Neck PainNCT03844802
Effectiveness of Dry Needling in Chronic Neck Pain.
A study testing Local Dry needling and exercise, Distal Dry needling and exercise and Exercise in people with Neck Pain, run by University of Seville at 1 site in Spain.
Trial summary
Objectives: To investigate the effect of combining real or placebo dry needling with therapeutic exercise in self-reported pain, pressure pain sensitivity, neck disability, global rating of change (GROC) scale, muscle viscoelastic properties (muscle tone and stiffness) and left/right discrimination ability in adults… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Local Dry needling and exercise, Distal Dry needling and exercise and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2019to 30 Jul 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of non-specific mechanical neck pain.
- Pain lasting for more than 3 months of duration.
- Self-reported pain higher than 3 in the Numeric Pain Rating Scale.
- Self-reported neck disability higher than 5 in the Neck Disability Index.
Who cannot join
- Absence of pain during passive neck rotation.
- Higher pain intensity in neutral position than during passive neck rotation.
- Absence of ipsilateral pain during passive neck rotation.
- Previous history of surgery of the cervical spine or upper extremity.
- Previous history of whiplash, diagnosis of fibromyalgia, or any neurological, inflammatory or rheumatological disease.
- Presence of two or more positive signs indicative of neural compression (sensitivity disorders, myotomic weakness in the upper extremities, or alteration in deep tendon reflexes).
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- Radiological signs of root compression or spinal stenosis.
- Having received physical therapy treatment in the month prior to the start of the study.
- Analgesic and / or anti-inflammatory treatment in the last 72 h.
- Diagnosis of psychiatric disorders with ongoing medical treatment.
- Pregnancy or breastfeeding.
- Pending litigation in progress.
- Any contraindication to the use of dry needling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Real or Placebo Dry Needling Combined With Therapeutic Exercise in Adults With Chronic Neck Pain
Objectives: To investigate the effect of combining real or placebo dry needling with therapeutic exercise in self-reported pain, pressure pain sensitivity, neck disability, global rating of change (GROC) scale, muscle viscoelastic properties (muscle tone and stiffness) and left/right discrimination ability in adults with chronic non-specific neck pain.
Design: Quantitative, experimental, longitudinal, prospective, and single blinded study.
Read more
Subjects: Participants aged between 18 and 60 years, and with non specific neck pain of at least 3 months of evolution.
Methods: Participants will be randomly allocated in four groups: a) isolated use of a home based therapeutic exercise (TE) program (TE Group); b) combination of the exercise program and the use of deep dry needling (DN) in neck shoulder muscles with active or latent myofascial trigger points (MTrPs) in order to elicit local twitch responses (LTR) (TE + local DN Group); c) therapeutic exercise combined with DN applied distally from the muscle areas with MTrPs and, therefore, without, eliciting LTRs (TE + distal DN Group); and d) therapeutic exercise program combined with placebo DN (TE + placebo DN Group).
Read the detailed description
All groups will be instructed by a physiotherapist in the performance of protocol of neck-shoulder exercises. This program will be carried out at home for at least three days a week during three months. The exercise protocol includes active mobilization, stretching and strengthening (concentric/eccentric, isotonic, and isometric) exercises. All participants will be given a booklet with a detailed description of every single exercise.
Those participants included in any of the DN groups will undergo 3 sessions of treatment (1 session per week during 3 consecutive weeks). In each session, the physiotherapist in charge of the intervention will assess the presence of active or latent MTrPs in severa neck shoulder muscles. The selected muscles have been previously described as having a higher prevalence of MTrPs in adults with chronic neck pain: a) scalene muscles; b) levator scapulae; c) splenius cervicis; d) cervical multifidus; and e) upper trapezius trapezius. The location of the trigger points will be carried out following the recommendations and guidelines described in the literature.
Those in the TE + local DN group will receive deep DN, using a fast-in fast-out technique, as described by Hong. The needle, once inserted in the muscle with a 10 to 20 mm depth, will be mobilized in a quick ascending and descending motion, in order to evoke the so-called LTRs. A minimum of 3 to 6 LTRs will be elicited in each muscle.
