Neck Pain, PosteriorNCT03241134
Changes in Surface EMG Activity After Dry Needling Compared to Sham Needling
A study testing Dry needling in people with Neck Pain, Posterior and Work-Related Condition, 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 surface EMG activity (signal amplitude and frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neck Pain, Posterior, Work-Related Condition
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2017to 9 May 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performing office work since at least one year
- Performing computer based tasks for at least 20 hours a week
- NRS > or equal to 3/10
- Clinical diagnosis of trapezius myalgia
- Trapezius myalgia is work-related and thus aggravates during working day/ week
- Presence of a trigger point in the upper trapezius muscle
Who cannot join
- Being in treatment during the study
- Traumatic injuries/surgery to neck and upper limb region
- Signs of cervical nerve root impingement
- Whiplash injury
- Cardiovascular, neurological, life threatening, systemic and metabolic diseases
- Diagnosis of fibromyalgia/chronic fatigue syndrome
Show all 9Show fewer
- Shoulder pathology
- Coagulation disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Surface Electromyographic Activity of the Upper Trapezius After Dry Needling, Compared to Sham Needling, in Office Workers With Work-related Trapezius Myalgia.
An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on surface EMG activity (signal amplitude and frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.
Read the detailed description
Neck-shoulder pain is a prevalent problem in office workers. These complaints are often related to myofascial dysfunctions of neck and shoulder muscles, in which the upper trapezius is a vulnerable victim due to prolonged static postures, repetitive upper limb movements and stress, often present during office and computer work. Myofascial dysfunction of the upper trapezius muscle is often referred to as "trapezius myalgia (TM)". Trapezius myalgia is clinically diagnosed with the presence of pain, palpable stiffness and tenderness of the upper part of the trapezius muscle. Several studies show that myofascial trigger points (MTrPs) play an important role in the development and maintenance of myofascial pain and trapezius myalgia. 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.
The pathophysiology of MTrPs is still unclear but several hypotheses exist. The most plausible explanation is that, due to sustained postures or repetitive low-level tasks, a sustained irritation of motor end plates with an excessive release of acetylcholine arises. This may lead to a persistent sarcomere contraction, leading to an impaired local blood circulation, a reduced tissue oxygenation and energy depletion, the sensitisation of nociceptors and thus the development of pain.
Dry needling (DN) is a myofascial treatment technique, which has been gaining interest in recent years. During dry needling, 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.
In this experimental study, 60 office workers with trapezius myalgia are recruited from several work places with predominantly computer based tasks. Participants are required to perform at least 20 hours of computer work a week, and this since at least one year. 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 the surface EMG activity (during rest ) and pain scores. Then, subjects will be required to perform a computer task during 20 minutes, surface EMG activity will be measured every 5 minutes. After this computer task, surface EMG activity (during rest ) and pain scores will be measured again. 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. After the treatment, surface EMG activity and pain scores will be measured again immediately after, 15 minutes and 30 minutes after completion of the intervention. Thereafter, pain scores will be asked daily, during 7 days after completion of the study.
- Conditions
- Neck Pain, Posterior, Work-Related Condition
- Being tested
- Dry needling, Sham needling
- Keywords
- Dry needling, Sham needling, Office workers, Myofascial pain, Surface electromyography
- Medical subject headings
- Neck Pain
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 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 skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down in multiple 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.
Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
Changes in resting EMG activity (amplitude, Root Mean Square) of the upper trapezius immediately after, 15 minutes and 30 minutes after dry needling, compared to EMG activity after a typing task, will be measured using surface electrodes placed bilaterally at the MTrP location of the upper trapezius. The change in resting surface EMG activity after dry needling will be compared with the change in surface EMG activity after sham needling.
Resting surface EMG activity will be expressed as a percentage of a submaximal reference contractions of the upper trapezius (% reference contractions)
Measured: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling
Secondary outcomes (3)
Changes in surface EMG activity (amplitude, Root Mean Square) of the upper trapezius during a fatiguing typing task of 20 minutes as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
Changes in EMG activity (amplitude, Root Mean Square) of the upper trapezius during a typing task of 20 minutes, will be measured by using surface electrodes placed bilaterally at the MTrP location of the upper trapezius.
EMG activity during this typing task will be expressed as a percentage of submaximal reference contractions of the upper trapezius (% reference contractions).
Measured: During the typing task, every five minutes EMG activity will be measured for 30 seconds
Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale
Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) after a typing task, immediately after dry or sham needling, 15 minutes after dry or sham needling and 30 minutes after dry or sham needling. In the 7 days following the treatment, pain scores will be asked daily to the participants.
Measured: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes after dry or sham needling, 30 minutes after dry or sham needling, daily during the seven days following the treatment
Changes in pain score after a typing task of 20 minutes as assessed by the numeric rating scale
Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) before and after a typing task of 20 minutes.
