Neck Pain, PosteriorNCT04725825
Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain
A study testing Dry needling in people with Neck Pain, Posterior and Trapezius Muscle Strain, run by University Ghent at 1 site in Belgium.
Trial summary
An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on pain intensity, local and peripheral hyperalgesia, and conditioned pain modulation in patients with chronic idiopathic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Posterior, Trapezius Muscle Strain
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 15 Jul 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain (symptom duration >3 months)
- Mean NRS score >3/10
- The presentation of a clinically relevant myofascial triggerpoint in the upper trapezius muscle.
Who cannot join
- Specific neck pain (eg.structural pathology like a cervical discus hernia, cervical nerve root compression, factures...)
- Major depression or psychiatric illness
- Cardiovascular, neurological, life threatening, systemic and metabolic diseases
- Other transferable diseases (HIV, hepatitis...)
- Coagulation disorders or use of coagulation medication
- Pregnancy or given birth the last year
Show all 9Show fewer
- Traumatic injuries/surgery to neck and upper limb region
- Diagnosis of fibromyalgia/chronic fatigue syndrome
- BMI > 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain: a Randomized Controlled Experimental Study
An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on pain intensity, local and peripheral hyperalgesia, and conditioned pain modulation in patients with chronic idiopathic neck pain.
Read the detailed description
Chronic idiopathic neck pain frequently has a myofascial origin. This cervical myofascial pain is caused by myofascial trigger points (MTrPs). Myofascial trigger points are defined as hyperirritable nodules in a contracture of skeletal muscle fibers, which can cause pain symptoms, motor symptoms as well as autonomic symptoms.
Many chronic pain populations (e.g. chronic whiplash associated disorders, fibromyalgia, chronic low back pain) show impaired pain processing and signs of central sensitisation. Central pain processing is defined as an increased responsivity of the nociceptive neurons in the central nerve system and is characterized by hyperalgesia (increased pain after a painful stimuli), allodynia (pain caused by a non-painful stimuli) and temporal summation (increased pain response after repeated stimuli with the same intensity). Hyperalgesia can be divided in local (increased sensitivity in the area of the complaints) and peripheral (increased sensitivity at remote area's). Furthermore, deficient inhibitory pain modulation can be present in this population. Conditioned pain modulation (CPM) can be measured by combining a painful conditioning stimuli (e.g. cold or heat) on a remote location, with a painful test stimuli.
Cervical myofascial pain is often treated by dry needling (DN). DN is a myofascial treatment technique, which has been gaining interest in recent years. During DN, a thin, solid filiform needle is inserted directly into the MTrP. During this treatment, local twitch responses can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increased local blood flow, recovery of the muscle metabolism and thus a reduction of pain and stiffness. By deactivation of the source of pain, chronification of the pain can be prevented.
Up to this moment, there are no studies that investigated the central effects of DN. The aim of this study is to compare the effects of DN with sham needling on pain intensity, local and peripheral hyperalgesia and CPM, in patients with chronic idiopathic neck pain. Therefore, 100 patients will be recruited. Participants are included based on online questionnaires, a clinical examination of neck and shoulder, and the identification of a MTrP in the upper trapezius muscle. All participants will receive information and have to sign an informed consent form. Participants will be subjected to baseline assessment, which involves measurements of pain scores, hyperalgesia (pressure pain thresholds (PPT) by algometry) and CPM (by combining immersion of the hand in hot water while repeating the PPT). Then, participants will be randomly allocated to either a dry needling group or a sham needling group. The dry needling group will receive a dry needling treatment at the identified trigger point location of the upper trapezius, whereas the sham needling group will receive an intervention in which the needle only penetrates the skin but not the fascia and muscle tissue. The one-time intervention of both groups will take approximately 15 minutes. After the treatment, the baseline measurements will be repeated.
