Effectiveness of Dry Needling in Fibromyalgia Patients

Depression Clinical Trial

Official title:

Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942444
• Other study ID #: CEU-0021
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2011
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2021
• Source: CEU San Pablo University
• Contact: Paula Rivas
• Phone: +34677204884
• Email: paula.rivascalvo[@]ceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2021
• Est. primary completion date: February 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Depression
• Fatigue
• Fibromyalgia
• Myofascial Pain Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Dry needling
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.

Locations

Country	Name	City	State
Spain	Paula Rivas	Segovia	Essg

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Baldry P. Superficial versus deep dry needling. Acupunct Med. 2002 Aug;20(2-3):78-81. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline measurements. Demographic variables.	- Material status	Baseline measurements were performed after eligibility (at week 0)
Other	Baseline measurements. Demographic variables.	- Employment status	Baseline measurements were performed after eligibility (at week 0)
Other	Baseline measurements. Demographic variables.	- Education status	Baseline measurements were performed after eligibility (at week 0)
Other	Baseline measurements. Demographic variables.	Years until disease diagnosis	Baseline measurements were performed after eligibility (at week 0)
Other	Baseline measurements. Demographic variables.	- Body mass index	Baseline measurements were performed after eligibility (at week 0)
Other	Baseline measurements. Demographic variables.	- Number of physical symptoms.	Baseline measurements were performed after eligibility (at week 0)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Changes in fatigue	- Six-minute walk test for the 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)
Secondary	Changes in fatigue	Visual Analogue Scale of Fatigue (VAS). Rank value from 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)
Secondary	Changes in fatigue	Fatigue Severity Scale Questionnaire (FSS). Rank values from 0 (best outcome) to 63 (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	Changes in anxiety	-Beck Anxiety Inventory (BAI). Rank values from 0 (best outcome) to 63 (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	Changes in anxiety	- Visual Analogue Scale of Anxiety (VAS).Rank values from 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)
Secondary	Changes in Depression	- Beck Depression Inventory (BDI). Rank values from 0 (best outcome) to 63 (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	Changes in Sleep	Pittsburgh Sleep Quality Index (PSQI). Rank values from 0 (best outcome) to 21 (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	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)	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	Changes in Quality of Life	- Medical Outcomes Survey Short Form-36 (SF-36). Rank values from 0 (worst outcome) to 100 (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)