Measured: Immediately before and after a typing task of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start28 Aug 2017
- Primary completion9 May 2018
- Study completion9 May 2018
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 Neck Pain, PosteriorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241134
- Sponsor's protocol ID
- 01N04215
- Status last verified
- Dec 2023
- First submitted
- 2 Aug 2017
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Meulemeester K, Calders P, Cagnie B. Exploring the Underlying Mechanisms of Action of Dry Needling: What Is the Immediate Effect on Muscle Electrophysiology? An Experimental Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):18-25. doi: 10.1097/PHM.0000000000001732.
PubMed 34915542
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Surface Electromyographic Activity of the Upper Trapezius After Dry Needling, Compared to Sham Needling, in Office Workers With Work-related Trapezius Myalgia.
- ClinicalTrials.gov ID
- NCT03241134
- Acronym / sponsor ID
- 01N04215
- Conditions
- Neck Pain, Posterior, Work-Related Condition
- Keywords
- Dry needling, Sham needling, Office workers, Myofascial pain, Surface electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 7 Aug 2017 (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 surface EMG activity (signal amplitude and frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.
Detailed description
Neck-shoulder pain is a prevalent problem in office workers. These complaints are often related to myofascial dysfunctions of neck and shoulder muscles, in which the upper trapezius is a vulnerable victim due to prolonged static postures, repetitive upper limb movements and stress, often present during office and computer work. Myofascial dysfunction of the upper trapezius muscle is often referred to as "trapezius myalgia (TM)". Trapezius myalgia is clinically diagnosed with the presence of pain, palpable stiffness and tenderness of the upper part of the trapezius muscle. Several studies show that myofascial trigger points (MTrPs) play an important role in the development and maintenance of myofascial pain and trapezius myalgia. 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.
The pathophysiology of MTrPs is still unclear but several hypotheses exist. The most plausible explanation is that, due to sustained postures or repetitive low-level tasks, a sustained irritation of motor end plates with an excessive release of acetylcholine arises. This may lead to a persistent sarcomere contraction, leading to an impaired local blood circulation, a reduced tissue oxygenation and energy depletion, the sensitisation of nociceptors and thus the development of pain.
Dry needling (DN) is a myofascial treatment technique, which has been gaining interest in recent years. During dry needling, 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.
In this experimental study, 60 office workers with trapezius myalgia are recruited from several work places with predominantly computer based tasks. Participants are required to perform at least 20 hours of computer work a week, and this since at least one year. 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 the surface EMG activity (during rest ) and pain scores. Then, subjects will be required to perform a computer task during 20 minutes, surface EMG activity will be measured every 5 minutes. After this computer task, surface EMG activity (during rest ) and pain scores will be measured again. 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. After the treatment, surface EMG activity and pain scores will be measured again immediately after, 15 minutes and 30 minutes after completion of the intervention. Thereafter, pain scores will be asked daily, during 7 days after completion of the study.
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 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 skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down in multiple 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
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Performing office work since at least one year
- Performing computer based tasks for at least 20 hours a week
- NRS > or equal to 3/10
- Clinical diagnosis of trapezius myalgia
- Trapezius myalgia is work-related and thus aggravates during working day/ week
Key exclusion criteria (9 listed)
- Being in treatment during the study
- Traumatic injuries/surgery to neck and upper limb region
- Signs of cervical nerve root impingement
- Whiplash injury
- Cardiovascular, neurological, life threatening, systemic and metabolic diseases
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
Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
Time frame: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling
Changes in resting EMG activity (amplitude, Root Mean Square) of the upper trapezius immediately after, 15 minutes and 30 minutes after dry needling, compared to EMG activity after a typing task, will be measured using surface electrodes placed bilaterally at the MTrP location of the upper trapezius. The change in resting surface EMG activity after dry needling will be compared with the change in surface EMG activity after sham needling. Resting surface EMG activity will be expressed as a percentage of a submaximal reference contractions of the upper trapezius (% reference contractions)
3 secondary outcomes
Changes in surface EMG activity (amplitude, Root Mean Square) of the upper trapezius during a fatiguing typing task of 20 minutes as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
Time frame: During the typing task, every five minutes EMG activity will be measured for 30 seconds
Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale
Time frame: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes after dry or sham needling, 30 minutes after dry or sham needling, daily during the seven days following the treatment
Changes in pain score after a typing task of 20 minutes as assessed by the numeric rating scale
Time frame: Immediately before and after a typing task of 20 minutes
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 18 Dec 2023.
- Derived from this study: PubMed 34915542De Meulemeester K, Calders P, Cagnie B. Exploring the Underlying Mechanisms of Action of Dry Needling: What Is the Immediate Effect on Muscle Electrophysiology? An Experimental Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):18-25. doi: 10.1097/PHM.0000000000001732.
- 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.
Barbara Cagnie, PhD 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 Work-Related Condition, 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 6 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 18 Dec 2023. 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?
Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo (time frame: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling). 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 NCT03241134, 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 18 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.