- Conditions
- Neck Pain, Posterior, Trapezius Muscle Strain
- Being tested
- Dry needling, Sham needling
- Keywords
- Dry Needling, Sham Needling, Myofascial Pain Syndrome, Central Pain Modulatory Effects
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
Sham needlingOther
During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | A single dry needling session will be performed on the dominant painful trapezius muscle, with the patient lying in prone position. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down (fast-in, fast-out technique) in three different directions.
In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct. Receives: Other: Dry needling |
| Sham needling | Sham comparator | A single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated. Receives: Other: Sham needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distant Pressure Pain Threshold
A distant standardised PPT will be assessed using a digital handheld pressure algometer (FDX; Wagner Instruments) at the quadriceps muscle of the dominant painful side to measure distant hyperalgesia.
To measure the PPT, the researcher will apply the digital algometer to each of the indicated points with a round rubber end of 1 cm² and an increasing pressure of circa 1 N/s. As soon as the sensation of the subject shifts from a comfortable pressure to an altered, unpleasant feeling, the participant reports this and the test will be finished.
Each point will be measured twice with a 30-second interval in between and all measurements will be performed by one researcher in the same standardised position for each point and will be executed in a randomised order per patient.
Measured: Baseline and immediately after the intervention
Secondary outcomes (3)
Numeric Rating Scale (NRS)
The neck pain of the patients will be rated on an 11-point NRS at the beginning of the trial. After the hot water immersion (CPM; at baseline and post-intervention), patients will also be asked to score the pain caused by the hot water on a NRS. Minimum value is zero; a score of zero means no pain (= better outcome) and maximum score is 10, which indicates the worst pain possible (=worse outcome).
Measured: Baseline and immediately after the intervention
Change in Conditioned Pain Modulation
Participants will be asked to put their (non-dominant) hand (up to a marked line on the wrist) in a bath (VersaCool, Thermo Fisher Scientific, Waltham, Massachusetts) with demineralised circulating water maintained at 46,5°C for one minute. To maximise the CPM effect, the non-dominant hand will be used.
During this minute, participants will be encouraged to persevere after 30 and after 45 seconds by one of the investigators. The PPTs will be used as the test stimulus.These will be measured pre- and post immersion.The difference between the pre- and post immersion PPTs will be used to assess the effectiveness of the CPM.
Measured: baseline and immediately after the intervention
Change in local Pressure Pain Threshold
Two local standardised PPTs will be assessed using a digital handheld pressure algometer (FDX; Wagner Instruments) at the dominant painful and non-dominant painful upper trapezius muscle to measure local hyperalgesia.
To measure the PPT, the researcher will apply the digital algometer to each of the indicated points with a round rubber end of 1 cm² and an increasing pressure of circa 1 N/s. As soon as the sensation of the subject shifts from a comfortable pressure to an altered, unpleasant feeling, the participant reports this and the test will be finished.
Each point will be measured twice with a 30-second interval in between and all measurements will be performed by one researcher in the same standardised position for each point and will be executed in a randomised order per patient.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain, PosteriorStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VakgroepRevalidatiewetenschappen, University Ghent
- Investigators
- Mira Meeus, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725825
- Sponsor's protocol ID
- BC-05419
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain: a Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT04725825
- Acronym / sponsor ID
- BC-05419
- Conditions
- Neck Pain, Posterior, Trapezius Muscle Strain
- Keywords
- Dry Needling, Sham Needling, Myofascial Pain Syndrome, Central Pain Modulatory Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 27 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.
An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on pain intensity, local and peripheral hyperalgesia, and conditioned pain modulation in patients with chronic idiopathic neck pain.
Detailed description
Chronic idiopathic neck pain frequently has a myofascial origin. This cervical myofascial pain is caused by myofascial trigger points (MTrPs). Myofascial trigger points are defined as hyperirritable nodules in a contracture of skeletal muscle fibers, which can cause pain symptoms, motor symptoms as well as autonomic symptoms.
