Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

October 14, 2021 updated by: Tomás Tegiacchi, Universitat de Girona

Introduction:

Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results.

Objective:

Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis.

Methods:

A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Usual painful episode of 3 months or more
  • Morning stiffness of 15 minutes or more
  • Pain equal to or greater than 5 on the VAS
  • Grade 2 or greater on the Kellgren-Lawrence scale

Exclusion Criteria:

  • Corticosteroid infiltration in the 3 months prior to recruitment
  • Rehabilitation treatment one month prior to recruitment
  • With a knee prosthesis
  • Needle phobia
  • Pregnancy
  • With pacemakers
  • Cardiac arrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care plus TENS

Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care.

TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate.

Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions
Device: TENS
TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.
Other Names:
  • Transcutaneous electrical nerve stimulation
Experimental: Usual care plus Acupuncture

Participants in this group will receive acupuncture treatment and usual care.

Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm.

Usual care will be the same described in the Usual care plus TENS group
Other: Acupuncture
Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain at post intervention
Time Frame: At the end of the intervention, at the 4th week of the study
Pain will be assessed using the visual analogue scale (VAS)
At the end of the intervention, at the 4th week of the study
Change from Baseline Knee function at postintervention
Time Frame: At the end of the intervention, at the 4th week of the study
Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
At the end of the intervention, at the 4th week of the study
Change from Baseline Quality of life at postintervention
Time Frame: At the end of the intervention, at the 4th week of the study
Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
At the end of the intervention, at the 4th week of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain at 4 months
Time Frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Pain will be assessed using the visual analogue scale (VAS)
16 weeks afther the end of the intervention, at the 20th week of the study
Change from Baseline Knee function at 4 months
Time Frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
16 weeks afther the end of the intervention, at the 20th week of the study
Change from Baseline Quality of life at 4 months
Time Frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
16 weeks afther the end of the intervention, at the 20th week of the study
Drug intake postintervention
Time Frame: through study completion, an average of 1 year
Rescue drug intake will be collected in the data collection notebooks
through study completion, an average of 1 year
Adverse events postintervention
Time Frame: through study completion, an average of 1 year
Any adverse event related with the treatments will be will be noted in a collection sheet.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Girona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBRU0021-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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