Dry NeedlingNCT04695548
Physiotherapy in the Reduction of Post-needling Soreness
A study testing Concentric contraction exercise, Isometric contraction exercise and Eccentric contraction exercise in people with Dry Needling and Soreness, Muscle, run by University of Alcala at 1 site in Spain.
Trial summary
Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Needling, Soreness, Muscle, Trigger Point Pain, Myofascial
- What is being tested?
- Concentric contraction exercise, Isometric contraction exercise and Eccentric contraction exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2021to 30 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;
- Cervical pain.
- Presence of an active PGM in the upper trapezius muscle.
Who cannot join
- Traumatic history in the cervical region;
- Inability to understand or perform the required exercises;
- Pregnancy in the first trimester;
- Altered state of coagulation;
- Immunosuppression status;
- State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
- Unavoidable fear of needles;
- Lack of knowledge about the use of the WhatsApp or Telegram messaging platform
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical University Physiotherapy and pain
Alcalá de Henares, Madrid, 2805
About this study
Official title: Comparison of Isometric, Concentric, Eccentric Exercise and Passive Stretching in the Reduction of Post-needling Soreness in Patients With Cranial and/or Cervical Pain Related to Myofascial Pain
Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique.
So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.
Read the detailed description
Main objective. To figure out if one of the four techniques (isometric, concentric, eccentric contraction exercise and analytic passive stretching) is more effective for reducing post- needling soreness immediately, at 12, 24, 48 and 72 hours.
Objectives. To verify if there is a correlation between independent variables and post-needling soreness.
Study type. Non-blinded randomized clinical trial. Intervention. Dry needling on an active myofascial trigger point in superior trapezius, followed by one of the following treatments according to the specific group: 1) concentric contraction exercise, 2) isometric contraction exercise, 3) eccentric contraction exercise or 4) analytic passive stretching.
- Being tested
- Concentric contraction exercise, Isometric contraction exercise, Eccentric contraction exercise, Analytic passive stretching
- Medical subject headings
- Myalgia, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentric contraction exerciseOther
Also called Muscle concentric contraction
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
Isometric contraction exerciseOther
Also called Muscle isometric contraction
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds
Eccentric contraction exerciseOther
Also called Muscle eccentric contraction
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds.
Analytic passive stretchingOther
Also called Muscle passive stretching
The patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Concentric contraction exercise | Experimental | After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds Receives: Other: Concentric contraction exercise |
| Isometric contraction exercise | Experimental | After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds Receives: Other: Isometric contraction exercise |
| Eccentric contraction exercise | Experimental | After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds Receives: Other: Eccentric contraction exercise |
| Analytic passive stretching. | Experimental | After applying the dry needling technique to the upper trapezius muscle, the patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds. Receives: Other: Analytic passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-needling soreness intensity
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
Secondary outcomes (3)
Pain Catastrophizing
This scale is a Likert-type questionnaire with 5 levels (0-4) that includes 13 items that measure 3 dimensions of catastrophism: magnification, rumination and despair. The Spanish version of this scale has shown to have an appropriate internal consistency, test-retest reliability and sensitivity to changes.
Measured: Change from Baseline Pain Catastrophizing at 72 hours.
Fear of Pain.
Fear of Pain Questionnaire. This scale is a Likert-type questionnaire with 5 levels (1-5) with 3 lists of 10 sub-items that contemplate 3 different aspects of fear of pain: fear of mild pain, fear of severe pain, fear of pain related to the area doctor. The Spanish version of this scale has shown to have an acceptable validity and reliability.
Measured: Change from Baseline Fear of Pain at 72 hours.
Pain Anxiety Symptoms
The Pain Anxiety Symptoms Scale. This Likert-type questionnaire with 6 levels (0-5) includes 20 items that measure 4 dimensions of pain anxiety: cognitive anxiety, escape / avoidance, fear and physiological anxiety. The Spanish version of this scale has been shown to have appropriate validity and reliability
Measured: Change from Baseline Pain Anxiety at 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start23 Feb 2021
- Primary completion25 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry NeedlingStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695548
- Sponsor's protocol ID
- CEIM/HU/2020/43
- Status last verified
- Jul 2021
- First submitted
- 2 Jan 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Isometric, Concentric, Eccentric Exercise and Passive Stretching in the Reduction of Post-needling Soreness in Patients With Cranial and/or Cervical Pain Related to Myofascial Pain
- ClinicalTrials.gov ID
- NCT04695548
- Acronym / sponsor ID
- CEIM/HU/2020/43
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Jan 2021 (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.
Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique.
So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.
Detailed description
Main objective. To figure out if one of the four techniques (isometric, concentric, eccentric contraction exercise and analytic passive stretching) is more effective for reducing post- needling soreness immediately, at 12, 24, 48 and 72 hours.
Objectives. To verify if there is a correlation between independent variables and post-needling soreness.
Study type. Non-blinded randomized clinical trial. Intervention. Dry needling on an active myofascial trigger point in superior trapezius, followed by one of the following treatments according to the specific group: 1) concentric contraction exercise, 2) isometric contraction exercise, 3) eccentric contraction exercise or 4) analytic passive stretching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Concentric contraction exercise | Experimental | Other: Concentric contraction exerciseAfter applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds |
| Isometric contraction exercise | Experimental | Other: Isometric contraction exerciseAfter applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds |
| Eccentric contraction exercise | Experimental | Other: Eccentric contraction exerciseAfter applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds |
| Analytic passive stretching. | Experimental | Other: Analytic passive stretchingAfter applying the dry needling technique to the upper trapezius muscle, the patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years;
- Cervical pain.
- Presence of an active PGM in the upper trapezius muscle.
Key exclusion criteria (8 listed)
- Traumatic history in the cervical region;
- Inability to understand or perform the required exercises;
- Pregnancy in the first trimester;
- Altered state of coagulation;
- Immunosuppression status;
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 |
|---|---|---|
| Concentric contraction exerciseAlso: Muscle concentric contractionThe participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds | Other | Concentric contraction exercise |
| Isometric contraction exerciseAlso: Muscle isometric contractionThe participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds | Other | Isometric contraction exercise |
| Eccentric contraction exerciseAlso: Muscle eccentric contractionThe participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds. | Other | Eccentric contraction exercise |
| Analytic passive stretchingAlso: Muscle passive stretchingThe patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds. | Other | Analytic passive stretching. |
Primary outcome
Post-needling soreness intensity
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
3 secondary outcomes
Pain Catastrophizing
Time frame: Change from Baseline Pain Catastrophizing at 72 hours.
Fear of Pain.
Time frame: Change from Baseline Fear of Pain at 72 hours.
Pain Anxiety Symptoms
Time frame: Change from Baseline Pain Anxiety at 72 hours.
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 2021.
- 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.
Daniel Pecos-Martin, PhD principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentric contraction exercise, Isometric contraction exercise and Eccentric contraction exercise in people with Dry Needling and Soreness, Muscle, run by University of Alcala 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 3 inclusion and 8 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 2021. 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?
Post-needling soreness intensity (time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.). 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 2021.