EpicondylitisNCT04729400
Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.
A study testing Vacuum Myofascial Therapy device, physical therapy program and Therapeutic Percutaneous Electrolysis in people with Epicondylitis, run by University of Cadiz at 1 site in Spain.
Trial summary
The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epicondylitis
- What is being tested?
- Vacuum Myofascial Therapy device, physical therapy program and Therapeutic Percutaneous Electrolysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.
Who cannot join
- Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with electrolysis and Vacuum Myofascial Therapy Device a month earlier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Electrolysis and Vacuum Myofascial Therapy Device in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.
The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.
Read the detailed description
Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home and the control group will be included 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
- Conditions
- Epicondylitis
- Being tested
- Vacuum Myofascial Therapy device, physical therapy program, Therapeutic Percutaneous Electrolysis, ultrasound pulsatil therapy (US) and massage
- Keywords
- Tendinopathy, Electrolysis, Exercise, Dry needing, massage, cupping, vacuum, negative pressure
- Medical subject headings
- Tendinopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Myofascial Therapy deviceDevice
Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.
physical therapy programOther
The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
Therapeutic Percutaneous ElectrolysisProcedure or surgery
Therapeutic Percutaneous Electrolysis
ultrasound pulsatil therapy (US) and massageProcedure or surgery
ultrasound pulsatil therapy (US) and massage
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home. Receives: Device: Vacuum Myofascial Therapy device; Procedure: Therapeutic Percutaneous Electrolysis |
| CONTROL GROUP | Experimental | The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home. Receives: Other: physical therapy program; Procedure: ultrasound pulsatil therapy (US) and massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of pain in epicondylitis
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Measured: Baseline
Secondary outcomes (5)
The intensity of pain in epicondylitis
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Measured: Four and twelve weeks
Active elbow range of motion
Measured by a two branches egoniomter
Measured: Baseline,four and twelve weeks
Pressure pain thresholds in epicondylitis trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)
Measured: Baseline, four and twelve weeks
Questionnaire SF 12
The multidimensional health related quality of life
Measured: Baseline,four and twelve weeks
Scale PRTEE
PRTEE is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Measured: Baseline,four weeks and Twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start10 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for EpicondylitisStudies 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
- A specialist physician will be diagnosed the epicondylitis
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Rodriguez Huguet, University of Cadiz
- Investigators
- manuel Rodríguez Huguet, Physiotherapy, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729400
- Sponsor's protocol ID
- Elctrolysis and vacuum
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.
PubMed 25122629Walz DM, Newman JS, Konin GP, Ross G. Epicondylitis: pathogenesis, imaging, and treatment. Radiographics. 2010 Jan;30(1):167-84. doi: 10.1148/rg.301095078.
PubMed 20083592Rodriguez-Huguet M, Gongora-Rodriguez J, Lomas-Vega R, Martin-Valero R, Diaz-Fernandez A, Obrero-Gaitan E, Ibanez-Vera AJ, Rodriguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7):2068. doi: 10.3390/jcm9072068.
PubMed 32630241Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
PubMed 26649058Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.
PubMed 28135129Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.
PubMed 32545583Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
PubMed 30397006Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23.
PubMed 19423657Leem J. Long-term effect of cupping for chronic neck pain. Integr Med Res. 2014 Dec;3(4):217-219. doi: 10.1016/j.imr.2014.10.001. Epub 2014 Oct 14. No abstract available.
PubMed 28664101Huber R, Emerich M, Braeunig M. Cupping - is it reproducible? Experiments about factors determining the vacuum. Complement Ther Med. 2011 Apr;19(2):78-83. doi: 10.1016/j.ctim.2010.12.006. Epub 2011 Jan 22.
PubMed 21549258Lauche R, Cramer H, Hohmann C, Choi KE, Rampp T, Saha FJ, Musial F, Langhorst J, Dobos G. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study. Evid Based Complement Alternat Med. 2012;2012:429718. doi: 10.1155/2012/429718. Epub 2011 Dec 7.
PubMed 22203873Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.
PubMed 29794282Rodriguez-Huguet M, Rodriguez-Huguet P, Lomas-Vega R, Ibanez-Vera AJ, Rodriguez-Almagro D. Vacuum myofascial therapy device for non-specific neck pain. A single blind randomized clinical trial. Complement Ther Med. 2020 Aug;52:102449. doi: 10.1016/j.ctim.2020.102449. Epub 2020 May 30.
PubMed 32951712Gunduz R, Malas FU, Borman P, Kocaoglu S, Ozcakar L. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. 2012 May;31(5):807-12. doi: 10.1007/s10067-012-1939-y. Epub 2012 Jan 27.
