Clinical trial NCT04490798: Effectiveness of Acupuncture Clinical Pathway
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lumbar Back Pain
Osteoarthritis, Knee
Headache
Shoulder Pain
Cervicalgia
Musculoskeletal Pain
Keywords: acupuncture treatment
clinical pathway
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 3245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity measured by VAS for pain at the completion of treatment
timeFrame: Baseline and after the completion of treatment at 4 months
Secondary outcomes:
measure: Number of responder patients to the acupuncture treatment.
timeFrame: Baseline, 1 month and after the completion of treatment at 4 months
measure: Reduction of pain medication intake after treatment
timeFrame: Baseline, 1 month and after the completion of treatment at 4 months
measure: Improve of quality of live scale after treatment
timeFrame: Baseline, 1 month and after the completion of treatment at 4 months
measure: Improve sleep quality index after treatment
timeFrame: Baseline, 1 month and after the completion of treatment at 4 months
measure: Improve of scale of anxiety and depression after treatment
timeFrame: Baseline, 1 month and after the completion of treatment at 4 months
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Son Llatzer University Hospital
state: Balear Islands
Study officials:
affiliation: Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain
name: Javier Mata, MD
role: PRINCIPAL_INVESTIGATOR
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