Effectiveness of Acupuncture Clinical Pathway

Completed

• Conditions: Osteoarthritis, Knee; Shoulder Pain; Chronic Pain; Cervicalgia; Lumbar Back Pain; Headache; Musculoskeletal Pain
• Interventions: Procedure: Electroacupuncture

• Registration Number: NCT04490798
• Lead Sponsor: Hospital Son Llatzer

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.

Study Timeline

• Study Start: 2020-06-12
• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3245

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in pain intensity measured by VAS for pain at the completion of treatment	Baseline and after the completion of treatment at 4 months	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)

Secondary Outcome Measures

Name	Time	Method
Improve of quality of live scale after treatment	Baseline, 1 month and after the completion of treatment at 4 months	Patient-related quality of live by SF-12 measured. The Spanish version validated by Schmidt S et al is used
Number of responder patients to the acupuncture treatment.	Baseline, 1 month and after the completion of treatment at 4 months	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.
Reduction of pain medication intake after treatment	Baseline, 1 month and after the completion of treatment at 4 months	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.
Improve sleep quality index after treatment	Baseline, 1 month and after the completion of treatment at 4 months	Measured with the Pittsburgh Sleep Quality Index (PSQ). The Spanish version validated by Hita-Contreras F et al is used
Improve of scale of anxiety and depression after treatment	Baseline, 1 month and after the completion of treatment at 4 months	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.

Trial Locations

Locations (1)

Son Llatzer University Hospital; 🇪🇸 Palma, Balear Islands, Spain