Osteoarthritis, KneeNCT04717167
The Effect of Dry Needling in Patients With Knee Osteoarthritis
A study testing Dry Needling in people with Osteoarthritis, Knee, run by Universiteit Antwerpen.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Dry Needling, Sham Needling
- Keywords
- dry needling, central pain processing, pain, EMG measurements, muscle coactivation, gait pattern
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Sham NeedlingOther
| Study group | Role | What they receive |
|---|---|---|
| DN group | Experimental | 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. Receives: Other: Dry Needling |
| Sham needling (SN) group | Sham comparator | 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. Receives: Other: Sham Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation
Measured with a Visual Analogue Scale, scored from 0 to 100, where higher scores indicate higher pain sensation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from 15minutes postintervention pain sensation at 3days postintervention
Pain pressure thresholds
Measured with an digital algometer (kilogram force/ square cm)
Measured: Change from baseline central pain processing at 15minutes postintervention
Temporal summation
Measured with an digital algometer (kilogram force/ square cm)
Measured: 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)
Measured: Change from baseline central pain processing at 15minutes postintervention
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline muscle coactivation at 15minutes postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Dec 2016
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Vervullens, Universiteit Antwerpen
- Investigators
- Sophie Vervullens, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717167
- Sponsor's protocol ID
- B3000201630444
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Vervullens S, Meert L, Baert I, Delrue N, Heusdens CHW, Hallemans A, Van Criekinge T, Smeets RJEM, De Meulemeester K. The effect of one dry needling session on pain, central pain processing, muscle co-contraction and gait characteristics in patients with knee osteoarthritis: a randomized controlled trial. Scand J Pain. 2021 Sep 30;22(2):396-409. doi: 10.1515/sjpain-2021-0091. Print 2022 Apr 26.
PubMed 34821140
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of One Dry Needling Session on Pain and Central Pain Processing in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04717167
- Acronym / sponsor ID
- B3000201630444
- Conditions
- Osteoarthritis, Knee
- Keywords
- dry needling, central pain processing, pain, EMG measurements, muscle coactivation, gait pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DN group | Experimental | Other: Dry NeedlingAll 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 needling (SN) group | Sham comparator | Other: Sham NeedlingThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A minimum age of fifty years old;
- Diagnosed with KOA based on the American College of Rheumatology (ACR) clinical classification criteria(48), including:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling | Other | DN group |
| Sham Needling | Other | Sham needling (SN) group |
Primary outcome
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.
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.
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.
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.
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.
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.
Pain pressure thresholds
Time frame: Change from baseline central pain processing at 15minutes postintervention
Measured with an digital algometer (kilogram force/ square cm)
Temporal summation
Time frame: Change from baseline central pain processing at 15minutes postintervention
Measured with an digital algometer (kilogram force/ square cm)
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)
12 secondary outcomes
Muscle coactivation of musculus Vastus medialis and musculus Semitendinosus
Time frame: 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
Muscle coactivation of musculus Vastus lateralis and musculus Semitendinosus
Time frame: 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
Muscle coactivation of musculus Tibialis anterior and musculus Gastrocnemius medialis
Time frame: 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
Stride time (seconds)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Stride length (meters)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Step time (meters/second)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Stance phase (%)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Step length (meters)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Step width (meters)
Time frame: Change from baseline muscle coactivation at 15minutes postintervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34821140Vervullens S, Meert L, Baert I, Delrue N, Heusdens CHW, Hallemans A, Van Criekinge T, Smeets RJEM, De Meulemeester K. The effect of one dry needling session on pain, central pain processing, muscle co-contraction and gait characteristics in patients with knee osteoarthritis: a randomized controlled trial. Scand J Pain. 2021 Sep 30;22(2):396-409. doi: 10.1515/sjpain-2021-0091. Print 2022 Apr 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Vervullens principal investigator
Universiteit Antwerpen
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Osteoarthritis, Knee, run by Universiteit Antwerpen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensation (time frame: Change from baseline pain sensation at 15minutes postintervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.