EpicondylitisNCT05853029
Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
A study testing Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy in people with Epicondylitis, run by Mennallah Ahmed Mohamed Anwar Elgendy.
Trial summary
1. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain. 2. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epicondylitis
- What is being tested?
- Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age between 18 - 55 years old.
- BMI < 35
- Males and Females
- Painful chronic tennis elbow during at least 3 previous months identified by positive Mill"s, Maudsley"s and Cozen"s tests.
- Painful palpation of the lateral epicondyle.
- Painful resisted middle finger and wrist extension (Maudsley's test).
Who cannot join
- Local infection.
- Malignancy.
- Elbow arthritis or instability.
- Pronator-Teres syndrome.
- Generalized polyarthritis.
- Neurological disorders (Stroke and Parkinson"s disease).
Show all 9Show fewer
- Radial-nerve entrapment.
- Physical therapy and/or a corticosteroid injection administered within the previous six weeks.
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
NEVEEN Abdelraoof, Prof. Dr contact
About this study
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain.
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding hand function.
- 1. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding grip strength.
Read the detailed description
Lateral epicondylitis, also known as "tennis elbow", is a common disease present in clinical practice. It affects 1% to 3% in the general population which can reach up to 29% in certain occupations with repetitive wrist movements. It can cause a significant functional decline with a great psychological and economic impact.
Major symptoms include decreased grip and upper-extremity strength along with pain and inflammation originating from the lateral elbow. The pathogenesis of lateral epicondylitis is still controversial, but it is known that not only the tendon of the extensor carpi radialis brevis (ECRB) muscle but also the annular ligament, lateral capsule, radial nerve and some bands of the extensor digitorum communis muscle are involved.
It was originally thought that the cause of lateral epicondylitis was an inflammatory process, which would then result in the symptoms. However, histological studies have demonstrated that, through repetitive injuries at this site, there is a degenerative process and a failure of repair in the ECRB tendon. This is more pronounced than inflammation in other structures.
A variety of therapeutic techniques have been proposed for the appropriate management of patients with lateral elbow tendinopathy including exercise, orthotics, manual therapy, passive modalities, acupuncture or a combination of them.
However, the effectiveness of each treatment option remains debatable. Extracorporeal shockwave therapy (ESWT) is a popular method in the management of common tendinopathies and has been proposed as an effective supplement to other non-invasive therapies. There are two types of extracorporeal shockwave therapy: focused shockwave therapy (FSWT) and radial shockwave therapy (RSWT). Waves that are generated for focused and radial ESWT have very different physical characteristics.
FSWT has focused on a pressure area concentrated on a definite place, and can be adjusted at definite depths in the selected tissues, where the higher pressure is touched. Focused type of shockwave is directed by the reflection at definitive areas into the body of patients, and the waves are generated from a wide arc, hence the amount of energy discrete is minimal at the point of real wave generation. The radial shock wave therapy has been attributed to the scattering pressure zone of RSWT apparatus, which arrives at the source as the highest pressure, and didn't require a certain distance in human body and the omitted waves radiate within the tissues, and influence a large area, but they do not deeply reach the thick tissues as that in focused wave therapy, therefore RSWT is effective for treating superficial lesions that assist the deep-tissue stimulation like backs and muscles.
- Conditions
- Epicondylitis
- Being tested
- Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
- Keywords
- Shockwave therapy, Lateral epicondylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapyCombination product
Also called Conventional therapy for tennis elbow
The device used for management is from Storz-Medical company; Duolith-SD1 with focused and radial module.
