TendinopathyNCT02371902
ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
A study testing MODULITH® SLK, STORZ MEDICAL AG, Switzerland and Cryoultrasound™, Medisport S.r.l., Italy in people with Tendinopathy, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- MODULITH® SLK, STORZ MEDICAL AG, Switzerland and Cryoultrasound™, Medisport S.r.l., Italy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jan 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an age range from 18 to 75 years
- clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months
- intensity of pain of more than 5 on the Visual Analogue Scale (VAS) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test)
- the failure of conservative treatments previously made
- a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study
- capability of filling in the questionnaires and signing the consent form
Who cannot join
- Previous treatment with Cryo-US, ultrasound therapy, ESWT
- The conjoint presence of bilateral or lateral and medial epicondylitis
- Acute infection of the soft tissues or the bones adjacent to the area of treatment
- Local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs
- Pacemaker, pregnancy
- Neoplastic disease
Show all 9Show fewer
- Raynaud's disease, altered thermal and pain sensitivity, or cold intolerance
- Evidence of elbow bursitis, or articular or synovial pathologies; signs of elbow laxity or instability
- Cervicobrachialgia; syndrome of ulnar, radial, or posterior interosseous nerve entrapment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.
Read the detailed description
Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.
- Conditions
- Tendinopathy
- Being tested
- MODULITH® SLK, STORZ MEDICAL AG, Switzerland, Cryoultrasound™, Medisport S.r.l., Italy
- Keywords
- Elbow pain, lateral epicondylitis, conservative treatment, shock wave treatment, therapeutic ultrasound
- Medical subject headings
- Tendinopathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODULITH® SLK, STORZ MEDICAL AG, SwitzerlandDevice
Also called Focused Extracorporeal Shock Wave Therapy, ESWT
Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.
Cryoultrasound™, Medisport S.r.l., ItalyDevice
Also called Therapeutic Ultrasound, Cryo-US therapy
Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Active comparator | Focused Extracorporeal Shock Wave Therapy: 3 sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2 Receives: Device: MODULITH® SLK, STORZ MEDICAL AG, Switzerland |
| Cryo-US Group | Active comparator | Therapeutic cryoultrasound: 12 sessions was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. Receives: Device: Cryoultrasound™, Medisport S.r.l., Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of two points in pain recorded on the VAS
a difference of two points in pain recorded on the VAS during a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test), between the ESWT Group and the Cryo-US Group, in at least one of the periods taken into account.
Measured: 3, 6, or 12 months after the end of treatments
Secondary outcomes (1)
Patients satisfaction based on the Roles and Maudsley score
the number of patients who achieved at least 50% satisfactory results at 3, 6 and 12 months after the treatment. Satisfactory results were described as the sum of the excellent and good scores based on the Roles and Maudsley score.
Measured: 3, 6, or 12 months after the end of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Vetrano, MD, University of Roma La Sapienza
- Investigators
- Maria C Vulpiani, MD, Study chair, La Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371902
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2015
- First submitted
- 12 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.
PubMed 16968862Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999 Feb;81(2):259-78. No abstract available.
PubMed 10073590Galloway MT, Lalley AL, Shearn JT. The role of mechanical loading in tendon development, maintenance, injury, and repair. J Bone Joint Surg Am. 2013 Sep 4;95(17):1620-8. doi: 10.2106/JBJS.L.01004.
PubMed 24005204Haahr JP, Andersen JH. Prognostic factors in lateral epicondylitis: a randomized trial with one-year follow-up in 266 new cases treated with minimal occupational intervention or the usual approach in general practice. Rheumatology (Oxford). 2003 Oct;42(10):1216-25. doi: 10.1093/rheumatology/keg360. Epub 2003 Jun 16.
PubMed 12810936Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
PubMed 23335238Vetrano M, d'Alessandro F, Torrisi MR, Ferretti A, Vulpiani MC, Visco V. Extracorporeal shock wave therapy promotes cell proliferation and collagen synthesis of primary cultured human tenocytes. Knee Surg Sports Traumatol Arthrosc. 2011 Dec;19(12):2159-68. doi: 10.1007/s00167-011-1534-9. Epub 2011 May 27.
