Dry NeedlingNCT04968236
Dry Needling Versus Conservative Treatment in the Rectus Femoris Muscle Approach.
A study testing Deep Dry Needling, Superficial Dry Needling and passive stretching in people with Dry Needling and Stretch, run by University of Alcala at 2 sites in Spain.
Trial summary
In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Needling, Stretch, Rectus Femoris Muscle
- What is being tested?
- Deep Dry Needling, Superficial Dry Needling and passive stretching
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Aug 2021to 5 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years old.
- To have at least 70º of knee flexion.
- Be aware of and accept the study criteria (informed consent).
- Healthy subjects, without previous hip or knee pathology or involved musculature.
Who cannot join
- To have pain.
- Having pain in the quadriceps or hip at the time of the study.
- Currently following physiotherapy or analgesic treatment.
- Belenophobia (fear of needles).
- Recent surgery or trauma in the area.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Physiotherapy and Pain Institute
Alcalá de Henares, Madrid, 28805
About this study
Official title: Application of the Deep Versus Superficial Dry Needling and Stretching Technique in the Treatment of the Quadriceps Rectus Femoris Muscle.
In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques.
One of the objectives has been to improve the flexibility of those muscles that, due to the presence of myofascial trigger points, had a decrease in this parameter.
This study aims to determine whether the application of a dry needling technique is more effective than analytical stretching of the muscle.
Read the detailed description
Hypothesis of the study Deep dry needling of latent trigger points of the rectus femoris produces greater effects on flexibility, strength and pain than superficial dry needling or stretching.
- Overall objective: To compare the differences that occur in flexibility, strength and pain threshold to pressure after the application of deep dry needling, superficial dry needling and stretching on latent trigger points of the rectus femoris.
- Specific objectives To determine the changes produced by deep dry needling on flexibility, strength and pain threshold to pressure.
To determine the changes produced by superficial dry needling on flexibility, strength and pain threshold to pressure.
To determine the changes in flexibility, strength and pain threshold to pressure produced by conventional assisted stretching.
To check if the changes remain after 7 days of the application of the techniques.
To assess the inter-rater reliability of the Goniometer APP in the study sample.
- Conditions
- Dry Needling, Stretch, Rectus Femoris Muscle
- Being tested
- Deep Dry Needling, Superficial Dry Needling, passive stretching
- Keywords
- Deep Dry needling, Superficial dry needling, muscle stretching, rectus femoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Dry NeedlingOther
In-and-out into different directions technique to encounter sensitive spots in an MTrP region.
Superficial Dry NeedlingOther
This technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ.
passive stretchingOther
Type of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion.
| Study group | Role | What they receive |
|---|---|---|
| Deep dry needling | Experimental | With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a deep dry needling technique to the latent trigger point and make 10-12 incisions. Receives: Other: Deep Dry Needling |
| Superficial dry needling | Experimental | With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a superficial dry needling technique to the latent trigger point. Once the needle is placed in the subcutaneous cellular tissue, we manipulate the needle by twisting it until an unpleasant response is provoked. We keep the needle for 5 minutes Receives: Other: Superficial Dry Needling |
| Passive muscle stretching | Experimental | With the patient positioned in the supine position, the pelvis stabilized with a strap and the lower extremity where we are going to apply the rectus femoris muscle stretch placed outside the table, we perform a passive stretching technique, increasing hip extension and knee flexion until the patient feels the tension. The position is held for 60 seconds. Receives: Other: passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint range
Knee flexion motion assessment by using the Goniometer APP, which is a digital goniometer that has proven its reliability and validity.The overall concordance coefficient has shown very good to excellent with active measurements (range, 0.60-0.97).
Measured: Change from baseline at 7 days
Muscle strength
Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of flexion of knee. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in flexion of the knee, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98).
