Anterior Cruciate Ligament ReconstructionACLNCT02699411
Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament.
A study testing Dry needling and Stability and propioception in people with Anterior Cruciate Ligament Reconstruction, run by European University Spain at 1 site in Spain.
Trial summary
We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Dry needling and Stability and propioception
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Sep 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- over eighteen and anatomically mature surgically break LCA and valued above using MRI and functional tests to confirm the rupture of the ligament.
Who cannot join
- Patients who did not reach 18 years of age and those over 55,
- postoperative complications
- cause myofascial or neuropathic pain in the lower limb, as lumba-sacral radiculopathy, neuropraxia, neurotmesis, axonotmesis or meralgia paresthetica;
- fibromyalgia.
- hypothyroidism
- iron deficiencies and patients who had a fear of needles (fear of needles).
- Lower limb differences.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jorge Velázquez Saornil
Madrid
Jorge Velázquez, Mr
Jorge Velázquez, jorgevelasa@yahoo.es
About this study
Official title: Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament. Single-Blind Randomized Clinical Trial.
We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty patients not be treated with dry needling after ACL surgery, using only proprioceptive exercises to the joint (group B).
Read the detailed description
It carries out a last fifteen days ECA surgical reconstruction of the anterior cruciate ligament. Twenty individuals in a group to be subjected to a technique of physiotherapy, dry needling were included. (Group A). Another group of twenty patients treated with conservative treatment performed a stability exercises and proprioception (Group B). Forty-six patients will be examined s. None had been previously operated by joint instability and all subjects were previously subjected to a diagnostic study by nuclear magnetic resonance before surgery and the diagnosis was confirmed by additional diagnostic testing. All patients will be evaluated by a physical therapist and Myofascial Trigger Point (PGM) of the vastus muscle will be evaluated.
patients using the following variables are evaluated:
- Pain: Visual Analog Scale (VAS) was used.
- Stiffness and physical function using the WOMAC scale (The Western Ontario and McMaster Universities Arthritis Index.).
- Range of motion of the knee joint: Scale ROM.
- Muscular strength, balance and propiocepción: Star Excursion by Balance Scale Test.
- Being tested
- Dry needling, Stability and propioception
- Keywords
- ligament anterior cruciate , dry needling, physioterapy, propioception, knee arthroplasty, vastus medialis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
dry needling Travell and Simons
Stability and propioceptionOther
Start excursion balance test, WOMAC; ROM, EVA.
| Study group | Role | What they receive |
|---|---|---|
| dry needling | Active comparator | Dry needling on the vastus is performed in patients undergoing ACL fortnight after the intervention and then evaluated. REL dry needling while supplies last twenty insertions before treatment, at midnight, a week and five weeks. Receives: Device: Dry needling |
| Stability and propioception | Active comparator | Proprioception and stability exercises in patients undergoing ACL fortnight after the intervention and then evaluates performed before treatment, at midnight, a week and five weeks. Receives: Other: Stability and propioception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree range of motion (ROM)
Measured: 24 hours
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 24 hours
Pain scores visual analog scale (EVA)
Measured: 24 hours
Scores of STAR BALANCE TEST
Measured: 24
Secondary outcomes (8)
Degree range of motion (ROM)
Measured: 1 week
Degree range of motion (ROM)
Measured: 5 weeks
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 1 week
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 5 weeks
Pain scores visual analog scale (EVA)
Measured: 1 week
Pain scores visual analog scale (EVA)
Measured: 5 weeks
Scores STAR BALANCE TEST
Measured: 1week
Scores STAR BALANCE TEST
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Velázquez Saornil, European University Spain
- Investigators
- Jorge Velázquez, Sr, Principal investigator, European University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699411
- Sponsor's protocol ID
- European University
- Acronym
- ACL
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Adachi N, Ochi M, Uchio Y, Iwasa J, Ryoke K, Kuriwaka M. Mechanoreceptors in the anterior cruciate ligament contribute to the joint position sense. Acta Orthop Scand. 2002 Jun;73(3):330-4. doi: 10.1080/000164702320155356.
PubMed 12143983Ahn JH, Chang MJ, Lee YS, Koh KH, Park YS, Eun SS. Non-operative treatment of ACL rupture with mild instability. Arch Orthop Trauma Surg. 2010 Aug;130(8):1001-6. doi: 10.1007/s00402-010-1077-4. Epub 2010 Mar 25.
PubMed 20336305Alentorn-Geli E, Myer GD, Silvers HJ, Samitier G, Romero D, Lazaro-Haro C, Cugat R. Prevention of non-contact anterior cruciate ligament injuries in soccer players. Part 1: Mechanisms of injury and underlying risk factors. Knee Surg Sports Traumatol Arthrosc. 2009 Jul;17(7):705-29. doi: 10.1007/s00167-009-0813-1. Epub 2009 May 19.