PubMed 21617986Leone L, Vetrano M, Ranieri D, Raffa S, Vulpiani MC, Ferretti A, Torrisi MR, Visco V. Extracorporeal Shock Wave Treatment (ESWT) improves in vitro functional activities of ruptured human tendon-derived tenocytes. PLoS One. 2012;7(11):e49759. doi: 10.1371/journal.pone.0049759. Epub 2012 Nov 26.
PubMed 23189160Speed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology (Oxford). 2001 Dec;40(12):1331-6. doi: 10.1093/rheumatology/40.12.1331.
PubMed 11752501Tsai WC, Pang JH, Hsu CC, Chu NK, Lin MS, Hu CF. Ultrasound stimulation of types I and III collagen expression of tendon cell and upregulation of transforming growth factor beta. J Orthop Res. 2006 Jun;24(6):1310-6. doi: 10.1002/jor.20130.
PubMed 16705693Costantino C, Pogliacomi F, Vaienti E. Cryoultrasound therapy and tendonitis in athletes: a comparative evaluation versus laser CO2 and t.e.ca.r. therapy. Acta Biomed. 2005 Apr;76(1):37-41.
PubMed 16116824Costantino C, Vulpiani MC, Romiti D, Vetrano M, Saraceni VM. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med. 2014 Feb;50(1):39-47. Epub 2013 Oct 30.
PubMed 24172641Chung B, Wiley JP, Rose MS. Long-term effectiveness of extracorporeal shockwave therapy in the treatment of previously untreated lateral epicondylitis. Clin J Sport Med. 2005 Sep;15(5):305-12. doi: 10.1097/01.jsm.0000179137.69598.7e.
PubMed 16162988Radwan YA, ElSobhi G, Badawy WS, Reda A, Khalid S. Resistant tennis elbow: shock-wave therapy versus percutaneous tenotomy. Int Orthop. 2008 Oct;32(5):671-7. doi: 10.1007/s00264-007-0379-9. Epub 2007 Jun 6.
PubMed 17551726Rompe JD, Decking J, Schoellner C, Theis C. Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J Sports Med. 2004 Apr-May;32(3):734-43. doi: 10.1177/0363546503261697.
PubMed 15090392Day B. 'Extracorporeal shock wave therapy for lateral epicondylitis--a double blind randomised controlled trial', by Speed CA, Nichols D, Richards C, Humphreys H, Wies JT, Burnet S, Hazleman BL [Journal of Orthopaedic Research 29 (2002) 895-898]. J Orthop Res. 2003 Sep;21(5):960; author reply 961. doi: 10.1016/S0736-0266(03)00045-7. No abstract available.
PubMed 12919888
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
- ClinicalTrials.gov ID
- NCT02371902
- Acronym / sponsor ID
- 1
- Conditions
- Tendinopathy
- Keywords
- Elbow pain, lateral epicondylitis, conservative treatment, shock wave treatment, therapeutic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Feb 2015 (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.
Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.
Detailed description
Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Active comparator | Device: MODULITH® SLK, STORZ MEDICAL AG, SwitzerlandFocused Extracorporeal Shock Wave Therapy: 3 sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2 |
| Cryo-US Group | Active comparator | Device: Cryoultrasound™, Medisport S.r.l., ItalyTherapeutic cryoultrasound: 12 sessions was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- an age range from 18 to 75 years
- clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months
- intensity of pain of more than 5 on the Visual Analogue Scale (VAS) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test)
- the failure of conservative treatments previously made
- a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study
Key exclusion criteria (9 listed)
- Previous treatment with Cryo-US, ultrasound therapy, ESWT
- The conjoint presence of bilateral or lateral and medial epicondylitis
- Acute infection of the soft tissues or the bones adjacent to the area of treatment
- Local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs
- Pacemaker, pregnancy
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 |
|---|---|---|
| MODULITH® SLK, STORZ MEDICAL AG, SwitzerlandAlso: Focused Extracorporeal Shock Wave Therapy, ESWTThree sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment. | Device | ESWT Group |
| Cryoultrasound™, Medisport S.r.l., ItalyAlso: Therapeutic Ultrasound, Cryo-US therapyCryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week). | Device | Cryo-US Group |
Primary outcome
Difference of two points in pain recorded on the VAS
Time frame: 3, 6, or 12 months after the end of treatments
a difference of two points in pain recorded on the VAS during a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test), between the ESWT Group and the Cryo-US Group, in at least one of the periods taken into account.
