Placebo EffectNCT04571827
The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment
A study testing Dry Needling in people with Placebo Effect and Pain Intensity, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo Effect, Pain Intensity, Disability
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 2 Dec 2020
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and X years of age.
- Presence of at least one latent myofascial trigger point in the upper trapezius muscle.
- Patients who speak and understand Spanish correctly.
- Subjects without previous experience in dry puncture treatment.
Who cannot join
- If patients had neurological signs and symptoms.
- Subjects with a history of trauma, fracture or previous spinal surgery.
- Subjects with a history of musculoskeletal and/or rheumatological diseases.
- Unsurpassed fear of needles
- Coagulation disorders
- Infiltration of corticosteroids or local anesthetics for one year prior to the study.
- Taking analgesic or anti-inflammatory medication the week before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment: an Experimental Study
The general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle.
The specific objective of the study is to observe the interaction between patient expectations and hypoalgesic effects in patients who will receive the same technique but with different explanations about it before punction and which could influence on the modulation of post-punction pain.
Read the detailed description
Study design:
A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial was conducted, where both the study subject and the researcher performing the measurements do not know which treatment group they belong to.
Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were recruited personally for the study. All of them will have 15 incisions by dry needling in latent trigger point of the upper trapezium localized by palpation. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand. Patients were randomly assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups.
Each group will be given a different sentence: one group will be attempted to influence with positive expectation, another with neutral expectation, and yet another will be attempted to influence with negative expectation.
Measurement instruments
Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90º (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies.
Measurement of pain threshold to pressure
A digital algometer was used to measure mechanical hyperalgesia. The model used was the X® brand, consisting of a 1 cm2 cylindrical rubber attached to a pressure gauge. It is calibrated in kilograms (kg) and pounds. The scale expressed in kg/cm2 was used. All patients were familiarized with this test through a trial session. They were instructed to say STOP when the pressure sensation changed to painful. Three perpendicular measurements were made on an active or latent myofascial trigger point situated in upper trapezium muscle, the mean was calculated and the data were recorded for analysis. A rest period of 30 seconds was established between the measurements. A dermographic pencil was used to mark these points prior to measurement. The intra-assay reliability is high in the upper trapezius muscle (ICC = 0.94-0.97). The minimum detectable change (CMD) for considering the results as clinically relevant in the upper trapezius fibres has been shown to be between 0.45 kgf and 1.13 kgf.
Procedural protocol
Prior to the technique, the patient will be explained that the study seeks to observe if pain appears after the dry needling procedure. During the explanation, the desired expectation will be introduced:
- Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature"
- Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects"
- Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".
- Conditions
- Placebo Effect, Pain Intensity, Disability, Dry Needling
- Being tested
- Dry Needling
- Keywords
- placebo effect, Dry Needling, diffuse noxious inhibitory control, Myalgia
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Deep dry needling procedure
All subjects received a deep dry neddling technique on a latent myofascial trigger point of the upper trapezius muscle by isolating it by a pincer grasp with the thumb and index finger. This myofascial trigger point was previously found following the diagnostic criteria described by Travell \& Simons and Fernández-de-las-Peñas et al., and the deep dry needling intervention applied was based on the technique described by Hong.
The patients were placed in a prone position. Prior to the technique, the area was disinfected with an antiseptic solution. Fifteen incisions were made with a 0.26x40mm monofilament needle. The number of local twitch response made were noted. After removing the needle, at the end a soft compression was made with a cotton to reduce the possible appearance of bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Effect | Experimental | Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature"
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. Receives: Other: Dry Needling |
| Nocebo Effect | Experimental | Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. Receives: Other: Dry Needling |
| Neutral Effect | Experimental | Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects"
Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. Receives: Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Secondary outcomes (7)
Neck Disability Index
It will be used to measure the level of disability perceived by the patient as a result of their neck pain, after performing the technique and to check whether it appears during the control measurements. It is a questionnaire composed of 10 sections on different activities of daily living (ADLs); self-care, reading, lifting weights, driving, sleeping, recreational activities, work, concentration, pain intensity and headache. Each section scores from 0 to 5, with zero being no pain and five being the worst pain imaginable. (Maximum 50 points). Therefore, in order of appearance, of the 6 options, the first option of each item represents 0 and the last one 5. The higher the score obtained, the greater the patient's disability.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
STAI (State-Trait Anxiety)
Questionnaire composed of 20 items with 4 points each that evaluate "state anxiety" (transitory emotional condition influenced by environmental factors that decrease or increase anxiety) and another 20 that evaluate "trait anxiety" (personality factor that predisposes to suffer or not suffer anxiety). The 2-part score ranks patients at a percentile to the general population. The higher the score, the greater the anxiety. It is one of the most widely used tools in research to measure levels of general anxiety.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Beck II (Depression)
A 21-item scale used to assess the severity of depression. The patient has to select for each item the response alternative that best reflects his/her state during the last week. The total score is obtained by adding up the values of the selected items, which range from 0 to 3. The commonly accepted cut-off points for grading intensity/severity are as follows: 0 to 9, no depression; 10 to 18, mild depression; 19 to 29, moderate depression, and ≥ 30 points, severe depression.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
PCS (Pain Catastrophizing Scale)
It consists of 14 items valued on a 5-point scale. It evaluates the degree to which they have thoughts and feelings when they experience pain.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
TSK (Tampa Scale for Kinesiophobia)
17 items, 4 points each where higher scores indicate higher levels of fear of movement.
