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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04717167
Other study ID # B3000201630444
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date April 1, 2019

Study information

Verified date January 2021
Source Universiteit Antwerpen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dry Needling

Sham Needling


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universiteit Antwerpen

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Pain pressure thresholds Measured with an digital algometer (kilogram force/ square cm) Change from baseline central pain processing at 15minutes postintervention
Primary Temporal summation Measured with an digital algometer (kilogram force/ square cm) Change from baseline central pain processing at 15minutes postintervention
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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