Neck PainNCT04060004
The Effects of Dry Needling on the Superficial Neck Musculature
A study testing Dry needling and Electrotherapy + therapeutic exercise in people with Neck Pain, run by University of Valladolid at 1 site in Spain.
Trial summary
The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling and Electrotherapy + therapeutic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2019to 27 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with myofascial neck pain
- Presence of at least one active myofascial trigger point on the superficial neck musculature
- Neck pain of at least 3 months
- Age 18-70
- Pain intensity between 20 and 100 mm in the Analog Visual Scale
- Neck disability index (NDI) greater than or equal to 15 points
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- Spanish speakers
- Patients who do not present contraindications for the use of dry needling (anticoagulants, nickel allergy or belenophobia)
- Patients who have not received physiotherapy or pharmacological treatment for neck pain for the last three months
Who cannot join
- History of cervical trauma
- Cervical spine surgery
- Vertebral fracture
- Cervical pain associated with whiplash
- Red flags (tumor, metabolic disorders or rheumatoid arthritis)
- Inflammatory lesion in the neck region
Show all 11Show fewer
- Pregnancy
- Fibromyalgia diagnosis
- Neck pain associated with radiculopathy
- Patients pending legal litigation
- Psychiatric pathology diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dry Needling on the Superficial Neck Musculature in Patients With Chronic Myofascial Pain: A Randomized Controlled Trial
The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena.
To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points.
This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.
Read the detailed description
The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group.
In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups.
For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group.
The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Sham dry needling, Electrotherapy + therapeutic exercise
- Keywords
- physical therapy
- 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 is a technique used by physiotherapists.
Sham dry needlingOther
Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.
Electrotherapy + therapeutic exerciseOther
Standard care of neck pain.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Electrotherapy + therapeutic exercise Receives: Other: Electrotherapy + therapeutic exercise |
| Experimental group 1 | Experimental | Electrotherapy + therapeutic exercise + dry needling Receives: Other: Dry needling; Other: Electrotherapy + therapeutic exercise |
| Experimental group 2 | Placebo comparator | Electrotherapy + therapeutic exercise + sham dry needling Receives: Other: Sham dry needling; Other: Electrotherapy + therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.
Measured: Baseline.
Neck pain
The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average of 11 days.
Cervical disability
The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.
Measured: Baseline.
Cervical disability
The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Motor control
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.
Measured: Baseline.
Motor control
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Secondary outcomes (10)
Neck range of motion
The investigators measure the neck range of motion with an inclinometer at baseline.
Measured: Baseline.
Neck range of motion
The investigators measure the neck range of motion with an inclinometer at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Pressure pain threshold
The investigators measure the pressure pain threshold with a digital algometer at baseline.
Measured: Baseline.
Pressure pain threshold
The investigators measure the pressure pain threshold with a digital algometer at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Kinesiophobia
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline.
Measured: Baseline.
Kinesiophobia
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at the end of the intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Pain catastrophism
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline.
Measured: Baseline.
Pain catastrophism
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at the end of intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Anxiety and depression
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline.
Measured: Baseline.
Anxiety and depression
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at the end of intervention (through study completion, an average 11 days).
Measured: Through study completion, an average 11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start5 Sep 2019
- Primary completion20 Feb 2020
- Study completion27 May 2021
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Medrano de la Fuente, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060004
- Sponsor's protocol ID
- 1.0 14/12/2018
- Status last verified
- Jul 2023
- First submitted
- 15 Aug 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dry Needling on the Superficial Neck Musculature in Patients With Chronic Myofascial Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04060004
- Acronym / sponsor ID
- 1.0 14/12/2018
- Conditions
- Neck Pain
- Keywords
- physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 16 Aug 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.
The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena.
To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points.
This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.
Detailed description
The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group.
In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups.
For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group.
The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Electrotherapy + therapeutic exerciseElectrotherapy + therapeutic exercise |
| Experimental group 1 | Experimental | Other: Dry needling, Other: Electrotherapy + therapeutic exerciseElectrotherapy + therapeutic exercise + dry needling |
| Experimental group 2 | Placebo comparator | Other: Sham dry needling, Other: Electrotherapy + therapeutic exerciseElectrotherapy + therapeutic exercise + sham dry needling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with myofascial neck pain
- Presence of at least one active myofascial trigger point on the superficial neck musculature
- Neck pain of at least 3 months
- Age 18-70
- Pain intensity between 20 and 100 mm in the Analog Visual Scale
Key exclusion criteria (11 listed)
- History of cervical trauma
- Cervical spine surgery
- Vertebral fracture
- Cervical pain associated with whiplash
- Red flags (tumor, metabolic disorders or rheumatoid arthritis)
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 is a technique used by physiotherapists. | Other | Experimental group 1 |
| Sham dry needlingSham dry needling is a technique used by physiotherapists to compare the effects of dry needling. | Other | Experimental group 2 |
| Electrotherapy + therapeutic exerciseStandard care of neck pain. | Other | Control group, Experimental group 1, Experimental group 2 |
Primary outcome
Neck pain
Time frame: Baseline.
The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.
Neck pain
Time frame: Through study completion, an average of 11 days.
The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days).
Cervical disability
Time frame: Baseline.
The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.
Cervical disability
Time frame: Through study completion, an average 11 days.
The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days).
Motor control
Time frame: Baseline.
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.
Motor control
Time frame: Through study completion, an average 11 days.
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days).
10 secondary outcomes
Neck range of motion
Time frame: Baseline.
Neck range of motion
Time frame: Through study completion, an average 11 days.
Pressure pain threshold
Time frame: Baseline.
Pressure pain threshold
Time frame: Through study completion, an average 11 days.
Kinesiophobia
Time frame: Baseline.
Kinesiophobia
Time frame: Through study completion, an average 11 days.
Pain catastrophism
Time frame: Baseline.
Pain catastrophism
Time frame: Through study completion, an average 11 days.
Anxiety and depression
Time frame: Baseline.
Anxiety and depression
Time frame: Through study completion, an average 11 days.
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 19 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Electrotherapy + therapeutic exercise in people with Neck Pain, run by University of Valladolid 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 9 inclusion and 11 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 19 Jul 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 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. 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?
Neck pain (time frame: Baseline.). The study lists 6 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 19 Jul 2023.