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
PASS-20 (Pain Anxiety Symptoms Scale)
It has four 5-item subscales that measure avoidance, fearful thoughts, cognitive and physiological anxiety, and pain responses. Participants rate each item on a 6-point scale ranging from never (0) to always (5).
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
FPQ-III (Fear of Pain Questionnaire)
It consists of 30 items, each with 5 points that measure fear over specific situations that normally produce pain
Measured: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion9 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placebo EffectStudies 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
- Model description
- Studio design: A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial will be carried out in which both the study subject and the researcher who made the measurements do not know which treatment group they belong to. Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were personally recruited for the study. All of them will have 15 incisions with dry needles in the latent trigger point of the upper trapezium. All patients will read the information sheet that explains what the study will consist of, as well as the informed consent form, which they will voluntarily sign before the intervention. Each group will be given a different sentence: one group will attempt to influence with a positive expectation, another with a neutral expectation, and yet another will attempt to influence with a negative expectation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleuterio Atanasio Sánchez Romero, Universidad Europea de Madrid
- Investigators
- Josué Fernández Carnero, PhD, Study director, Universidad Rey Juan CarlosEleuterio A Sánchez Romero, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571827
- Sponsor's protocol ID
- Expectative Influence
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez Romero EA, Lim T, Villafane JH, Boutin G, Riquelme Aguado V, Martin Pintado-Zugasti A, Alonso Perez JL, Fernandez Carnero J. The Influence of Verbal Suggestion on Post-Needling Soreness and Pain Processing after Dry Needling Treatment: An Experimental Study. Int J Environ Res Public Health. 2021 Apr 15;18(8):4206. doi: 10.3390/ijerph18084206.
PubMed 33921101
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment: an Experimental Study
- ClinicalTrials.gov ID
- NCT04571827
- Acronym / sponsor ID
- Expectative Influence
- Conditions
- Placebo Effect, Pain Intensity, Disability, Dry Needling
- Keywords
- placebo effect, Dry Needling, diffuse noxious inhibitory control, Myalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 1 Oct 2020 (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 general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle.
The specific objective of the study is to observe the interaction between patient expectations and hypoalgesic effects in patients who will receive the same technique but with different explanations about it before punction and which could influence on the modulation of post-punction pain.
Detailed description
Study design:
A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial was conducted, where both the study subject and the researcher performing the measurements do not know which treatment group they belong to.
Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were recruited personally for the study. All of them will have 15 incisions by dry needling in latent trigger point of the upper trapezium localized by palpation. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand. Patients were randomly assigned using GraphPad Software's QuickCals application (La Joya, CA, USA) to one of the 3 study groups.
Each group will be given a different sentence: one group will be attempted to influence with positive expectation, another with neutral expectation, and yet another will be attempted to influence with negative expectation.
Measurement instruments
Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90º (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies.
Measurement of pain threshold to pressure
A digital algometer was used to measure mechanical hyperalgesia. The model used was the X® brand, consisting of a 1 cm2 cylindrical rubber attached to a pressure gauge. It is calibrated in kilograms (kg) and pounds. The scale expressed in kg/cm2 was used. All patients were familiarized with this test through a trial session. They were instructed to say STOP when the pressure sensation changed to painful. Three perpendicular measurements were made on an active or latent myofascial trigger point situated in upper trapezium muscle, the mean was calculated and the data were recorded for analysis. A rest period of 30 seconds was established between the measurements. A dermographic pencil was used to mark these points prior to measurement. The intra-assay reliability is high in the upper trapezius muscle (ICC = 0.94-0.97). The minimum detectable change (CMD) for considering the results as clinically relevant in the upper trapezius fibres has been shown to be between 0.45 kgf and 1.13 kgf.
