Effectiveness of Acupuncture Clinical Pathway

NCT04490798 | Completed DMC

• 1 other identifier: ACUPATHWAY.R.1
• Study Type: observational
• Target: 3,245
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Lumbar Back Pain; Osteoarthritis, Knee; Headache; Shoulder Pain; Cervicalgia; Musculoskeletal Pain

Keywords

acupuncture treatment; clinical pathway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of responder patients to the acupuncture treatment.

  Baseline, 1 month and after the completion of treatment at 4 months

• Reduction of pain medication intake after treatment

  Baseline, 1 month and after the completion of treatment at 4 months

• Improve of quality of live scale after treatment

  Baseline, 1 month and after the completion of treatment at 4 months

• Improve sleep quality index after treatment

  Baseline, 1 month and after the completion of treatment at 4 months

• Improve of scale of anxiety and depression after treatment

  Baseline, 1 month and after the completion of treatment at 4 months

Study Arms (6)

Lumbar back pain

Patients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Musculoskeletal pain

Patients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Cervicalgia

Patients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Knee osteoarthritis

Patients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Headache

Patients with headache treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Shoulder pain

Patients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway.

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

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; Headache; Knee osteoarthritis; Lumbar back pain; Musculoskeletal pain; Shoulder pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (1)

Son Llatzer University Hospital

Palma, Balear Islands, 07198, Spain

Location

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Related Links

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MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Osteoarthritis, Knee; Headache; Shoulder Pain; Neck Pain; Musculoskeletal Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthralgia; Muscular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Javier Mata, MD

  Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: June 12, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 15, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)