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

Completed

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • 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

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
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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.

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)

December 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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