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Effectiveness of Dry Needling in Fibromyalgia Patients

Primary Purpose

Fibromyalgia, Chronic Pain, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring dry needing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Sites / Locations

  • Paula RivasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Dry needling group

Arm Description

Patients from the control group kept on taking the same medical treatment that they received before randomization

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.

Outcomes

Primary Outcome Measures

Changes in the score of pain.
- Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)
Changes in pain in using questionnaires
Fibromyalgia Impact Questionnaire (FIQ). Rank values from 0 (best outcome) to 100 (worst outcome)
Changes in the score of pain.
- Visual Analogue Scale (VAS). Rank values 0 (best outcome) to 10 (worst outcome)
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)
Changes in pain in using questionnaires
Chronic Pain Acceptance Questionnaire (CPAQ). Rank values from 0 (worst outcome) to 120 (best outcome)
Changes in pain in using questionnaires
Pain Catastrophizing Scale (PCS). Rank values from 0 (best outcome) to 52 (worst outcome)

Secondary Outcome Measures

Changes in fatigue
- Six-minute walk test for the fatigue.
Changes in fatigue
Visual Analogue Scale of Fatigue (VAS). Rank value from 0 (best outcome) to 10 (worst outcome)
Changes in fatigue
Fatigue Severity Scale Questionnaire (FSS). Rank values from 0 (best outcome) to 63 (worst outcome)
Changes in anxiety
-Beck Anxiety Inventory (BAI). Rank values from 0 (best outcome) to 63 (worst outcome).
Changes in anxiety
- Visual Analogue Scale of Anxiety (VAS).Rank values from 0 (best outcome) to 10 (worst outcome)
Changes in Depression
- Beck Depression Inventory (BDI). Rank values from 0 (best outcome) to 63 (worst outcome).
Changes in Sleep
Pittsburgh Sleep Quality Index (PSQI). Rank values from 0 (best outcome) to 21 (worst outcome)
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)
Changes in Quality of Life
- Medical Outcomes Survey Short Form-36 (SF-36). Rank values from 0 (worst outcome) to 100 (best outcome)

Full Information

First Posted
February 21, 2021
Last Updated
June 25, 2021
Sponsor
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT04942444
Brief Title
Effectiveness of Dry Needling in Fibromyalgia Patients
Official Title
Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2011 (Actual)
Primary Completion Date
February 1, 2011 (Actual)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain, Anxiety, Depression, Fatigue, Sleep Disorder
Keywords
dry needing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients from the control group kept on taking the same medical treatment that they received before randomization
Arm Title
Dry needling group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the score of pain.
Description
- Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)
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)
Title
Changes in pain in using questionnaires
Description
Fibromyalgia Impact Questionnaire (FIQ). Rank values from 0 (best outcome) to 100 (worst outcome)
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)
Title
Changes in the score of pain.
Description
- Visual Analogue Scale (VAS). Rank values 0 (best outcome) to 10 (worst outcome)
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)
Title
Changes in pain in using questionnaires
Description
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)
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)
Title
Changes in pain in using questionnaires
Description
Chronic Pain Acceptance Questionnaire (CPAQ). Rank values from 0 (worst outcome) to 120 (best outcome)
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)
Title
Changes in pain in using questionnaires
Description
Pain Catastrophizing Scale (PCS). Rank values from 0 (best outcome) to 52 (worst outcome)
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)
Secondary Outcome Measure Information:
Title
Changes in fatigue
Description
- Six-minute walk test for the 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)
Title
Changes in fatigue
Description
Visual Analogue Scale of Fatigue (VAS). Rank value from 0 (best outcome) to 10 (worst outcome)
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)
Title
Changes in fatigue
Description
Fatigue Severity Scale Questionnaire (FSS). Rank values from 0 (best outcome) to 63 (worst outcome)
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)
Title
Changes in anxiety
Description
-Beck Anxiety Inventory (BAI). Rank values from 0 (best outcome) to 63 (worst outcome).
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)
Title
Changes in anxiety
Description
- Visual Analogue Scale of Anxiety (VAS).Rank values from 0 (best outcome) to 10 (worst outcome)
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)
Title
Changes in Depression
Description
- Beck Depression Inventory (BDI). Rank values from 0 (best outcome) to 63 (worst outcome).
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)
Title
Changes in Sleep
Description
Pittsburgh Sleep Quality Index (PSQI). Rank values from 0 (best outcome) to 21 (worst outcome)
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)
Title
Changes in Quality of Life
Description
Stanford Health Assessment Questionnaire (SHAQ). Rank values from 0 (best outcome) to 3 (worst outcome). Medical Outcomes Survey Short Form-36 (SF-36)
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)
Title
Changes in Quality of Life
Description
- Medical Outcomes Survey Short Form-36 (SF-36). Rank values from 0 (worst outcome) to 100 (best outcome)
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)
Other Pre-specified Outcome Measures:
Title
Baseline measurements. Demographic variables.
Description
- Material status
Time Frame
Baseline measurements were performed after eligibility (at week 0)
Title
Baseline measurements. Demographic variables.
Description
- Employment status
Time Frame
Baseline measurements were performed after eligibility (at week 0)
Title
Baseline measurements. Demographic variables.
Description
- Education status
Time Frame
Baseline measurements were performed after eligibility (at week 0)
Title
Baseline measurements. Demographic variables.
Description
Years until disease diagnosis
Time Frame
Baseline measurements were performed after eligibility (at week 0)
Title
Baseline measurements. Demographic variables.
Description
- Body mass index
Time Frame
Baseline measurements were performed after eligibility (at week 0)
Title
Baseline measurements. Demographic variables.
Description
- Number of physical symptoms.
Time Frame
Baseline measurements were performed after eligibility (at week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Rivas
Phone
+34677204884
Email
paula.rivascalvo@ceu.es
Facility Information:
Facility Name
Paula Rivas
City
Segovia
State/Province
Essg
ZIP/Postal Code
40002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Rivas
Phone
+34677204884
Email
paula.rivascalvo@ceu.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2306288
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.
Results Reference
background
PubMed Identifier
20823359
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.
Results Reference
background
PubMed Identifier
18395479
Citation
Tough 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.
Results Reference
background
PubMed Identifier
12048416
Citation
Ceccherelli 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.
Results Reference
background
PubMed Identifier
12216605
Citation
Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.
Results Reference
background
PubMed Identifier
8931529
Citation
Hong 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.
Results Reference
background
PubMed Identifier
20882373
Citation
Staud 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.
Results Reference
background
PubMed Identifier
20544158
Citation
Srbely 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.
Results Reference
background
PubMed Identifier
11477278
Citation
Wallace 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.
Results Reference
background

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Effectiveness of Dry Needling in Fibromyalgia Patients

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