Effectiveness of Acupuncture Clinical Pathway

Chronic Pain Clinical Trial

— ACUPATHWAY  

Official title:

A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490798
• Other study ID #: ACUPATHWAY.R.1
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will be described the development and implementation of the Clinical pathway (CPW) for acupuncture treatment in the management of patients with some chronic pain conditions. The effectiveness of this CPW will be explored in this study through retrospective analysis of clinical outcomes after administration of acupuncture treatment summarised in the guidelines.

Description:

This longitudinal, observational, retrospective study included adults (>18 years) with common chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be a change in pain intensity measured by VAS for pain at the completion of treatment. Number of responder patients, reduction of pain medication intake, improve of quality of live scale, sleep quality index and scale of anxiety and depression after treatment are also to be included in the study. The purpose of this study is to assess the effectiveness of integrated a clinical pathway approach for chronic pain treatment with acupuncture in a Pain Clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3245
• Est. completion date: January 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Applying Acupuncture treatment Clinical Pathway and completed at least 50% of the medical appointments. Exclusion Criteria: Inclusion Criteria: Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Without applying Acupuncture treatment Clinical Pathway or not completed at least 50% of the medical appointments.

Related Conditions & MeSH terms

• Cervicalgia
• Chronic Pain
• Headache
• Low Back Pain
• Lumbar Back Pain
• Musculoskeletal Pain
• Neck Pain
• Osteoarthritis, Knee
• Shoulder Pain

Intervention

Procedure:
• Electroacupuncture
The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation.

Locations

Country	Name	City	State
Spain	Son Llatzer University Hospital	Palma	Balear Islands

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Llatzer

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9. — View Citation

Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6. — View Citation

Herman JP, Figueiredo H, Mueller NK, Ulrich-Lai Y, Ostrander MM, Choi DC, Cullinan WE. Central mechanisms of stress integration: hierarchical circuitry controlling hypothalamo-pituitary-adrenocortical responsiveness. Front Neuroendocrinol. 2003 Jul;24(3):151-80. Review. — View Citation

Hita-Contreras F, Martínez-López E, Latorre-Román PA, Garrido F, Santos MA, Martínez-Amat A. Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014 Jul;34(7):929-36. doi: 10.1007/s00296-014-2960-z. Epub 2014 Feb 8. — View Citation

Lawal AK, Rotter T, Kinsman L, Machotta A, Ronellenfitsch U, Scott SD, Goodridge D, Plishka C, Groot G. What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review. BMC Med. 2016 Feb 23;14:35. doi: 10.1186/s12916-016-0580-z. Review. — View Citation

Lee MS, Ernst E. Acupuncture for pain: an overview of Cochrane reviews. Chin J Integr Med. 2011 Mar;17(3):187-9. doi: 10.1007/s11655-011-0665-7. Epub 2011 Feb 27. Review. — View Citation

Lee SC, Yin SJ, Lee ML, Tsai WJ, Sim CB. Effects of acupuncture on serum cortisol level and dopamine beta-hydroxylase activity in normal Chinese. Am J Chin Med. 1982;10(1-4):62-9. — View Citation

Montón C, Pérez Echeverría MJ, Campos R, García Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish. — View Citation

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Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. — View Citation

Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish. — View Citation

Schneider A, Weiland C, Enck P, Joos S, Streitberger K, Maser-Gluth C, Zipfel S, Bagheri S, Herzog W, Friederich HC. Neuroendocrinological effects of acupuncture treatment in patients with irritable bowel syndrome. Complement Ther Med. 2007 Dec;15(4):255-63. Epub 2007 Feb 20. — View Citation

Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. Review. — View Citation

Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654. Review. — View Citation

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Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2. Review. — View Citation

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Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses. Ann N Y Acad Sci. 2009 Mar;1156:198-210. doi: 10.1111/j.1749-6632.2009.04424.x. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity measured by VAS for pain at the completion of treatment	Overall average pain intensity over the last month will be assessed by a continuous scale comprised of a horizontal line, anchored by 'no pain' (score of 0) and 'worst imaginable pain' (score of 100 (100 mm scale)	Baseline and after the completion of treatment at 4 months
Secondary	Number of responder patients to the acupuncture treatment.	Responders will be defined as patients with a reduction of pain scores of more than 30%, decreasing medication intake or improving quality of live scale (= 20%), sleep quality index (= 30%) following our Clinical Pathway.	Baseline, 1 month and after the completion of treatment at 4 months
Secondary	Reduction of pain medication intake after treatment	Analgesic medicine use will be obtained with a questionnaire elaborated according to the European Health Interview Survey (EUROHIS) recommendations. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ('Have you taken any pain medicine prescribed by your general practitioner?') as well as any medication not prescribed by their general practitioner ('Have you taken any pain medicine not prescribed by your general practitioner') and (2) whether their prescribed and non-prescribed pain medication use has increased or decreased.	Baseline, 1 month and after the completion of treatment at 4 months
Secondary	Improve of quality of live scale after treatment	Patient-related quality of live by SF-12 measured. The Spanish version validated by Schmidt S et al is used	Baseline, 1 month and after the completion of treatment at 4 months
Secondary	Improve sleep quality index after treatment	Measured with the Pittsburgh Sleep Quality Index (PSQ). The Spanish version validated by Hita-Contreras F et al is used	Baseline, 1 month and after the completion of treatment at 4 months
Secondary	Improve of scale of anxiety and depression after treatment	Levels of depression and anxiety will be measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al is used.	Baseline, 1 month and after the completion of treatment at 4 months

External Links

•   Wide-ranging online data for epidemiologic research (WONDER). , "Atlanta, GA: CDC, National Center for Health Statistics," 2016. [Online]. Available: http://wonder.cdc.gov.. [Accessed 7 july 2020].