- Conventional therapy in the form of eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group (1): Twenty patients will receive 2000 pulses of Focused shock wave therapy with (4 Hz; 0.2 millijoule (mJ)/mm2) in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015). Receives: Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy |
| Group B | Experimental | Group (2): Twenty patients will receive both 2000 pulses of (Focused shockwave therapy with (4 Hz; 0.2 mJ/mm2) and 2000 pulses of Radial shockwave therapy with (8 Hz, 2.5 bars) )= combined shockwave therapy in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015). Receives: Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy |
| Group C | Experimental | Group (3): Control group of twenty patients that will only receive conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Receives: Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment.
amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain
Measured: 3 months
rated-tennis-elbow-questionnaire for hand function assessment
score from that questionnaire Pain Subscale - Add up 5 items. Best score = 0; Worst score = 50 Specific Activities - Add up 6 items Best Score = 0; Worst Score = 60 Usual Activities - Add up 4 items items Best Score = 0; Worst Score = 40 Function Subscale - (Specific Activities + Usual Activities) /2 Best score = 0; Worst score = 50 Total Score = Pain Subscale + Function Subscale Best Score = 0; Worst Score = 100 (pain and disability contribute equally to score)
Measured: 3 months
Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101
Device used to test the hand grib strength
Measured: 3 months
Secondary outcomes (3)
For patient selection Mill's Test
Patient's lateral epicondyle palpated with one hand, while pronating the patient's forearm, fully flexing the wrist, the elbow extended. Decided it a positive test when we found pain in the area of insertion at lateral epicondyle.
Measured: Before the study for patient selection
Maudsley's test
The examiner resists extension of the 3rd digit of the hand, stressing the extensor digitorum muscle and tendon, while palpating the patient's lateral epicondyle. A positive test is indicated by pain over the lateral epicondyle of the humerus.
Measured: Before the study for patient selection
Cozen's Test
To perform Cozen's test,patient seated, the therapist stabilizes the patient's elbow in 90 degrees of flexion with one hand while palpating over the lateral epicondyle. The other hand positions the patient's hand into radial deviation and forearm pronation while the patient is asked to resisted wrist extension in this position against manual resistance of the therapist. The test is considered positive if it produces pain or reproduction of other symptoms in the area of the lateral epicondyle.
Measured: Before the study for patient selection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study startAug 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mennallah Ahmed Mohamed Anwar Elgendy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mennallah Ahmed Mohamed Anwar Elgendy, Cairo University
- Investigators
- RANIA REDA, A. Prof Dr., Study director, cairo uniNEVEEN Abdelraoof, Prof. Dr., Study director, cairo uniMenna allah Elgendy, Bachelor, Principal investigator, cairo uniTitus Bertolini, Dr. med., Study director, Medicum clinics Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853029
- Sponsor's protocol ID
- Shockwave on tennis elbow
- Status last verified
- Aug 2023
- First submitted
- 26 Mar 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levin D, Nazarian LN, Miller TT, O'Kane PL, Feld RI, Parker L, McShane JM. Lateral epicondylitis of the elbow: US findings. Radiology. 2005 Oct;237(1):230-4. doi: 10.1148/radiol.2371040784. Epub 2005 Aug 18.
PubMed 16118152Aben A, De Wilde L, Hollevoet N, Henriquez C, Vandeweerdt M, Ponnet K, Van Tongel A. Tennis elbow: associated psychological factors. J Shoulder Elbow Surg. 2018 Mar;27(3):387-392. doi: 10.1016/j.jse.2017.11.033.
PubMed 29433642Abo Al-Khair MA, El Khouly RM, Khodair SA, Al Sattar Elsergany MA, Hussein MI, Eldin Mowafy ME. Focused, radial and combined shock wave therapy in treatment of calcific shoulder tendinopathy. Phys Sportsmed. 2021 Nov;49(4):480-487. doi: 10.1080/00913847.2020.1856633. Epub 2020 Dec 6.
PubMed 33283581Baker CL Jr, Baker CL 3rd. Long-term follow-up of arthroscopic treatment of lateral epicondylitis. Am J Sports Med. 2008 Feb;36(2):254-60. doi: 10.1177/0363546507311599.
PubMed 18202296Bisset LM, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015 Oct;61(4):174-81. doi: 10.1016/j.jphys.2015.07.015. Epub 2015 Sep 8. No abstract available.