For patients in the TE + distal DN group, the deep DN intervention will be carried out in those muscles with MTrPs, but at a remote location from the MTrP area. The same evaluation and intervention protocol previously described for the TE + local DN group will be carried out. The main difference is that, in this group, DN will not elicit LTRs. Instead, DN will be applied at a minimum distance of 1-1.5 cm from the MTrP locus.
Finally, in the TE + placebo DN group, the therapeutic exercise program will be combined with DN using using a Dong Bang placebo needle, similar to the Streitberger placebo needle. These needles are designed with a retractable system. Therefore, these placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.
- Conditions
- Neck Pain
- Being tested
- Local Dry needling and exercise, Distal Dry needling and exercise, Sham dry needling and exercise, Exercise
- Keywords
- neck pain, randomized control trial, trigger points, dry needling, physical therapy, placebo, therapeutic exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Dry needling and exerciseOther
Deep dry needling will be applied bilaterally in the locus of active or latent myofascial trigger points of several neck shoulder muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius). The presence of active or latent myofascial trigger points will be assessed according to the diagnostic procedures described by Travell and Simons. The dry needling intervention technique will be the fast in-fast out Hong technique, with a minimum of 3 to 6 local twitch responses to be elicited.
Patients will perform a home based therapeutic neck exercises program.
Distal Dry needling and exerciseOther
Patients in this group will undergo deep dry needling at a remote spot from the locus of the myofascial trigger point. As a result no local twitch response should be elicited. As in the previous group, dry needling will be carried out in the same assessed muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for these participants will be to insert the needle in a location in the same muscle, but far away (at least 1 to 1.5 cm) from the location of the myofascial trigger point. Likewise, the needle will be inserted without the intention to evoke local twitch responses. Therefore, the entry and exit of the needle will be performed in a slower fashion.
Patients will perform a home based therapeutic neck exercises program.
Sham dry needling and exerciseOther
Patients in this group will undergo sham-placebo dry needling. For that purpose, placebo dry needling will be carried out in the same muscles previously described (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points. The intervention technique will be carried out in the locus of the trigger point but using placebo needles. For this placebo group, a simulation needle procedure using a Dong Bang placebo needle, similar to the Streitberger needle, will be used. The placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.
Patients will perform a home based therapeutic neck exercises program.
ExerciseOther
Patients will perform a home based therapeutic neck exercises program.
| Study group | Role | What they receive |
|---|---|---|
| Local dry needling and exercise | Experimental | The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 dry needling session a week during 3 consecutive weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months. Receives: Other: Local Dry needling and exercise |
| Distal dry needling and exercise | Active comparator | The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in distant area from the location of active or latent myofascial trigger points of different neck-shoulder muscles. Therefore, dry needling will be applied in the same muscle but at a remote site from the locus of the myofascial trigger point, and, therefore, without evoking local twitch responses. Patients will receive 1 dry needling session a week during 3 weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months. Receives: Other: Distal Dry needling and exercise |
| Sham/placebo dry needling and exercise | Active comparator | The intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 "placebo dry needling" session a week during 3 weeks (3 sessions in total). Therefore, participants in this group will receive simulated dry needling (with sham placebo needles, that will not actually penetrate the skin) in those neck muscles with active or latent myofascial trigger points. As formerly stated, the placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.They will also undergo the neck exercise program at home during these three weeks, and for the next three months. Receives: Other: Sham dry needling and exercise |
| Neck Exercise | Active comparator | The intervention protocol will consist only a home-based neck and shoulder exercise program. Participants in this group will be also assessed for the presence of active or latent myofascial trigger points in the neck-shoulder muscles. As in the other groups, they will be advised to carry out the exercise protocol for three weeks and the following three months. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Self-reported neck pain intensity in neutral head position at 6 months.
Current pain intensity in neutral head position, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Measured: From Baseline to after treatment,with a 3-month and a 6- month follow up
Change from baseline self-reported neck pain intensity associated to the most painful cervical rotation at 6 months
Current pain intensity during the most painful passive cervical rotation, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Change from baseline mean self-reported neck pain intensity during the last week at 6 months.
