The Effect of Dry Needling in Patients With Knee Osteoarthritis

January 18, 2021 updated by: Sophie Vervullens, Universiteit Antwerpen

The Effect of One Dry Needling Session on Pain and Central Pain Processing in Patients With Knee Osteoarthritis: a Randomized Controlled Trial

Research suggests that myofascial trigger points (MTrP) play an important role in explaining pain in patients with musculoskeletal knee disorders. Trigger points are usually defined as hypersensitive tender spots within taut bands of skeletal muscles that are painful on muscle stimulation and that usually elicit referred pain. Treatment of these trigger points could possibly alleviate symptoms in patients with knee pain. However, literature on the effect of trigger point therapy, dry needling in particular, in patients with musculoskeletal knee disorders is scarce. The purpose of this study is to examine the effect of trigger point therapy (dry needling (DN)) on pain, presence of altered central pain processing, muscle features and gait pattern in patients with knee osteoarthritis (KOA). 60 patients with symptomatic KOA will participate in this study. They will randomly be allocated in either an experimental group (EG) (dry needling technique) or a placebo group (PG) (sham needling technique). Pain (Visual analogue scale (VAS) & KOA outcome score (KOOS), muscle features during gait and gait pattern (3D gait analysis and surface electroMyoGraphy (EMG)) and presence of altered central pain processing (Central Sensitization Inventory (CSI), Quantitative Sensory testing (QST)) will be measured at baseline and 15 minutes after the intervention. Additionally, pain will be measured 3 days after the intervention. The investigators hypothesize that the effect on the outcome measures will be significantly larger in the EG compared to the PG.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A minimum age of fifty years old;

  • Diagnosed with KOA based on the American College of Rheumatology (ACR) clinical classification criteria(48), including:

    • A Kellgren-Lawrence grade of minimum two on radiography;
    • At least three months of chronical knee pain.

Exclusion Criteria:

  • Patients suffering from autoimmune and/or neurological disorders
  • Patients who had a major trauma/fracture of the lower limb in the past six months -
  • Patients who experienced other musculoskeletal problems than OA

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DN group
All identified MTrPs were inserted with a sterile filiform needle (0,30mm x 40mm or 0,30mm x 75mm, depending on the muscle) that moved up- and downwards until a local twitch response was elicited. When the repeated local twitch response fade away or the subject reported too much pain, the needle was removed. After the treatment, a 15 minutes break(51) was set up and the subjects were not permitted to use a hot pack or to stretch the muscle.
Other: Dry Needling
Sham Comparator: Sham needling (SN) group
The SN technique was similar to DN, except for penetrating the muscle. In this technique, the needle only penetrated the skin and was therefore impossible to provoke a local twitch response.
Other: Sham Needling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain sensation
Time Frame: Change from baseline pain sensation at 15minutes postintervention
Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
Change from baseline pain sensation at 15minutes postintervention
Pain sensation
Time Frame: Change from baseline pain sensation at 15minutes postintervention
Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
Change from baseline pain sensation at 15minutes postintervention
Pain sensation
Time Frame: Change from baseline pain sensation at 3days postintervention
Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
Change from baseline pain sensation at 3days postintervention
Pain sensation
Time Frame: Change from baseline pain sensation at 3days postintervention
Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
Change from baseline pain sensation at 3days postintervention
Pain sensation
Time Frame: Change from 15minutes postintervention pain sensation at 3days postintervention
Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
Change from 15minutes postintervention pain sensation at 3days postintervention
Pain sensation
Time Frame: Change from 15minutes postintervention pain sensation at 3days postintervention
Measured with the Knee Osteoarthritis Outcome Score- subscale pain, scored on a scale from 0 to 36, transferred from 0 to 100. Higher scores indicate a higher pain sensation.
Change from 15minutes postintervention pain sensation at 3days postintervention
Pain pressure thresholds
Time Frame: Change from baseline central pain processing at 15minutes postintervention
Measured with an digital algometer (kilogram force/ square cm)
Change from baseline central pain processing at 15minutes postintervention
Temporal summation
Time Frame: Change from baseline central pain processing at 15minutes postintervention
Measured with an digital algometer (kilogram force/ square cm)
Change from baseline central pain processing at 15minutes postintervention
Conditioned pain modulation
Time Frame: Change from baseline central pain processing at 15minutes postintervention
Measured with an digital algometer (test stimulus) and an inflatable cuff (conditioning stimulus). (kilogram force/ square cm)
Change from baseline central pain processing at 15minutes postintervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Muscle coactivation of musculus Vastus medialis and musculus Biceps femoris
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Muscle coactivation of musculus Vastus lateralis and musculus Biceps femoris
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius lateralis
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
Measured with wireless surface electromyography. Muscle activation patterns will be gathered through surface electrodes. Hereafter, the co-contraction index was calculated. Higher percentages indicate higher coactivation.
Change from baseline muscle coactivation at 15minutes postintervention
Stride time (seconds)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention
Stride length (meters)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention
Step time (meters/second)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention
Stance phase (%)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention
Step length (meters)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention
Step width (meters)
Time Frame: Change from baseline muscle coactivation at 15minutes postintervention
measured with force plates and markers to measure toe off and heel strike during a 3D motion analysis.
Change from baseline muscle coactivation at 15minutes postintervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sophie Vervullens, Universiteit Antwerpen

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3000201630444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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