Chronic Low-back PainNCT04804228
Efficacy of Electrical Dry Needling in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
A study testing Electrical dry needling and Ischemic compression, analytical stretching and postural habits educational dossier in people with Chronic Low-back Pain, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 30 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Electrical dry needling and Ischemic compression, analytical stretching and postural habits educational dossier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2020to 20 Nov 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 30 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low back pain ≥ 3 months.
- Age between 30 and 67 years old.
- Not being receiving physical therapy.
Who cannot join
- Presence of lumbar stenosis.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroids or oral medication in recent weeks.
- History of spine surgery.
- Contraindication of analgesic electrical therapy.
- Have previously received a treatment of electrical analgesia or exercise.
- Central or peripheral nervous system disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Electrical Dry Needling Versus Traditional Physical Therapy in the Treatment of Active Myofascial Trigger Points in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.
Read the detailed description
A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks.
The control group will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life.
A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up).
The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.
- Conditions
- Chronic Low-back Pain
- Being tested
- Electrical dry needling, Ischemic compression, analytical stretching and postural habits educational dossier
- Keywords
- Electrical dry needling, low back pain, Randomized clinical trial, ischemic compression, analytical stretch
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical dry needlingOther
The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks.
Ischemic compression, analytical stretching and postural habits educational dossierOther
The control group G2, formed by 40 subjects, will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles, 1 weekly session for 6 weeks, in addition to providing them with a training dossier on postural education in their activities of daily life.
| Study group | Role | What they receive |
|---|---|---|
| Electrical dry needling | Experimental | The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks. Receives: Other: Ischemic compression, analytical stretching and postural habits educational dossier |
| Ischemic compression, analytical stretching and postural habits educational dossier | Active comparator | The control group consisting of 40 subjects will undergo an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifid and iliocostal, 1 weekly session for 6 weeks providing a training dossier of postural education in their activities of daily life. Receives: Other: Electrical dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pressure pain threshold by Wagner manual pressure algometer.
Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold).
Measured: At baseline, at 6 weeks and at 2 months
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability
Measured: At baseline, at 6 weeks and at 2 months
Secondary outcomes (9)
Change from baselina in range of motion
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Measured: At baseline, at 6 weeks and at 2 months
Change from baseline in lumbar mobility flexion.
For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
Measured: At baseline, at 6 weeks and at 2 months
Changes in pressure pain threshold by Wagner manual pressure algometer.
Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold).
Measured: At baseline, at 6 weeks and at 2 months
Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.
Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their pain on a 4-point scale ranging from strongly disagree to strongly agree (ranging from 17-68 points).
Measured: At baseline, at 6 weeks and at 2 months
SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.
The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. This scale ranges from 0 (lowest level of functioning) to 100 (highest level)
Measured: At baseline, at 6 weeks and at 2 months
Change from Mcquade Test.
It measures the isometric endurance of trunk flexion muscles.
Measured: At baseline, at 6 weeks and at 2 months
Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.
This questionnaire consists of 24 questions. The total score can range from 0 to 21 points. The higher the total score, the worse the quality of sleep.
Measured: At baseline, at 6 weeks and at 2 months
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome.
Measured: At baseline, at 6 weeks and at 2 months
Change from baseline in pain intensity. Visual analogue scale
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points
Measured: At baseline, at 6 weeks and at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start17 May 2020
- Primary completion17 Aug 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
- Investigators
- Adelaida María Castro-Sánchez, PhD, Principal investigator, Almeria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804228
- Sponsor's protocol ID
- EFM 87/2020
- Status last verified
- Nov 2021
- First submitted
- 14 Jan 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiarotto A, Clijsen R, Fernandez-de-Las-Penas C, Barbero M. Prevalence of Myofascial Trigger Points in Spinal Disorders: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2016 Feb;97(2):316-37. doi: 10.1016/j.apmr.2015.09.021. Epub 2015 Oct 17.