The subject is asked about the mean pain intensity during the previous week, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Measured: From Baseline to after treatment,with a 3-month and a 6- month follow up.
Change from baseline worst self-reported neck pain intensity in the last 24 hours at 6 months.
The subject is asked about the highest neck pain intensity in the last 24 hours, as assessed with a numeric pain rating scale (NPRS).The subject is asked about theThe Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Secondary outcomes (5)
Change from baseline self-reported neck related disability at 6 months.
This will be assessed with the Neck disability index (NDI). The neck disability index is a condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means no disability and 5 means the worst imaginable disability. The final score can range from 0 to 50 points (raw score) or from 0% to 100%, with 0 points or 0% denoting no activity limitations, and 50 points or 100% denoting complete activity limitation.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Change from baseline pressure pain sensitivity in neck shoulder muscles and brachial plexus nerve trunks at 6 months
Pressure pain thresholds, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer (model FPX 25, Wagner Instruments, Greenwich, CT, USA), with a 1-cm2 contact rubber probe. This outcome will be assessed over the upper trapezius, levator scapulae, anterior scalene and splenius cervicis muscles. The tibialis anterior muscle will be used as a remote location. Likewise, the pressure pain sensitivity will be evaluated over the median and cubital nerves.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Global Rating of Change.
A 15-point numeral global rating of change scale will be used. This scale ranges from -7 (very much worse), through 0 (unchanged) to +7 (completely recovered). This is a patient self-reported scale that assesses whether the patient condition has gotten worse, better, or stayed the same. Participants are asked to quantify the magnitude of that change, whether positive or not.
Measured: After treatment, with a 3-month and a 6- month follow up.
Change from baseline muscle viscoelastic properties (muscle tone and stiffness) at 6 months
The mechanical firmness of skeletal muscle in the absence of active contraction is related to the viscoelastic properties of the muscle tissue itself at rest, which can be quantified using myotonometry. The muscle tone and stiffness will be assessed over the upper trapezius, levator scapulae, anterior scalene, splenius cervicis and the tibialis anterior as a remote location. For this purpose, we will use a Myoton PRO (Myoton SA, Tallinn, Estonia) device. The MyotonPro is a low cost hand-held tool that uses multiple short impulses through a testing probe to measure several muscle properties, e.g., tone, stiffness, elasticity, and creep. The reliability and validity of the MyotonPro is well supported in healthy individuals, and in different musculoskeletal conditions.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Change from baseline left-Right discrimination ability at 6 months.
The neck related left-right discrimination ability will be collected through the use of the Recognise app (2016 Noigroup, Adelaide, Australia, http://www.noigroup.com). We will use the app specific for the Neck version, using a Huawei P10 (5.15 "mobile phone, Huawei Technologies Co., Shenzhen, Guangdong.) Left / right discrimination can be defined as the process of identifying one side of the body as distinct from the other or identifying whether a part of the body is rotated to the left or right. We will assess both the accuracy and speed of discrimination.
Measured: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start25 Mar 2019
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia
- Responsible party
- Principal investigator, Fernando Piña Pozo, University of Seville
- Investigators
- Alberto M Heredia-Rizo, PhD, Study director, Physiotherapy Department, University of Sevilla, SpainFernando Piña-pozo, PT, Principal investigator, Physiotherapy Department, University of Sevilla, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844802
- Sponsor's protocol ID
- Dry Needling
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Real or Placebo Dry Needling Combined With Therapeutic Exercise in Adults With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03844802
- Acronym / sponsor ID
- Dry Needling
- Conditions
- Neck Pain
- Keywords
- neck pain, randomized control trial, trigger points, dry needling, physical therapy, placebo, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Junta de Andalucia
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 18 Feb 2019 (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.
Objectives: To investigate the effect of combining real or placebo dry needling with therapeutic exercise in self-reported pain, pressure pain sensitivity, neck disability, global rating of change (GROC) scale, muscle viscoelastic properties (muscle tone and stiffness) and left/right discrimination ability in adults with chronic non-specific neck pain.
Design: Quantitative, experimental, longitudinal, prospective, and single blinded study.
Subjects: Participants aged between 18 and 60 years, and with non specific neck pain of at least 3 months of evolution.
