Effectiveness of Acupuncture Clinical Pathway (ACUPATHWAY)

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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain; Osteoarthritis, Knee; Shoulder Pain; Headache; Cervicalgia; Lumbar Back Pain
• Intervention / Treatment: Procedure: Electroacupuncture

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3245

Contacts and Locations

Study Locations

• Spain
  • Balear Islands
    • Palma, Balear Islands, Spain, 07198
      • Son LLatzer University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients (>18 years), who received acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), applying Acupuncture Treatment Clinical Pathway.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar back pain; Patients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway.	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.
Musculoskeletal pain; Patients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway.	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.
Cervicalgia; Patients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway.	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.
Knee osteoarthritis; Patients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway.	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.
Headache; Patients with headache treated following the Acupuncture Treatment Clinic Pathway.	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.
Shoulder pain; Patients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer
• Investigators: Principal Investigator: Javier Mata, MD, Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain

Publications and helpful links

General Publications

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
• 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.
• 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.
• Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
• 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.
• Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. doi: 10.1016/s0022-3999(02)00429-4.
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
• 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.
• Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.
• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. 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.
• 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.
• 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.
• Vickers AJ, Linde K. Acupuncture for chronic pain. JAMA. 2014 Mar 5;311(9):955-6. doi: 10.1001/jama.2013.285478.
• Camm AJ, Fox KAA. Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants. Open Heart. 2018 Apr 21;5(1):e000788. doi: 10.1136/openhrt-2018-000788. eCollection 2018.
• Nosikov A , Gudex C . eds. EUROHIS:, "Developing common instruments for health surveys. Amsterdam: IOS Press, 2003.".
• Monton C, Perez Echeverria MJ, Campos R, Garcia 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.
• Hita-Contreras F, Martinez-Lopez E, Latorre-Roman PA, Garrido F, Santos MA, Martinez-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.
• 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. doi: 10.1016/j.yfrne.2003.07.001.
• 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.
• 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. doi: 10.1142/S0192415X82000117.
• 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. doi: 10.1016/j.ctim.2006.12.002. Epub 2007 Feb 20.
• 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.

Helpful 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].

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: clinical pathway; acupuncture treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Arthralgia; Osteoarthritis; Back Pain; Low Back Pain; Osteoarthritis, Knee; Chronic Pain; Neck Pain; Shoulder Pain; Headache; Musculoskeletal Pain
• Other Study ID Numbers: ACUPATHWAY.R.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No