- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04717167
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
Conditions
Intervention / Treatment
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.
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|
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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.
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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
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Pain pressure thresholds
Time Frame: Change from baseline central pain processing at 15minutes postintervention
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Measured with an digital algometer (kilogram force/ square cm)
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Change from baseline central pain processing at 15minutes postintervention
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Temporal summation
Time Frame: Change from baseline central pain processing at 15minutes postintervention
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Measured with an digital algometer (kilogram force/ square cm)
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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.
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Change from baseline muscle coactivation at 15minutes postintervention
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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.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3000201630444
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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