PubMed 26475933Travell JG, Simons DG, Simons LS. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen I. Mitad superior del cuerpo. Madrid: Ed Panamericana. 2007.
Travell JG, Simons DG. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen II. Extremidades inferiores. Madrid: Ed Panamericana. 2007.
Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
PubMed 29864043Dunning J, Butts R, Henry N, Mourad F, Brannon A, Rodriguez H, Young I, Arias-Buria JL, Fernandez-de-Las-Penas C. Electrical dry needling as an adjunct to exercise, manual therapy and ultrasound for plantar fasciitis: A multi-center randomized clinical trial. PLoS One. 2018 Oct 31;13(10):e0205405. doi: 10.1371/journal.pone.0205405. eCollection 2018.
PubMed 30379937Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
PubMed 31354339Rahou-El-Bachiri Y, Navarro-Santana MJ, Gomez-Chiguano GF, Cleland JA, Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Ortega-Santiago R, Plaza-Manzano G. Effects of Trigger Point Dry Needling for the Management of Knee Pain Syndromes: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Jun 29;9(7):2044. doi: 10.3390/jcm9072044.
PubMed 32610659Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.
PubMed 33065273Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.
PubMed 23227789Myburgh C, Larsen AH, Hartvigsen J. A systematic, critical review of manual palpation for identifying myofascial trigger points: evidence and clinical significance. Arch Phys Med Rehabil. 2008 Jun;89(6):1169-76. doi: 10.1016/j.apmr.2007.12.033.
PubMed 18503816Lara-Palomo IC, Antequera-Soler E, Fernandez-Sanchez M, Castro-Sanchez AM, Garcia-Lopez H. Electrical dry needling versus a non-invasive multicomponent intervention in the treatment of myofascial trigger points in patients with chronic low back pain: A randomised clinical trial. Clin Rehabil. 2024 Mar;38(3):347-360. doi: 10.1177/02692155231201589. Epub 2023 Sep 13.
PubMed 37700695Lara-Palomo IC, Gil-Martinez E, Antequera-Soler E, Castro-Sanchez AM, Fernandez-Sanchez M, Garcia-Lopez H. Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain. Trials. 2022 Mar 28;23(1):238. doi: 10.1186/s13063-022-06179-y.
PubMed 35346331
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Electrical Dry Needling Versus Traditional Physical Therapy in the Treatment of Active Myofascial Trigger Points in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT04804228
- Acronym / sponsor ID
- EFM 87/2020
- Conditions
- Chronic Low-back Pain
- Keywords
- Electrical dry needling, low back pain, Randomized clinical trial, ischemic compression, analytical stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 18 Mar 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.
The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.
Detailed description
A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks.
The control group will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life.
A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up).
The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical dry needling | Experimental | Other: Ischemic compression, analytical stretching and postural habits educational dossierThe experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks. |
| Ischemic compression, analytical stretching and postural habits educational dossier | Active comparator | Other: Electrical dry needlingThe control group consisting of 40 subjects will undergo an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifid and iliocostal, 1 weekly session for 6 weeks providing a training dossier of postural education in their activities of daily life. |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low back pain ≥ 3 months.
- Age between 30 and 67 years old.
- Not being receiving physical therapy.
Key exclusion criteria (8 listed)
- Presence of lumbar stenosis.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroids or oral medication in recent weeks.
- History of spine surgery.
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 |
|---|---|---|
| Electrical dry needlingThe experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks. | Other | Ischemic compression, analytical stretching and postural habits educational dossier |
| Ischemic compression, analytical stretching and postural habits educational dossierThe control group G2, formed by 40 subjects, will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles, 1 weekly session for 6 weeks, in addition to providing them with a training dossier on postural education in their activities of daily life. | Other | Electrical dry needling |
Primary outcome
Changes in pressure pain threshold by Wagner manual pressure algometer.
Time frame: At baseline, at 6 weeks and at 2 months
Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold).
