Cervical PainNCT05624515
Efficacy of Dry Needling in Cervical Pain
A study testing dry needling and Ischaemic compression in people with Cervical Pain, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
The presence of latent myofascial trigger points (MTrPs) in the angular muscle of the scapula is one of the possible causes of non-specific neck pain. Dry needling (DN) and ischaemic compression (IC) techniques may be useful for the treatment of these MTrPs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- dry needling and Ischaemic compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 15 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with neck pain
- Patients presenting with trigger point activation of the angularis scapulae muscle
Who cannot join
- Patients who have an absolute fear of needles (belonephobia).
- Patients presenting with cervical pain with radiculopathy or irradiation of pain to the upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dry Needling and Ischaemic Compression of the Scapula Angularis Muscle in Patients With Cervicalgia. Randomised Clinical Trial
The presence of latent myofascial trigger points (MTrPs) in the angular muscle of the scapula is one of the possible causes of non-specific neck pain. Dry needling (DN) and ischaemic compression (IC) techniques may be useful for the treatment of these MTrPs. Methods: 80 participants were divided into two groups: the dry needling group, which received a single session of DN on the angular muscle plus hyperalgesia (n=40), and the IC group, which received a single session of IC on the angular muscle plus hyperalgesia (n=40). Pain intensity, pain pressure threshold (PPT), range of motion (ROM) and quality of life were assessed at baseline, immediately after, 48 hours and one week after treatment.
- Conditions
- Cervical Pain
- Being tested
- dry needling, Ischaemic compression
- Keywords
- dry needling, physiotherapy techniques, cervical pain, pain
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingDevice
Active trigger point puncture of the angularis scapulae muscle
Ischaemic compressionOther
Ischaemic compression at the active trigger point of the angularis scapulae muscle
| Study group | Role | What they receive |
|---|---|---|
| dry needling group | Experimental | Subjects undergoing dry needling of the angularis scapulae muscle Receives: Device: dry needling |
| ischaemic compression group | Experimental | Subjects undergoing ischaemic compression of the angularis scapulae muscle Receives: Other: Ischaemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity measured on the VAS scale with a minimum score of 0 (no pain) and a maximum score of 10 (highest possible pain endured).
Measured: 3 months
Secondary outcomes (3)
pressure pain threshold
pressure on the sore spot measured by algometer and the unit is Newtons.
Measured: 3 months
range of motion
Joint movement in the cervical spine measured in degrees using a goniometer
Measured: 3 months
quality life
Measured by physical activity questionnaire. Scoring is based on patients' responses. Minimum of 0, maximum of 100 points.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624515
- Sponsor's protocol ID
- 14/11/2022
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Navarro-Santana MJ, Sanchez-Infante J, Fernandez-de-Las-Penas C, Cleland JA, Martin-Casas P, Plaza-Manzano G. Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2020 Oct 14;9(10):3300. doi: 10.3390/jcm9103300.
PubMed 33066556Ballyns JJ, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Objective sonographic measures for characterizing myofascial trigger points associated with cervical pain. J Ultrasound Med. 2011 Oct;30(10):1331-40. doi: 10.7863/jum.2011.30.10.1331.
PubMed 21968483Lluch E, Arguisuelas MD, Coloma PS, Palma F, Rey A, Falla D. Effects of deep cervical flexor training on pressure pain thresholds over myofascial trigger points in patients with chronic neck pain. J Manipulative Physiol Ther. 2013 Nov-Dec;36(9):604-11. doi: 10.1016/j.jmpt.2013.08.004. Epub 2013 Oct 21.
PubMed 24152997Lew J, Kim J, Nair P. Comparison of dry needling and trigger point manual therapy in patients with neck and upper back myofascial pain syndrome: a systematic review and meta-analysis. J Man Manip Ther. 2021 Jun;29(3):136-146. doi: 10.1080/10669817.2020.1822618. Epub 2020 Sep 22.
PubMed 32962567Kietrys DM, Palombaro KM, Azzaretto E, Hubler R, Schaller B, Schlussel JM, Tucker M. Effectiveness of dry needling for upper-quarter myofascial pain: a systematic review and meta-analysis. J Orthop Sports Phys Ther. 2013 Sep;43(9):620-34. doi: 10.2519/jospt.2013.4668.
PubMed 23756457Stieven FF, Ferreira GE, de Araujo FX, Angellos RF, Silva MF, da Rosa LHT. Immediate Effects of Dry Needling and Myofascial Release on Local and Widespread Pressure Pain Threshold in Individuals With Active Upper Trapezius Trigger Points: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2021 Feb;44(2):95-102. doi: 10.1016/j.jmpt.2020.07.003. Epub 2021 Jan 9.