PubMed 26361816Chang KV, Chen SY, Chen WS, Tu YK, Chien KL. Comparative effectiveness of focused shock wave therapy of different intensity levels and radial shock wave therapy for treating plantar fasciitis: a systematic review and network meta-analysis. Arch Phys Med Rehabil. 2012 Jul;93(7):1259-68. doi: 10.1016/j.apmr.2012.02.023. Epub 2012 Mar 12.
PubMed 22421623Cohen M, da Rocha Motta Filho G. LATERAL EPICONDYLITIS OF THE ELBOW. Rev Bras Ortop. 2015 Dec 8;47(4):414-20. doi: 10.1016/S2255-4971(15)30121-X. eCollection 2012 Jul-Aug.
PubMed 27047843Hastie G, Soufi M, Wilson J, Roy B. Platelet rich plasma injections for lateral epicondylitis of the elbow reduce the need for surgical intervention. J Orthop. 2018 Jan 31;15(1):239-241. doi: 10.1016/j.jor.2018.01.046. eCollection 2018 Mar.
PubMed 29657476Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.
PubMed 18832341Ilieva EM, Minchev RM, Petrova NS. Radial shock wave therapy in patients with lateral epicondylitis. Folia Med (Plovdiv). 2012 Jul-Sep;54(3):35-41. doi: 10.2478/v10153-011-0095-5.
PubMed 23270205Karanasios S, Tsamasiotis GK, Michopoulos K, Sakellari V, Gioftsos G. Clinical effectiveness of shockwave therapy in lateral elbow tendinopathy: systematic review and meta-analysis. Clin Rehabil. 2021 Oct;35(10):1383-1398. doi: 10.1177/02692155211006860. Epub 2021 Apr 4.
PubMed 33813913Korakakis V, Whiteley R, Tzavara A, Malliaropoulos N. The effectiveness of extracorporeal shockwave therapy in common lower limb conditions: a systematic review including quantification of patient-rated pain reduction. Br J Sports Med. 2018 Mar;52(6):387-407. doi: 10.1136/bjsports-2016-097347. Epub 2017 Sep 27.
PubMed 28954794Krol P, Franek A, Durmala J, Blaszczak E, Ficek K, Krol B, Detko E, Wnuk B, Bialek L, Taradaj J. Focused and Radial Shock Wave Therapy in the Treatment of Tennis Elbow: A Pilot Randomised Controlled Study. J Hum Kinet. 2015 Oct 14;47:127-35. doi: 10.1515/hukin-2015-0068. eCollection 2015 Sep 29.
PubMed 26557197Lian J, Mohamadi A, Chan JJ, Hanna P, Hemmati D, Lechtig A, Nazarian A. Comparative Efficacy and Safety of Nonsurgical Treatment Options for Enthesopathy of the Extensor Carpi Radialis Brevis: A Systematic Review and Meta-analysis of Randomized Placebo-Controlled Trials. Am J Sports Med. 2019 Oct;47(12):3019-3029. doi: 10.1177/0363546518801914. Epub 2018 Oct 31.
PubMed 30380334Savoie FH 3rd, VanSice W, O'Brien MJ. Arthroscopic tennis elbow release. J Shoulder Elbow Surg. 2010 Mar;19(2 Suppl):31-6. doi: 10.1016/j.jse.2009.12.016.
PubMed 20188266
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05853029
- Acronym / sponsor ID
- Shockwave on tennis elbow
- Conditions
- Epicondylitis
- Keywords
- Shockwave therapy, Lateral epicondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mennallah Ahmed Mohamed Anwar ElgendyUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 10 May 2023 (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.
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain.
- To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding hand function.
- 1. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding grip strength.
Detailed description
Lateral epicondylitis, also known as "tennis elbow", is a common disease present in clinical practice. It affects 1% to 3% in the general population which can reach up to 29% in certain occupations with repetitive wrist movements. It can cause a significant functional decline with a great psychological and economic impact.