Many chronic pain populations (e.g. chronic whiplash associated disorders, fibromyalgia, chronic low back pain) show impaired pain processing and signs of central sensitisation. Central pain processing is defined as an increased responsivity of the nociceptive neurons in the central nerve system and is characterized by hyperalgesia (increased pain after a painful stimuli), allodynia (pain caused by a non-painful stimuli) and temporal summation (increased pain response after repeated stimuli with the same intensity). Hyperalgesia can be divided in local (increased sensitivity in the area of the complaints) and peripheral (increased sensitivity at remote area's). Furthermore, deficient inhibitory pain modulation can be present in this population. Conditioned pain modulation (CPM) can be measured by combining a painful conditioning stimuli (e.g. cold or heat) on a remote location, with a painful test stimuli.
Cervical myofascial pain is often treated by dry needling (DN). DN is a myofascial treatment technique, which has been gaining interest in recent years. During DN, a thin, solid filiform needle is inserted directly into the MTrP. During this treatment, local twitch responses can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increased local blood flow, recovery of the muscle metabolism and thus a reduction of pain and stiffness. By deactivation of the source of pain, chronification of the pain can be prevented.
Up to this moment, there are no studies that investigated the central effects of DN. The aim of this study is to compare the effects of DN with sham needling on pain intensity, local and peripheral hyperalgesia and CPM, in patients with chronic idiopathic neck pain. Therefore, 100 patients will be recruited. Participants are included based on online questionnaires, a clinical examination of neck and shoulder, and the identification of a MTrP in the upper trapezius muscle. All participants will receive information and have to sign an informed consent form. Participants will be subjected to baseline assessment, which involves measurements of pain scores, hyperalgesia (pressure pain thresholds (PPT) by algometry) and CPM (by combining immersion of the hand in hot water while repeating the PPT). Then, participants will be randomly allocated to either a dry needling group or a sham needling group. The dry needling group will receive a dry needling treatment at the identified trigger point location of the upper trapezius, whereas the sham needling group will receive an intervention in which the needle only penetrates the skin but not the fascia and muscle tissue. The one-time intervention of both groups will take approximately 15 minutes. After the treatment, the baseline measurements will be repeated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingA single dry needling session will be performed on the dominant painful trapezius muscle, with the patient lying in prone position. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down (fast-in, fast-out technique) in three different directions. In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct. |
| Sham needling | Sham comparator | Other: Sham needlingA single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic neck pain (symptom duration >3 months)
- Mean NRS score >3/10
- The presentation of a clinically relevant myofascial triggerpoint in the upper trapezius muscle.
Key exclusion criteria (9 listed)
- Specific neck pain (eg.structural pathology like a cervical discus hernia, cervical nerve root compression, factures...)
- Major depression or psychiatric illness
- Cardiovascular, neurological, life threatening, systemic and metabolic diseases
- Other transferable diseases (HIV, hepatitis...)
- Coagulation disorders or use of coagulation medication
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 needlingDry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness. | Other | Dry needling |
| Sham needlingDuring sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue. | Other | Sham needling |
Primary outcome
Change in distant Pressure Pain Threshold
Time frame: Baseline and immediately after the intervention
A distant standardised PPT will be assessed using a digital handheld pressure algometer (FDX; Wagner Instruments) at the quadriceps muscle of the dominant painful side to measure distant hyperalgesia. To measure the PPT, the researcher will apply the digital algometer to each of the indicated points with a round rubber end of 1 cm² and an increasing pressure of circa 1 N/s. As soon as the sensation of the subject shifts from a comfortable pressure to an altered, unpleasant feeling, the participant reports this and the test will be finished. Each point will be measured twice with a 30-second interval in between and all measurements will be performed by one researcher in the same standardised position for each point and will be executed in a randomised order per patient.
3 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: Baseline and immediately after the intervention
Change in Conditioned Pain Modulation
Time frame: baseline and immediately after the intervention
Change in local Pressure Pain Threshold
Time frame: Baseline and immediately after the intervention
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 9 Feb 2022.
- 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.
Mira Meeus principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Neck Pain, Posterior and Trapezius Muscle Strain, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 9 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in distant Pressure Pain Threshold (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.