Effectiveness of Dry Needling in Fibromyalgia Patients

NCT04942444 | Unknown

• 1 other identifier: CEU-0021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Pain; Anxiety; Depression; Fatigue; Sleep Disorder

Keywords

dry needing

Outcome Measures

Primary Outcomes (6)

• Changes in the score of pain.

  \- Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)

  -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)

  -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)

  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)

  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)

  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)

  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

  -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

  -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

  -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

  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

  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 Outcomes (6)

• Baseline measurements. Demographic variables.

  Baseline measurements were performed after eligibility (at week 0)

• Baseline measurements. Demographic variables.

  Baseline measurements were performed after eligibility (at week 0)

• Baseline measurements. Demographic variables.

  Baseline measurements were performed after eligibility (at week 0)

Study Arms (2)

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.

Other: Dry needling

Interventions

Dry needling OTHER

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.

Dry needling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

Paula Rivas

Segovia, ESSG, 40002, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 2306288 BACKGROUND

• 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.

  PMID: 20823359 BACKGROUND

• 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.

  PMID: 18395479 BACKGROUND

• 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.

  PMID: 12048416 BACKGROUND

• Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. doi: 10.1136/aim.20.2-3.78.

  PMID: 12216605 BACKGROUND

• 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.

  PMID: 8931529 BACKGROUND

• 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.

  PMID: 20882373 BACKGROUND

• 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.

  PMID: 20544158 BACKGROUND

• 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.

  PMID: 11477278 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Anxiety Disorders; Depression; Fatigue; Sleep Wake Disorders

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Paula Rivas

CONTACT

+34677204884; paula.rivascalvo@ceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Colaborador Doctor Paula Rivas Calvo

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: June 28, 2021
• Study Start: January 10, 2011
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)