Major symptoms include decreased grip and upper-extremity strength along with pain and inflammation originating from the lateral elbow. The pathogenesis of lateral epicondylitis is still controversial, but it is known that not only the tendon of the extensor carpi radialis brevis (ECRB) muscle but also the annular ligament, lateral capsule, radial nerve and some bands of the extensor digitorum communis muscle are involved.
It was originally thought that the cause of lateral epicondylitis was an inflammatory process, which would then result in the symptoms. However, histological studies have demonstrated that, through repetitive injuries at this site, there is a degenerative process and a failure of repair in the ECRB tendon. This is more pronounced than inflammation in other structures.
A variety of therapeutic techniques have been proposed for the appropriate management of patients with lateral elbow tendinopathy including exercise, orthotics, manual therapy, passive modalities, acupuncture or a combination of them.
However, the effectiveness of each treatment option remains debatable. Extracorporeal shockwave therapy (ESWT) is a popular method in the management of common tendinopathies and has been proposed as an effective supplement to other non-invasive therapies. There are two types of extracorporeal shockwave therapy: focused shockwave therapy (FSWT) and radial shockwave therapy (RSWT). Waves that are generated for focused and radial ESWT have very different physical characteristics.
FSWT has focused on a pressure area concentrated on a definite place, and can be adjusted at definite depths in the selected tissues, where the higher pressure is touched. Focused type of shockwave is directed by the reflection at definitive areas into the body of patients, and the waves are generated from a wide arc, hence the amount of energy discrete is minimal at the point of real wave generation. The radial shock wave therapy has been attributed to the scattering pressure zone of RSWT apparatus, which arrives at the source as the highest pressure, and didn't require a certain distance in human body and the omitted waves radiate within the tissues, and influence a large area, but they do not deeply reach the thick tissues as that in focused wave therapy, therefore RSWT is effective for treating superficial lesions that assist the deep-tissue stimulation like backs and muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapyGroup (1): Twenty patients will receive 2000 pulses of Focused shock wave therapy with (4 Hz; 0.2 millijoule (mJ)/mm2) in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015). |
| Group B | Experimental | Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapyGroup (2): Twenty patients will receive both 2000 pulses of (Focused shockwave therapy with (4 Hz; 0.2 mJ/mm2) and 2000 pulses of Radial shockwave therapy with (8 Hz, 2.5 bars) )= combined shockwave therapy in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015). |
| Group C | Experimental | Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapyGroup (3): Control group of twenty patients that will only receive conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient age between 18 - 55 years old.
- BMI < 35
- Males and Females
- Painful chronic tennis elbow during at least 3 previous months identified by positive Mill"s, Maudsley"s and Cozen"s tests.
- Painful palpation of the lateral epicondyle.
Key exclusion criteria (9 listed)
- Local infection.
- Malignancy.
- Elbow arthritis or instability.
- Pronator-Teres syndrome.
- Generalized polyarthritis.
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 |
|---|---|---|
| Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapyAlso: Conventional therapy for tennis elbowThe device used for management is from Storz-Medical company; Duolith-SD1 with focused and radial module. - Conventional therapy in the form of eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). | Combination product | Group A, Group B, Group C |
Primary outcome
Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment.
Time frame: 3 months
amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain
rated-tennis-elbow-questionnaire for hand function assessment
Time frame: 3 months
score from that questionnaire Pain Subscale - Add up 5 items. Best score = 0; Worst score = 50 Specific Activities - Add up 6 items Best Score = 0; Worst Score = 60 Usual Activities - Add up 4 items items Best Score = 0; Worst Score = 40 Function Subscale - (Specific Activities + Usual Activities) /2 Best score = 0; Worst score = 50 Total Score = Pain Subscale + Function Subscale Best Score = 0; Worst Score = 100 (pain and disability contribute equally to score)
Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101
Time frame: 3 months
Device used to test the hand grib strength
3 secondary outcomes
For patient selection Mill's Test
Time frame: Before the study for patient selection
Maudsley's test
Time frame: Before the study for patient selection
Cozen's Test
Time frame: Before the study for patient selection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 16118152Levin D, Nazarian LN, Miller TT, O'Kane PL, Feld RI, Parker L, McShane JM. Lateral epicondylitis of the elbow: US findings. Radiology. 2005 Oct;237(1):230-4. doi: 10.1148/radiol.2371040784. Epub 2005 Aug 18.