PubMed 22278162Rodriguez-Huguet M, Rodriguez-Almagro D, Rosety-Rodriguez MA, Vinolo-Gil MJ, Molina-Jimenez J, Gongora-Rodriguez J. Pulsed negative pressure myofascial vacuum therapy and percutaneous electrolysis in the treatment of lateral epicondylalgia: A single-blind randomized controlled trial. J Hand Ther. 2024 Oct-Dec;37(4):644-652. doi: 10.1016/j.jht.2024.02.003. Epub 2024 Mar 6.
PubMed 38453573
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Electrolysis and Vacuum Myofascial Therapy Device in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04729400
- Acronym / sponsor ID
- Elctrolysis and vacuum
- Conditions
- Epicondylitis
- Keywords
- Tendinopathy, Electrolysis, Exercise, Dry needing, massage, cupping, vacuum, negative pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.
Detailed description
Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home and the control group will be included 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A specialist physician will be diagnosed the epicondylitis
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Vacuum Myofascial Therapy device, Procedure: Therapeutic Percutaneous ElectrolysisTherapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home. |
| CONTROL GROUP | Experimental | Other: physical therapy program, Procedure: ultrasound pulsatil therapy (US) and massageThe multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.
Key exclusion criteria (1 listed)
- Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with electrolysis and Vacuum Myofascial Therapy Device a month earlier
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 |
|---|---|---|
| Vacuum Myofascial Therapy deviceTherapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home. | Device | Experimental group |
| physical therapy programThe multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home. | Other | CONTROL GROUP |
| Therapeutic Percutaneous ElectrolysisTherapeutic Percutaneous Electrolysis | Procedure or surgery | Experimental group |
| ultrasound pulsatil therapy (US) and massageultrasound pulsatil therapy (US) and massage | Procedure or surgery | CONTROL GROUP |
Primary outcome
The intensity of pain in epicondylitis
Time frame: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
5 secondary outcomes
The intensity of pain in epicondylitis
Time frame: Four and twelve weeks
Active elbow range of motion
Time frame: Baseline,four and twelve weeks
Pressure pain thresholds in epicondylitis trigger points
Time frame: Baseline, four and twelve weeks
Questionnaire SF 12
Time frame: Baseline,four and twelve weeks
Scale PRTEE
Time frame: Baseline,four weeks and Twelve weeks.
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 25 Feb 2022.
- Background: PubMed 25122629Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.
- Background: PubMed 20083592Walz DM, Newman JS, Konin GP, Ross G. Epicondylitis: pathogenesis, imaging, and treatment. Radiographics. 2010 Jan;30(1):167-84. doi: 10.1148/rg.301095078.
- Background: PubMed 32630241Rodriguez-Huguet M, Gongora-Rodriguez J, Lomas-Vega R, Martin-Valero R, Diaz-Fernandez A, Obrero-Gaitan E, Ibanez-Vera AJ, Rodriguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7):2068. doi: 10.3390/jcm9072068.
- Background: PubMed 26649058Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
- Background: PubMed 28135129Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.
- Background: PubMed 32545583Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.
- Background: PubMed 30397006Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
- Background: PubMed 19423657Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23.
- Background: PubMed 28664101Leem J. Long-term effect of cupping for chronic neck pain. Integr Med Res. 2014 Dec;3(4):217-219. doi: 10.1016/j.imr.2014.10.001. Epub 2014 Oct 14. No abstract available.
- Background: PubMed 21549258Huber R, Emerich M, Braeunig M. Cupping - is it reproducible? Experiments about factors determining the vacuum. Complement Ther Med. 2011 Apr;19(2):78-83. doi: 10.1016/j.ctim.2010.12.006. Epub 2011 Jan 22.
- Background: PubMed 22203873Lauche R, Cramer H, Hohmann C, Choi KE, Rampp T, Saha FJ, Musial F, Langhorst J, Dobos G. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study. Evid Based Complement Alternat Med. 2012;2012:429718. doi: 10.1155/2012/429718. Epub 2011 Dec 7.
- Background: PubMed 29794282Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.
Related trials for Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
manuel Rodríguez Huguet, Physiotherapy principal investigator
University of Cádiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Myofascial Therapy device, physical therapy program and Therapeutic Percutaneous Electrolysis in people with Epicondylitis, run by University of Cadiz 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 1 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 25 Feb 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?
The intensity of pain in epicondylitis (time frame: Baseline). 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 NCT04729400, which also lists 15 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 25 Feb 2022.