PubMed 19452139Domingo A, Mayoral O, Monterde S, Santafe MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9.
PubMed 23662122Baltaci G, Harput G, Haksever B, Ulusoy B, Ozer H. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 Apr;21(4):880-7. doi: 10.1007/s00167-012-2034-2. Epub 2012 Apr 29.
PubMed 22543515Sbihi A, Franceschi JP, Christel P, Colombet P, Djian P, Bellier G. [Anterior cruciate ligament reconstruction: biomechanical comparison on cadaver specimens using a single or double hamstring technique]. Rev Chir Orthop Reparatrice Appar Mot. 2004 Nov;90(7):643-50. doi: 10.1016/s0035-1040(04)70725-4. French.
PubMed 15625515Caraffa A, Cerulli G, Projetti M, Aisa G, Rizzo A. Prevention of anterior cruciate ligament injuries in soccer. A prospective controlled study of proprioceptive training. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):19-21. doi: 10.1007/BF01565992.
PubMed 8963746Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
PubMed 20949884Delince P, Ghafil D. Anterior cruciate ligament tears: conservative or surgical treatment? Knee Surg Sports Traumatol Arthrosc. 2013 Jul;21(7):1706-7. doi: 10.1007/s00167-012-2134-z. Epub 2012 Jul 13. No abstract available.
PubMed 22790441Diekstall P, Rauhut F. [Considerations for the indications for anterior cruciate ligament reconstruction. Results of conservative versus operative treatment]. Unfallchirurg. 1999 Mar;102(3):173-81. doi: 10.1007/s001130050390. German.
PubMed 10232033Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.
PubMed 23115475Fithian DC, Paxton EW, Stone ML, Luetzow WF, Csintalan RP, Phelan D, Daniel DM. Prospective trial of a treatment algorithm for the management of the anterior cruciate ligament-injured knee. Am J Sports Med. 2005 Mar;33(3):335-46. doi: 10.1177/0363546504269590.
PubMed 15716249Fitzgerald GK, Axe MJ, Snyder-Mackler L. The efficacy of perturbation training in nonoperative anterior cruciate ligament rehabilitation programs for physical active individuals. Phys Ther. 2000 Feb;80(2):128-40.
PubMed 10654060Friederich NF, O'Brien WR. [Gonarthrosis after injury of the anterior cruciate ligament: a multicenter, long-term study]. Z Unfallchir Versicherungsmed. 1993;86(2):81-9. German.
PubMed 8251257Garvey TA, Marks MR, Wiesel SW. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine (Phila Pa 1976). 1989 Sep;14(9):962-4. doi: 10.1097/00007632-198909000-00008.
PubMed 2528826
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Effectiveness of Patients on Break Anterior Cruciate Ligament. Single-Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02699411
- Acronym / sponsor ID
- ACL / European University
- Keywords
- ligament anterior cruciate , dry needling, physioterapy, propioception, knee arthroplasty, vastus medialis.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- European University SpainUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- 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.
We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform techniques proprioception (group a); and twenty patients not be treated with dry needling after ACL surgery, using only proprioceptive exercises to the joint (group B).
Detailed description
It carries out a last fifteen days ECA surgical reconstruction of the anterior cruciate ligament. Twenty individuals in a group to be subjected to a technique of physiotherapy, dry needling were included. (Group A). Another group of twenty patients treated with conservative treatment performed a stability exercises and proprioception (Group B). Forty-six patients will be examined s. None had been previously operated by joint instability and all subjects were previously subjected to a diagnostic study by nuclear magnetic resonance before surgery and the diagnosis was confirmed by additional diagnostic testing. All patients will be evaluated by a physical therapist and Myofascial Trigger Point (PGM) of the vastus muscle will be evaluated.
patients using the following variables are evaluated:
- Pain: Visual Analog Scale (VAS) was used.
- Stiffness and physical function using the WOMAC scale (The Western Ontario and McMaster Universities Arthritis Index.).
- Range of motion of the knee joint: Scale ROM.
- Muscular strength, balance and propiocepción: Star Excursion by Balance Scale Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling | Active comparator | Device: Dry needlingDry needling on the vastus is performed in patients undergoing ACL fortnight after the intervention and then evaluated. REL dry needling while supplies last twenty insertions before treatment, at midnight, a week and five weeks. |
| Stability and propioception | Active comparator | Other: Stability and propioceptionProprioception and stability exercises in patients undergoing ACL fortnight after the intervention and then evaluates performed before treatment, at midnight, a week and five weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- over eighteen and anatomically mature surgically break LCA and valued above using MRI and functional tests to confirm the rupture of the ligament.