1 secondary outcome
Patients satisfaction based on the Roles and Maudsley score
Time frame: 3, 6, or 12 months after the end of treatments
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 26 Feb 2015.
- Results publication: PubMed 16968862Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.
- Results publication: PubMed 10073590Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999 Feb;81(2):259-78. No abstract available.
- Results publication: PubMed 24005204Galloway MT, Lalley AL, Shearn JT. The role of mechanical loading in tendon development, maintenance, injury, and repair. J Bone Joint Surg Am. 2013 Sep 4;95(17):1620-8. doi: 10.2106/JBJS.L.01004.
- Results publication: PubMed 12810936Haahr JP, Andersen JH. Prognostic factors in lateral epicondylitis: a randomized trial with one-year follow-up in 266 new cases treated with minimal occupational intervention or the usual approach in general practice. Rheumatology (Oxford). 2003 Oct;42(10):1216-25. doi: 10.1093/rheumatology/keg360. Epub 2003 Jun 16.
- Results publication: PubMed 23335238Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
- Results publication: PubMed 21617986Vetrano M, d'Alessandro F, Torrisi MR, Ferretti A, Vulpiani MC, Visco V. Extracorporeal shock wave therapy promotes cell proliferation and collagen synthesis of primary cultured human tenocytes. Knee Surg Sports Traumatol Arthrosc. 2011 Dec;19(12):2159-68. doi: 10.1007/s00167-011-1534-9. Epub 2011 May 27.
- Results publication: PubMed 23189160Leone L, Vetrano M, Ranieri D, Raffa S, Vulpiani MC, Ferretti A, Torrisi MR, Visco V. Extracorporeal Shock Wave Treatment (ESWT) improves in vitro functional activities of ruptured human tendon-derived tenocytes. PLoS One. 2012;7(11):e49759. doi: 10.1371/journal.pone.0049759. Epub 2012 Nov 26.
- Results publication: PubMed 11752501Speed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology (Oxford). 2001 Dec;40(12):1331-6. doi: 10.1093/rheumatology/40.12.1331.
- Results publication: PubMed 16705693Tsai WC, Pang JH, Hsu CC, Chu NK, Lin MS, Hu CF. Ultrasound stimulation of types I and III collagen expression of tendon cell and upregulation of transforming growth factor beta. J Orthop Res. 2006 Jun;24(6):1310-6. doi: 10.1002/jor.20130.
- Results publication: PubMed 16116824Costantino C, Pogliacomi F, Vaienti E. Cryoultrasound therapy and tendonitis in athletes: a comparative evaluation versus laser CO2 and t.e.ca.r. therapy. Acta Biomed. 2005 Apr;76(1):37-41.
- Results publication: PubMed 24172641Costantino C, Vulpiani MC, Romiti D, Vetrano M, Saraceni VM. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med. 2014 Feb;50(1):39-47. Epub 2013 Oct 30.
- Results publication: PubMed 16162988Chung B, Wiley JP, Rose MS. Long-term effectiveness of extracorporeal shockwave therapy in the treatment of previously untreated lateral epicondylitis. Clin J Sport Med. 2005 Sep;15(5):305-12. doi: 10.1097/01.jsm.0000179137.69598.7e.
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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.
Maria C Vulpiani, MD study chair
La Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MODULITH® SLK, STORZ MEDICAL AG, Switzerland and Cryoultrasound™, Medisport S.r.l., Italy in people with Tendinopathy, run by University of Roma La Sapienza at 1 site in Italy.
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 6 inclusion and 9 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 26 Feb 2015. 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 Italy. 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?
Difference of two points in pain recorded on the VAS (time frame: 3, 6, or 12 months after the end of treatments). 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 NCT02371902, which also lists 16 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 26 Feb 2015.