Neck PainNCT05391568
Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain
A study testing Real Dry Needling in people with Neck Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Real Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2022to 20 Jun 2022
- 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
- Pain in the neck area, including the upper trapezius muscle;
- At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
- Ability to read and understand Spanish
- Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
- Ability to understand, write, and speak Spanish fluently
Who cannot join
- Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
- Cervical trauma
- Systemic diseases
- Pregnancy
- Psychiatric problems
- Fear of needles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.
Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain.
Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN
Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.
Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)
Aim #4: The secondary aim of the study is to correlate effects between clinical and other variables.
- Conditions
- Neck Pain
- Being tested
- Real Dry Needling, Sham Dry Needling
- Keywords
- Neck Ache, Cervicalgia, Cervicodynia, Neckache, Cervical Pain, Dry Needling
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Dry NeedlingOther
Needle will be placed at trapezius muscle. "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.
Sham Dry NeedlingOther
Sham needle will be placed at trapezius muscle. Simulated "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | One single session of DN Receives: Other: Real Dry Needling |
| Sham Dry Needling | Sham comparator | One single session of Sham DN Receives: Other: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Conductance
Measured in the hand of the needled upper trapezius. Measured in microsiemens.
Measured: Through study completion, an average of 20 minutes
Secondary outcomes (11)
Pressure Pain Sensitivity
Measurement of pressure pain threshold in C5-C6 zygapophyseal joints, dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of index finger and and the tibialis anterior muscle.
Measured: Baseline; Immediate (10 minutes after intervention)
Pressure Pain Stimuli for Temporal Summation
Measurement of pressure pain stimuli until reach a 6 points in the numeric pain rating scale in the interphalangeal joint of index finger.
Measured: Baseline; Immediate (10 minutes after intervention)
Temporal Summation
Pain response using a numeric pain rating scale will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger.
Measured: Baseline; Immediate (10 minutes after intervention)
Conditioned Pain Modulation (CPM)
CPM will be tested using the lower extremity submaximal effort tourniquet test. Pressure pain threshold (PPT) was assessed using algometry at the dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint at the index finger. After determining the pressure pain threshold (PPT) baseline, the conditioning stimulus was induced using a modified submaximal effort tourniquet procedure.Subjects verbally rated their leg pain until 6 was reached. Although the tourniquet remained inflated, PPT algometry assessment was performed in the same location as previously described (kg/cm2)
Measured: Baseline; Immediate (10 minutes after intervention)
Temporal Summation during conditioned stimuli.
Pain response using a numeric pain rating scale with a 10 scores (0-No pain - 10 The worst pain) will be assessed to pressure stimuli. Series of brief contacts (10 stimuli) of pressure pain threshold will be applied dorsal aspect of the midpoint between the base of the nail and the interphalangeal joint of the index finger using a lower extremity submaximal effort tourniquet test
Measured: Baseline; Immediate (10 minutes after intervention)
Pain Intensity (Numeric Pain Rating Scale)
Pain intensity measured with a 10 scores (0 - No pain - 10 The worst pain) numeric scale
Measured: Baseline; one week after intervention
Neck Pain-related Disability
The Northwick Park Neck Pain (NPQ) assess pain related disability by measuring pain and limitations in the daily activities
Measured: Baseline; one week after intervention
Global Rating of Change Scale (GRoC)
The patients answered about their perception of improvement during the treatment period on a scale ranging from -7 (a very great deal worse) to zero (about the same) to 7 (a very great deal better).
Measured: One week after intervention
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK-11) was used to evaluate fear of movement and avoidance. Range from 11 to 44 points.
Measured: Baseline; one week after intervention
Pain Catastrophizing
Pain catastrophizing scale (PCS) is a 12-item questionnaire with three components of catastrophizing: magnification, rumination, and helplessness (ranging from 0-52)
Measured: Baseline; one week after intervention
Pain Intensity during Intervention (Numeric Pain Rating Scale)
Pain intensity of the intervention was measured on a 10 points numeric pain rating scale (NPRS), 0 (no pain) to 10 (worst pain),
Measured: Baseline; immediate (ten minutes after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start31 May 2022
- Primary completion15 Jun 2022
- Study completion20 Jun 2022
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.
- More trials run by Universidad Complutense de MadridThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391568
- Sponsor's protocol ID
- 2015/18
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 22 Jun 2022
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05391568
- Acronym / sponsor ID
- 2015/18
- Conditions
- Neck Pain
- Keywords
- Neck Ache, Cervicalgia, Cervicodynia, Neckache, Cervical Pain, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 26 May 2022 (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.
Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain.
Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN
Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.
Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)
Aim #4: The secondary aim of the study is to correlate effects between clinical and other variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Other: Real Dry NeedlingOne single session of DN |
| Sham Dry Needling | Sham comparator | Other: Sham Dry NeedlingOne single session of Sham DN |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain in the neck area, including the upper trapezius muscle;
- At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
- Ability to read and understand Spanish
- Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
- Ability to understand, write, and speak Spanish fluently
Key exclusion criteria (6 listed)
- Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
- Cervical trauma
- Systemic diseases
- Pregnancy
- Psychiatric problems
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 |
|---|---|---|
| Real Dry NeedlingNeedle will be placed at trapezius muscle. "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle. | Other | Dry Needling |
| Sham Dry NeedlingSham needle will be placed at trapezius muscle. Simulated "Fast-in, Fast-out" technique will be used at the active trigger point of upper trapezius muscle. | Other | Sham Dry Needling |
Primary outcome
Skin Conductance
Time frame: Through study completion, an average of 20 minutes
Measured in the hand of the needled upper trapezius. Measured in microsiemens.
11 secondary outcomes
Pressure Pain Sensitivity
Time frame: Baseline; Immediate (10 minutes after intervention)
Pressure Pain Stimuli for Temporal Summation
Time frame: Baseline; Immediate (10 minutes after intervention)
Temporal Summation
Time frame: Baseline; Immediate (10 minutes after intervention)
Conditioned Pain Modulation (CPM)
Time frame: Baseline; Immediate (10 minutes after intervention)
Temporal Summation during conditioned stimuli.
Time frame: Baseline; Immediate (10 minutes after intervention)
Pain Intensity (Numeric Pain Rating Scale)
Time frame: Baseline; one week after intervention
Neck Pain-related Disability
Time frame: Baseline; one week after intervention
Global Rating of Change Scale (GRoC)
Time frame: One week after intervention
Kinesiophobia
Time frame: Baseline; one week after intervention
Pain Catastrophizing
Time frame: Baseline; one week after intervention
Pain Intensity during Intervention (Numeric Pain Rating Scale)
Time frame: Baseline; immediate (ten minutes after 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 22 Jun 2022.
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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 Real Dry Needling in people with Neck Pain, run by Universidad Complutense de Madrid 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 5 inclusion and 6 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 22 Jun 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 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?
Skin Conductance (time frame: Through study completion, an average of 20 minutes). 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 22 Jun 2022.