Methods: Participants will be randomly allocated in four groups: a) isolated use of a home based therapeutic exercise (TE) program (TE Group); b) combination of the exercise program and the use of deep dry needling (DN) in neck shoulder muscles with active or latent myofascial trigger points (MTrPs) in order to elicit local twitch responses (LTR) (TE + local DN Group); c) therapeutic exercise combined with DN applied distally from the muscle areas with MTrPs and, therefore, without, eliciting LTRs (TE + distal DN Group); and d) therapeutic exercise program combined with placebo DN (TE + placebo DN Group).
Detailed description
All groups will be instructed by a physiotherapist in the performance of protocol of neck-shoulder exercises. This program will be carried out at home for at least three days a week during three months. The exercise protocol includes active mobilization, stretching and strengthening (concentric/eccentric, isotonic, and isometric) exercises. All participants will be given a booklet with a detailed description of every single exercise.
Those participants included in any of the DN groups will undergo 3 sessions of treatment (1 session per week during 3 consecutive weeks). In each session, the physiotherapist in charge of the intervention will assess the presence of active or latent MTrPs in severa neck shoulder muscles. The selected muscles have been previously described as having a higher prevalence of MTrPs in adults with chronic neck pain: a) scalene muscles; b) levator scapulae; c) splenius cervicis; d) cervical multifidus; and e) upper trapezius trapezius. The location of the trigger points will be carried out following the recommendations and guidelines described in the literature.
Those in the TE + local DN group will receive deep DN, using a fast-in fast-out technique, as described by Hong. The needle, once inserted in the muscle with a 10 to 20 mm depth, will be mobilized in a quick ascending and descending motion, in order to evoke the so-called LTRs. A minimum of 3 to 6 LTRs will be elicited in each muscle.
For patients in the TE + distal DN group, the deep DN intervention will be carried out in those muscles with MTrPs, but at a remote location from the MTrP area. The same evaluation and intervention protocol previously described for the TE + local DN group will be carried out. The main difference is that, in this group, DN will not elicit LTRs. Instead, DN will be applied at a minimum distance of 1-1.5 cm from the MTrP locus.
Finally, in the TE + placebo DN group, the therapeutic exercise program will be combined with DN using using a Dong Bang placebo needle, similar to the Streitberger placebo needle. These needles are designed with a retractable system. Therefore, these placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local dry needling and exercise | Experimental | Other: Local Dry needling and exerciseThe intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 dry needling session a week during 3 consecutive weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months. |
| Distal dry needling and exercise | Active comparator | Other: Distal Dry needling and exerciseThe intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in distant area from the location of active or latent myofascial trigger points of different neck-shoulder muscles. Therefore, dry needling will be applied in the same muscle but at a remote site from the locus of the myofascial trigger point, and, therefore, without evoking local twitch responses. Patients will receive 1 dry needling session a week during 3 weeks (3 sessions in total). They will also undergo the neck exercise program at home during these three weeks, and for the next three months. |
| Sham/placebo dry needling and exercise | Active comparator | Other: Sham dry needling and exerciseThe intervention protocol will combine a home-based neck and shoulder exercise program and the use of deep dry needling in the locus of active or latent myofascial trigger points of different neck-shoulder muscles. Patients will receive 1 "placebo dry needling" session a week during 3 weeks (3 sessions in total). Therefore, participants in this group will receive simulated dry needling (with sham placebo needles, that will not actually penetrate the skin) in those neck muscles with active or latent myofascial trigger points. As formerly stated, the placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle.They will also undergo the neck exercise program at home during these three weeks, and for the next three months. |
| Neck Exercise | Active comparator | Other: ExerciseThe intervention protocol will consist only a home-based neck and shoulder exercise program. Participants in this group will be also assessed for the presence of active or latent myofascial trigger points in the neck-shoulder muscles. As in the other groups, they will be advised to carry out the exercise protocol for three weeks and the following three months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of non-specific mechanical neck pain.
- Pain lasting for more than 3 months of duration.
- Self-reported pain higher than 3 in the Numeric Pain Rating Scale.
