM) is characterized by chronic widespread musculoskeletal pain that is often associated to other manifestations such as fatigue, sleep disturbances, anxiety and depression. FM diagnosis may be performed following the 1990 American College of Rheumatology (ACR) classification criteria that require a history of widespread pain for at least 3 months and tenderness in at least 11 of 18 defined tender points.
Dry needling is a broad term used to differentiate "non-injection" needling from the practice of "injection needling". In contrast to injection of an agent, dry needling utilizes a solid filament needle, as is used in the practice of acupuncture, and relies on the stimulation of specific reactions in the target tissue for its therapeutic effect. Is a relatively new treatment modality used by physicians and physical therapists worldwide as a part of complex treatment of chronic musculoskeletal pain. It is minimally invasive, cheap, easy to learn, and carries a low risk of complications. Its efficacy has been confirmed in numerous studies and systematic reviews on management of myofascial trigger points, acute and chronic low back pain, chronic lumbar myofascial trigger points, lumbar myofascial pain, chronic whiplash, and myofascial pain and headaches.
The clinical picture of FM suggests an increased activity and/or hypersensitivity in nociceptive pathways or inadequate activity in endogenous pain attenuation mechanisms. Administration of local injections of lidocaine in the tender points is considered a therapeutic approach in the management of FM and this therapy increases plasma concentrations of met-enkephalin. FM patients treated with dry needling also experience a rapid increase of plasma levels of met-enkephalin. Results derived from randomized clinical trials and systematic reviews disclosed no differences between injections of different substances and dry needling in the treatment of myofascial trigger points symptoms. These findings suggest that needling techniques may be effective in the management of FM.
Taken together all these considerations, the primary aim of this study is to investigate the efficacy of dry needling as a complementary treatment of severely affected FM patients. In addition, the investigators, aimed to establish whether this procedure might still yield some clinical improvement 6 weeks after the discontinuation of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients from the control group kept on taking the same medical treatment that they received before randomization |
| Dry needling group | Experimental | Other: Dry needlingBesides maintaining their current medical treatment, patients from the experimental group received an additional weekly one-hour session of dry needling over the 18 tender points for a 6-week-period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who had not responded to any of the previously used pharmacological and non-pharmacological treatments.
- Literate and able to complete the questionnaires and scales used in the study.
- Patients who accepted their inclusion in the trial signed the corresponding informed consent and were given an explanatory sheet of the project.
Key exclusion criteria (11 listed)
- Patients with CNS involvement with or without treatment (stroke, Parkinson's, dementia, multiple sclerosis, etc.).
- Patients with inflammatory or autoimmune disease associated with Fibromyalgia.
- Patients with infectious, neoplastic disease, or parenteral drug use.
- Patients with insurmountable fear of needles
- Under 18 years of age
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 needlingOne-hour weekly session of DN in the 18th tender points during 6 weeks in the DNG, apart from continuing their medical treatment. The CG continue with the habitual medical treatment. | Other | Dry needling group |
Primary outcome
Changes in the score of pain.
Time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
- Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)
Changes in pain in using questionnaires
Time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Fibromyalgia Impact Questionnaire (FIQ). Rank values from 0 (best outcome) to 100 (worst outcome)
Changes in the score of pain.
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
- Visual Analogue Scale (VAS). Rank values 0 (best outcome) to 10 (worst outcome)
Changes in pain in using questionnaires
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
McGill Pain Questionnaire (MPQ) The Pain Rating Index (PRI) score indices range from 0-78 based on the rank values of the chosen words. The value (score) associated with each descriptor is based on its position or rank order in the set of words, so that the first word receives a value of 1, the next a value of 2, and so on. Range values are summed within each subclass as well as in general. The PPI (Present pain intensity) ranges from 0-5. Scoring example: Temporal Group I: Periodic (1 point), Repetitive (2 points), Insistent (3 points), Endless (4 points). Each aspect that is assessed fits into four subscales: 1 to 10, sensitive subscale, 11 to 15, affective subscale; 16, evaluative subscale; 17 to 20, subscale of diverse aspects. Especially aimed at chronic pain. Chronic Pain Acceptance Questionnaire (CPAQ)
Changes in pain in using questionnaires
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Chronic Pain Acceptance Questionnaire (CPAQ). Rank values from 0 (worst outcome) to 120 (best outcome)
Changes in pain in using questionnaires
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Pain Catastrophizing Scale (PCS). Rank values from 0 (best outcome) to 52 (worst outcome)
9 secondary outcomes
Changes in fatigue
Time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in fatigue
Time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in fatigue
Time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in anxiety
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in anxiety
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Depression
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Sleep
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Quality of Life
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Changes in Quality of Life
Time frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- 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 20823359Kalichman 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.
- Background: PubMed 18395479Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.
- Background: PubMed 12048416Ceccherelli F, Rigoni MT, Gagliardi G, Ruzzante L. Comparison of superficial and deep acupuncture in the treatment of lumbar myofascial pain: a double-blind randomized controlled study. Clin J Pain. 2002 May-Jun;18(3):149-53. doi: 10.1097/00002508-200205000-00003.
- Background: PubMed 12216605Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
- Background: PubMed 8931529Hong CZ, Hsueh TC. Difference in pain relief after trigger point injections in myofascial pain patients with and without fibromyalgia. Arch Phys Med Rehabil. 1996 Nov;77(11):1161-6. doi: 10.1016/s0003-9993(96)90141-0.
- Background: PubMed 20882373Staud R. Is it all central sensitization? Role of peripheral tissue nociception in chronic musculoskeletal pain. Curr Rheumatol Rep. 2010 Dec;12(6):448-54. doi: 10.1007/s11926-010-0134-x.
- Background: PubMed 20544158Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.
- Background: PubMed 11477278Wallace DJ, Linker-Israeli M, Hallegua D, Silverman S, Silver D, Weisman MH. Cytokines play an aetiopathogenetic role in fibromyalgia: a hypothesis and pilot study. Rheumatology (Oxford). 2001 Jul;40(7):743-9. doi: 10.1093/rheumatology/40.7.743.
- Individual participant dataSharing planned: No
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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.
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 in people with Fibromyalgia and Chronic Pain, run by CEU San Pablo University 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Rivas (+34677204884, paula.rivascalvo@ceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the score of pain. (time frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention)). The study lists 6 primary outcomes in all. 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 NCT04942444, which also lists 9 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 28 Jun 2021.