PubMed 33431282
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling and Ischaemic Compression of the Scapula Angularis Muscle in Patients With Cervicalgia. Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05624515
- Acronym / sponsor ID
- 14/11/2022
- Conditions
- Cervical Pain
- Keywords
- dry needling, physiotherapy techniques, cervical pain, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 22 Nov 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.
The presence of latent myofascial trigger points (MTrPs) in the angular muscle of the scapula is one of the possible causes of non-specific neck pain. Dry needling (DN) and ischaemic compression (IC) techniques may be useful for the treatment of these MTrPs. Methods: 80 participants were divided into two groups: the dry needling group, which received a single session of DN on the angular muscle plus hyperalgesia (n=40), and the IC group, which received a single session of IC on the angular muscle plus hyperalgesia (n=40). Pain intensity, pain pressure threshold (PPT), range of motion (ROM) and quality of life were assessed at baseline, immediately after, 48 hours and one week after treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling group | Experimental | Device: dry needlingSubjects undergoing dry needling of the angularis scapulae muscle |
| ischaemic compression group | Experimental | Other: Ischaemic compressionSubjects undergoing ischaemic compression of the angularis scapulae muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with neck pain
- Patients presenting with trigger point activation of the angularis scapulae muscle
Key exclusion criteria (2 listed)
- Patients who have an absolute fear of needles (belonephobia).
- Patients presenting with cervical pain with radiculopathy or irradiation of pain to the upper limb.
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 needlingActive trigger point puncture of the angularis scapulae muscle | Device | dry needling group |
| Ischaemic compressionIschaemic compression at the active trigger point of the angularis scapulae muscle | Other | ischaemic compression group |
Primary outcome
Pain intensity
Time frame: 3 months
Pain intensity measured on the VAS scale with a minimum score of 0 (no pain) and a maximum score of 10 (highest possible pain endured).
3 secondary outcomes
pressure pain threshold
Time frame: 3 months
range of motion
Time frame: 3 months
quality life
Time frame: 3 months
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 10 Mar 2023.
- Background: PubMed 33066556Navarro-Santana MJ, Sanchez-Infante J, Fernandez-de-Las-Penas C, Cleland JA, Martin-Casas P, Plaza-Manzano G. Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2020 Oct 14;9(10):3300. doi: 10.3390/jcm9103300.
- Results publication: PubMed 21968483Ballyns JJ, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Objective sonographic measures for characterizing myofascial trigger points associated with cervical pain. J Ultrasound Med. 2011 Oct;30(10):1331-40. doi: 10.7863/jum.2011.30.10.1331.
- Results publication: PubMed 24152997Lluch E, Arguisuelas MD, Coloma PS, Palma F, Rey A, Falla D. Effects of deep cervical flexor training on pressure pain thresholds over myofascial trigger points in patients with chronic neck pain. J Manipulative Physiol Ther. 2013 Nov-Dec;36(9):604-11. doi: 10.1016/j.jmpt.2013.08.004. Epub 2013 Oct 21.
- Results publication: PubMed 32962567Lew J, Kim J, Nair P. Comparison of dry needling and trigger point manual therapy in patients with neck and upper back myofascial pain syndrome: a systematic review and meta-analysis. J Man Manip Ther. 2021 Jun;29(3):136-146. doi: 10.1080/10669817.2020.1822618. Epub 2020 Sep 22.
- Results publication: PubMed 23756457Kietrys DM, Palombaro KM, Azzaretto E, Hubler R, Schaller B, Schlussel JM, Tucker M. Effectiveness of dry needling for upper-quarter myofascial pain: a systematic review and meta-analysis. J Orthop Sports Phys Ther. 2013 Sep;43(9):620-34. doi: 10.2519/jospt.2013.4668.
- Results publication: PubMed 33431282Stieven FF, Ferreira GE, de Araujo FX, Angellos RF, Silva MF, da Rosa LHT. Immediate Effects of Dry Needling and Myofascial Release on Local and Widespread Pressure Pain Threshold in Individuals With Active Upper Trapezius Trigger Points: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2021 Feb;44(2):95-102. doi: 10.1016/j.jmpt.2020.07.003. Epub 2021 Jan 9.
- Individual participant dataSharing planned: Undecided
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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 Ischaemic compression in people with Cervical Pain, run by Universidad Católica de Ávila 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 2 inclusion and 2 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 10 Mar 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. 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?
Pain intensity (time frame: 3 months). 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 NCT05624515, which also lists 6 linked publications.
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 10 Mar 2023.