Procedural protocol
Prior to the technique, the patient will be explained that the study seeks to observe if pain appears after the dry needling procedure. During the explanation, the desired expectation will be introduced:
- Group with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature"
- Group with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects"
- Group with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Studio design: A randomized, longitudinal, experimental, prospective, parallel and double-blind clinical trial will be carried out in which both the study subject and the researcher who made the measurements do not know which treatment group they belong to. Participants The sample was composed of 42 healthy patients residing in the Community of Madrid, all of whom were personally recruited for the study. All of them will have 15 incisions with dry needles in the latent trigger point of the upper trapezium. All patients will read the information sheet that explains what the study will consist of, as well as the informed consent form, which they will voluntarily sign before the intervention. Each group will be given a different sentence: one group will attempt to influence with a positive expectation, another with a neutral expectation, and yet another will attempt to influence with a negative expectation.
| Arm | Type | Receives |
|---|---|---|
| Placebo Effect | Experimental | Other: Dry NeedlingGroup with positive expectation: "it is a very effective technique that achieves excellent results in the improvement of the cervical musculature" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. |
| Nocebo Effect | Experimental | Other: Dry NeedlingGroup with negative expectation: "this is a technique that will cause discomfort in the area of intervention of the cervical muscles after applying it ". Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. |
| Neutral Effect | Experimental | Other: Dry NeedlingGroup with neutral expectations: "It's a physical therapy technique used to treat neck pain and we're investigating its effects" Before the treatment, it will be explained to the patient that the study seeks to observe if pain appears after the dry needling. During the explanation, the desired expectation will be introduced. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between 18 and X years of age.
- Presence of at least one latent myofascial trigger point in the upper trapezius muscle.
- Patients who speak and understand Spanish correctly.
- Subjects without previous experience in dry puncture treatment.
Key exclusion criteria (7 listed)
- If patients had neurological signs and symptoms.
- Subjects with a history of trauma, fracture or previous spinal surgery.
- Subjects with a history of musculoskeletal and/or rheumatological diseases.
- Unsurpassed fear of needles
- Coagulation disorders
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 NeedlingDeep dry needling procedure All subjects received a deep dry neddling technique on a latent myofascial trigger point of the upper trapezius muscle by isolating it by a pincer grasp with the thumb and index finger. This myofascial trigger point was previously found following the diagnostic criteria described by Travell \& Simons and Fernández-de-las-Peñas et al., and the deep dry needling intervention applied was based on the technique described by Hong. The patients were placed in a prone position. Prior to the technique, the area was disinfected with an antiseptic solution. Fifteen incisions were made with a 0.26x40mm monofilament needle. The number of local twitch response made were noted. After removing the needle, at the end a soft compression was made with a cotton to reduce the possible appearance of bleeding. | Other | Neutral Effect, Nocebo Effect, Placebo Effect |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements.
7 secondary outcomes
Neck Disability Index
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
STAI (State-Trait Anxiety)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
Beck II (Depression)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
PCS (Pain Catastrophizing Scale)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
TSK (Tampa Scale for Kinesiophobia)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
PASS-20 (Pain Anxiety Symptoms Scale)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
FPQ-III (Fear of Pain Questionnaire)
Time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling
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 Apr 2022.
- Derived from this study: PubMed 33921101Sanchez Romero EA, Lim T, Villafane JH, Boutin G, Riquelme Aguado V, Martin Pintado-Zugasti A, Alonso Perez JL, Fernandez Carnero J. The Influence of Verbal Suggestion on Post-Needling Soreness and Pain Processing after Dry Needling Treatment: An Experimental Study. Int J Environ Res Public Health. 2021 Apr 15;18(8):4206. doi: 10.3390/ijerph18084206.
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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.
Josué Fernández Carnero, PhD study director
Universidad Rey Juan Carlos
Eleuterio A Sánchez Romero, PhD principal investigator
Universidad Europea de Madrid
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 in people with Placebo Effect and Pain Intensity, run by Universidad Europea 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 4 inclusion and 7 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 Apr 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. 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?
Visual Analog Scale (VAS) (time frame: Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling). 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 NCT04571827, which also lists 1 linked publication.
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 Apr 2022.