Key exclusion criteria (7 listed)
- Patients who did not reach 18 years of age and those over 55,
- postoperative complications
- cause myofascial or neuropathic pain in the lower limb, as lumba-sacral radiculopathy, neuropraxia, neurotmesis, axonotmesis or meralgia paresthetica;
- fibromyalgia.
- hypothyroidism
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 needlingdry needling Travell and Simons | Device | dry needling |
| Stability and propioceptionStart excursion balance test, WOMAC; ROM, EVA. | Other | Stability and propioception |
Primary outcome
Degree range of motion (ROM)
Time frame: 24 hours
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 24 hours
Pain scores visual analog scale (EVA)
Time frame: 24 hours
Scores of STAR BALANCE TEST
Time frame: 24
8 secondary outcomes
Degree range of motion (ROM)
Time frame: 1 week
Degree range of motion (ROM)
Time frame: 5 weeks
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 1 week
Scores ofThe Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 5 weeks
Pain scores visual analog scale (EVA)
Time frame: 1 week
Pain scores visual analog scale (EVA)
Time frame: 5 weeks
Scores STAR BALANCE TEST
Time frame: 1week
Scores STAR BALANCE TEST
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Background: PubMed 12143983Adachi N, Ochi M, Uchio Y, Iwasa J, Ryoke K, Kuriwaka M. Mechanoreceptors in the anterior cruciate ligament contribute to the joint position sense. Acta Orthop Scand. 2002 Jun;73(3):330-4. doi: 10.1080/000164702320155356.
- Background: PubMed 20336305Ahn JH, Chang MJ, Lee YS, Koh KH, Park YS, Eun SS. Non-operative treatment of ACL rupture with mild instability. Arch Orthop Trauma Surg. 2010 Aug;130(8):1001-6. doi: 10.1007/s00402-010-1077-4. Epub 2010 Mar 25.
- Background: PubMed 19452139Alentorn-Geli E, Myer GD, Silvers HJ, Samitier G, Romero D, Lazaro-Haro C, Cugat R. Prevention of non-contact anterior cruciate ligament injuries in soccer players. Part 1: Mechanisms of injury and underlying risk factors. Knee Surg Sports Traumatol Arthrosc. 2009 Jul;17(7):705-29. doi: 10.1007/s00167-009-0813-1. Epub 2009 May 19.
- Background: PubMed 23662122Domingo A, Mayoral O, Monterde S, Santafe MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9.
- Background: PubMed 22543515Baltaci G, Harput G, Haksever B, Ulusoy B, Ozer H. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 Apr;21(4):880-7. doi: 10.1007/s00167-012-2034-2. Epub 2012 Apr 29.
- Background: PubMed 15625515Sbihi A, Franceschi JP, Christel P, Colombet P, Djian P, Bellier G. [Anterior cruciate ligament reconstruction: biomechanical comparison on cadaver specimens using a single or double hamstring technique]. Rev Chir Orthop Reparatrice Appar Mot. 2004 Nov;90(7):643-50. doi: 10.1016/s0035-1040(04)70725-4. French.
- Background: PubMed 8963746Caraffa A, Cerulli G, Projetti M, Aisa G, Rizzo A. Prevention of anterior cruciate ligament injuries in soccer. A prospective controlled study of proprioceptive training. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):19-21. doi: 10.1007/BF01565992.
- Background: PubMed 20949884Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
- Background: PubMed 22790441Delince P, Ghafil D. Anterior cruciate ligament tears: conservative or surgical treatment? Knee Surg Sports Traumatol Arthrosc. 2013 Jul;21(7):1706-7. doi: 10.1007/s00167-012-2134-z. Epub 2012 Jul 13. No abstract available.
- Background: PubMed 10232033Diekstall P, Rauhut F. [Considerations for the indications for anterior cruciate ligament reconstruction. Results of conservative versus operative treatment]. Unfallchirurg. 1999 Mar;102(3):173-81. doi: 10.1007/s001130050390. German.
- Background: PubMed 23115475Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.
- Background: PubMed 15716249Fithian DC, Paxton EW, Stone ML, Luetzow WF, Csintalan RP, Phelan D, Daniel DM. Prospective trial of a treatment algorithm for the management of the anterior cruciate ligament-injured knee. Am J Sports Med. 2005 Mar;33(3):335-46. doi: 10.1177/0363546504269590.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Feasibility of a Mindfulness and Physical Activity Promotion Intervention After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament (ACL) Reconstruction
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
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.
Jorge Velázquez, Sr principal investigator
European 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 Dry needling and Stability and propioception in people with Anterior Cruciate Ligament Reconstruction, run by European University Spain 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 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Velázquez, sr (+34655909940, jorgevelasa@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree range of motion (ROM) (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT02699411, which also lists 47 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 4 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.