Measured: Change from baseline at 7 days
Secondary outcomes (1)
Pressure Pain Threshold (PPT)
An algometer Wagner FPI 10-WA will be used to determine the PPT in rectus femoris trigger points
Measured: Change from baseline at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start30 Aug 2021
- Primary completion15 Dec 2023
- Study completion5 Feb 2024
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968236
- Sponsor's protocol ID
- 06/2014
- Status last verified
- Feb 2024
- First submitted
- 9 Jul 2021
- Last updated
- 6 Feb 2024
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Deep Versus Superficial Dry Needling and Stretching Technique in the Treatment of the Quadriceps Rectus Femoris Muscle.
- ClinicalTrials.gov ID
- NCT04968236
- Acronym / sponsor ID
- 06/2014
- Conditions
- Dry Needling, Stretch, Rectus Femoris Muscle
- Keywords
- Deep Dry needling, Superficial dry needling, muscle stretching, rectus femoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 20 Jul 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.
In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques.
One of the objectives has been to improve the flexibility of those muscles that, due to the presence of myofascial trigger points, had a decrease in this parameter.
This study aims to determine whether the application of a dry needling technique is more effective than analytical stretching of the muscle.
Detailed description
Hypothesis of the study Deep dry needling of latent trigger points of the rectus femoris produces greater effects on flexibility, strength and pain than superficial dry needling or stretching.
- Overall objective: To compare the differences that occur in flexibility, strength and pain threshold to pressure after the application of deep dry needling, superficial dry needling and stretching on latent trigger points of the rectus femoris.
- Specific objectives To determine the changes produced by deep dry needling on flexibility, strength and pain threshold to pressure.
To determine the changes produced by superficial dry needling on flexibility, strength and pain threshold to pressure.
To determine the changes in flexibility, strength and pain threshold to pressure produced by conventional assisted stretching.
To check if the changes remain after 7 days of the application of the techniques.
To assess the inter-rater reliability of the Goniometer APP in the study sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep dry needling | Experimental | Other: Deep Dry NeedlingWith the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a deep dry needling technique to the latent trigger point and make 10-12 incisions. |
| Superficial dry needling | Experimental | Other: Superficial Dry NeedlingWith the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a superficial dry needling technique to the latent trigger point. Once the needle is placed in the subcutaneous cellular tissue, we manipulate the needle by twisting it until an unpleasant response is provoked. We keep the needle for 5 minutes |
| Passive muscle stretching | Experimental | Other: passive stretchingWith the patient positioned in the supine position, the pelvis stabilized with a strap and the lower extremity where we are going to apply the rectus femoris muscle stretch placed outside the table, we perform a passive stretching technique, increasing hip extension and knee flexion until the patient feels the tension. The position is held for 60 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 65 years old.
- To have at least 70º of knee flexion.
- Be aware of and accept the study criteria (informed consent).
- Healthy subjects, without previous hip or knee pathology or involved musculature.
Key exclusion criteria (6 listed)
- To have pain.
- Having pain in the quadriceps or hip at the time of the study.
- Currently following physiotherapy or analgesic treatment.
- Belenophobia (fear of needles).
- Recent surgery or trauma in the area.
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 |
|---|---|---|
| Deep Dry NeedlingIn-and-out into different directions technique to encounter sensitive spots in an MTrP region. | Other | Deep dry needling |
| Superficial Dry NeedlingThis technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ. | Other | Superficial dry needling |
| passive stretchingType of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion. | Other | Passive muscle stretching |
Primary outcome
Knee joint range
Time frame: Change from baseline at 7 days
Knee flexion motion assessment by using the Goniometer APP, which is a digital goniometer that has proven its reliability and validity.The overall concordance coefficient has shown very good to excellent with active measurements (range, 0.60-0.97).
Muscle strength
Time frame: Change from baseline at 7 days
Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of flexion of knee. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in flexion of the knee, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98).
1 secondary outcome
Pressure Pain Threshold (PPT)
Time frame: Change from baseline at 7 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 6 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Dry Needling, Superficial Dry Needling and passive stretching in people with Dry Needling and Stretch, run by University of Alcala at 2 sites 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 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Knee joint range (time frame: Change from baseline at 7 days). The study lists 2 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 6 Feb 2024.