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Time frame: At baseline, at 6 weeks and at 2 months
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability
9 secondary outcomes
Change from baselina in range of motion
Time frame: At baseline, at 6 weeks and at 2 months
Change from baseline in lumbar mobility flexion.
Time frame: At baseline, at 6 weeks and at 2 months
Changes in pressure pain threshold by Wagner manual pressure algometer.
Time frame: At baseline, at 6 weeks and at 2 months
Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.
Time frame: At baseline, at 6 weeks and at 2 months
SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.
Time frame: At baseline, at 6 weeks and at 2 months
Change from Mcquade Test.
Time frame: At baseline, at 6 weeks and at 2 months
Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.
Time frame: At baseline, at 6 weeks and at 2 months
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Time frame: At baseline, at 6 weeks and at 2 months
Change from baseline in pain intensity. Visual analogue scale
Time frame: At baseline, at 6 weeks and at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Background: PubMed 26475933Chiarotto A, Clijsen R, Fernandez-de-Las-Penas C, Barbero M. Prevalence of Myofascial Trigger Points in Spinal Disorders: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2016 Feb;97(2):316-37. doi: 10.1016/j.apmr.2015.09.021. Epub 2015 Oct 17.
- BackgroundTravell JG, Simons DG, Simons LS. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen I. Mitad superior del cuerpo. Madrid: Ed Panamericana. 2007.
- BackgroundTravell JG, Simons DG. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen II. Extremidades inferiores. Madrid: Ed Panamericana. 2007.
- Background: PubMed 29864043Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
- Background: PubMed 30379937Dunning J, Butts R, Henry N, Mourad F, Brannon A, Rodriguez H, Young I, Arias-Buria JL, Fernandez-de-Las-Penas C. Electrical dry needling as an adjunct to exercise, manual therapy and ultrasound for plantar fasciitis: A multi-center randomized clinical trial. PLoS One. 2018 Oct 31;13(10):e0205405. doi: 10.1371/journal.pone.0205405. eCollection 2018.
- Background: PubMed 31354339Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
- Background: PubMed 32610659Rahou-El-Bachiri Y, Navarro-Santana MJ, Gomez-Chiguano GF, Cleland JA, Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Ortega-Santiago R, Plaza-Manzano G. Effects of Trigger Point Dry Needling for the Management of Knee Pain Syndromes: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Jun 29;9(7):2044. doi: 10.3390/jcm9072044.
- Background: PubMed 33065273Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.
- Background: PubMed 23227789Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.
- Background: PubMed 18503816Myburgh C, Larsen AH, Hartvigsen J. A systematic, critical review of manual palpation for identifying myofascial trigger points: evidence and clinical significance. Arch Phys Med Rehabil. 2008 Jun;89(6):1169-76. doi: 10.1016/j.apmr.2007.12.033.
- Derived from this study: PubMed 37700695Lara-Palomo IC, Antequera-Soler E, Fernandez-Sanchez M, Castro-Sanchez AM, Garcia-Lopez H. Electrical dry needling versus a non-invasive multicomponent intervention in the treatment of myofascial trigger points in patients with chronic low back pain: A randomised clinical trial. Clin Rehabil. 2024 Mar;38(3):347-360. doi: 10.1177/02692155231201589. Epub 2023 Sep 13.
- Derived from this study: PubMed 35346331Lara-Palomo IC, Gil-Martinez E, Antequera-Soler E, Castro-Sanchez AM, Fernandez-Sanchez M, Garcia-Lopez H. Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain. Trials. 2022 Mar 28;23(1):238. doi: 10.1186/s13063-022-06179-y.
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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.
Adelaida María Castro-Sánchez, PhD principal investigator
Almeria 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 Electrical dry needling and Ischemic compression, analytical stretching and postural habits educational dossier in people with Chronic Low-back Pain, run by Universidad de Almeria 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 10 Dec 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?
Changes in pressure pain threshold by Wagner manual pressure algometer. (time frame: At baseline, at 6 weeks and at 2 months). 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?
On the ClinicalTrials.gov record for NCT04804228, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.