- Self-reported neck disability higher than 5 in the Neck Disability Index.
Key exclusion criteria (13 listed)
- Absence of pain during passive neck rotation.
- Higher pain intensity in neutral position than during passive neck rotation.
- Absence of ipsilateral pain during passive neck rotation.
- Previous history of surgery of the cervical spine or upper extremity.
- Previous history of whiplash, diagnosis of fibromyalgia, or any neurological, inflammatory or rheumatological disease.
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 |
|---|---|---|
| Local Dry needling and exerciseDeep dry needling will be applied bilaterally in the locus of active or latent myofascial trigger points of several neck shoulder muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius). The presence of active or latent myofascial trigger points will be assessed according to the diagnostic procedures described by Travell and Simons. The dry needling intervention technique will be the fast in-fast out Hong technique, with a minimum of 3 to 6 local twitch responses to be elicited. Patients will perform a home based therapeutic neck exercises program. | Other | Local dry needling and exercise |
| Distal Dry needling and exercisePatients in this group will undergo deep dry needling at a remote spot from the locus of the myofascial trigger point. As a result no local twitch response should be elicited. As in the previous group, dry needling will be carried out in the same assessed muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for these participants will be to insert the needle in a location in the same muscle, but far away (at least 1 to 1.5 cm) from the location of the myofascial trigger point. Likewise, the needle will be inserted without the intention to evoke local twitch responses. Therefore, the entry and exit of the needle will be performed in a slower fashion. Patients will perform a home based therapeutic neck exercises program. | Other | Distal dry needling and exercise |
| Sham dry needling and exercisePatients in this group will undergo sham-placebo dry needling. For that purpose, placebo dry needling will be carried out in the same muscles previously described (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points. The intervention technique will be carried out in the locus of the trigger point but using placebo needles. For this placebo group, a simulation needle procedure using a Dong Bang placebo needle, similar to the Streitberger needle, will be used. The placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a "real" needle. Patients will perform a home based therapeutic neck exercises program. | Other | Sham/placebo dry needling and exercise |
| ExercisePatients will perform a home based therapeutic neck exercises program. | Other | Neck Exercise |
Primary outcome
Change from baseline Self-reported neck pain intensity in neutral head position at 6 months.
Time frame: From Baseline to after treatment,with a 3-month and a 6- month follow up
Current pain intensity in neutral head position, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Change from baseline self-reported neck pain intensity associated to the most painful cervical rotation at 6 months
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Current pain intensity during the most painful passive cervical rotation, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Change from baseline mean self-reported neck pain intensity during the last week at 6 months.
Time frame: From Baseline to after treatment,with a 3-month and a 6- month follow up.
The subject is asked about the mean pain intensity during the previous week, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
Change from baseline worst self-reported neck pain intensity in the last 24 hours at 6 months.
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
The subject is asked about the highest neck pain intensity in the last 24 hours, as assessed with a numeric pain rating scale (NPRS).The subject is asked about theThe Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain.
5 secondary outcomes
Change from baseline self-reported neck related disability at 6 months.
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Change from baseline pressure pain sensitivity in neck shoulder muscles and brachial plexus nerve trunks at 6 months
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Global Rating of Change.
Time frame: After treatment, with a 3-month and a 6- month follow up.
Change from baseline muscle viscoelastic properties (muscle tone and stiffness) at 6 months
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
Change from baseline left-Right discrimination ability at 6 months.
Time frame: From Baseline to after treatment, with a 3-month and a 6- month follow up.
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 Jan 2024.
- 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.
Alberto M Heredia-Rizo, PhD study director
Physiotherapy Department, University of Sevilla, Spain
Fernando Piña-pozo, PT principal investigator
Physiotherapy Department, University of Sevilla, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Dry needling and exercise, Distal Dry needling and exercise and Exercise in people with Neck Pain, run by University of Seville at 1 site in Spain.
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 13 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 Jan 2024. 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 Spain. 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. 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 from baseline Self-reported neck pain intensity in neutral head position at 6 months. (time frame: From Baseline to after treatment,with a 3-month and a 6- month follow up). The study lists 4 primary outcomes in all. 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 18 Jan 2024.