The Effect of Dry Needling in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Dry Needling
* Other: Sham Needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: One group will receive dry needling session and one group will receive placebo treatment. A simple randomization on a website (www.randomizer.org) performed by a researcher (IB), independent from the executive researchers.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DN group<br>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<br> <br> |
| Sham Comparator: Sham needling (SN) group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation | 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 | 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 | 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 | 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 | 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 | 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 | Measured with an digital algometer (kilogram force/ square cm) | Change from baseline central pain processing at 15minutes postintervention | 
| Temporal summation | Measured with an digital algometer (kilogram force/ square cm) | Change from baseline central pain processing at 15minutes postintervention | 
| Conditioned pain modulation | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 (%) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry needling, central pain processing, pain, EMG measurements, muscle coactivation, gait pattern