- Background: PubMed 29433642Aben A, De Wilde L, Hollevoet N, Henriquez C, Vandeweerdt M, Ponnet K, Van Tongel A. Tennis elbow: associated psychological factors. J Shoulder Elbow Surg. 2018 Mar;27(3):387-392. doi: 10.1016/j.jse.2017.11.033.
- Background: PubMed 33283581Abo Al-Khair MA, El Khouly RM, Khodair SA, Al Sattar Elsergany MA, Hussein MI, Eldin Mowafy ME. Focused, radial and combined shock wave therapy in treatment of calcific shoulder tendinopathy. Phys Sportsmed. 2021 Nov;49(4):480-487. doi: 10.1080/00913847.2020.1856633. Epub 2020 Dec 6.
- Background: PubMed 18202296Baker CL Jr, Baker CL 3rd. Long-term follow-up of arthroscopic treatment of lateral epicondylitis. Am J Sports Med. 2008 Feb;36(2):254-60. doi: 10.1177/0363546507311599.
- Background: PubMed 26361816Bisset LM, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015 Oct;61(4):174-81. doi: 10.1016/j.jphys.2015.07.015. Epub 2015 Sep 8. No abstract available.
- Background: PubMed 22421623Chang KV, Chen SY, Chen WS, Tu YK, Chien KL. Comparative effectiveness of focused shock wave therapy of different intensity levels and radial shock wave therapy for treating plantar fasciitis: a systematic review and network meta-analysis. Arch Phys Med Rehabil. 2012 Jul;93(7):1259-68. doi: 10.1016/j.apmr.2012.02.023. Epub 2012 Mar 12.
- Background: PubMed 27047843Cohen M, da Rocha Motta Filho G. LATERAL EPICONDYLITIS OF THE ELBOW. Rev Bras Ortop. 2015 Dec 8;47(4):414-20. doi: 10.1016/S2255-4971(15)30121-X. eCollection 2012 Jul-Aug.
- Background: PubMed 29657476Hastie G, Soufi M, Wilson J, Roy B. Platelet rich plasma injections for lateral epicondylitis of the elbow reduce the need for surgical intervention. J Orthop. 2018 Jan 31;15(1):239-241. doi: 10.1016/j.jor.2018.01.046. eCollection 2018 Mar.
- Background: PubMed 18832341Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.
- Background: PubMed 23270205Ilieva EM, Minchev RM, Petrova NS. Radial shock wave therapy in patients with lateral epicondylitis. Folia Med (Plovdiv). 2012 Jul-Sep;54(3):35-41. doi: 10.2478/v10153-011-0095-5.
- Background: PubMed 33813913Karanasios S, Tsamasiotis GK, Michopoulos K, Sakellari V, Gioftsos G. Clinical effectiveness of shockwave therapy in lateral elbow tendinopathy: systematic review and meta-analysis. Clin Rehabil. 2021 Oct;35(10):1383-1398. doi: 10.1177/02692155211006860. Epub 2021 Apr 4.
- Background: PubMed 28954794Korakakis V, Whiteley R, Tzavara A, Malliaropoulos N. The effectiveness of extracorporeal shockwave therapy in common lower limb conditions: a systematic review including quantification of patient-rated pain reduction. Br J Sports Med. 2018 Mar;52(6):387-407. doi: 10.1136/bjsports-2016-097347. Epub 2017 Sep 27.
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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.
NEVEEN Abdelraoof, Prof. Dr contact
RANIA REDA, A. Prof Dr. study director
cairo uni
NEVEEN Abdelraoof, Prof. Dr. study director
cairo uni
Menna allah Elgendy, Bachelor principal investigator
cairo uni
Questions about this trial
What is this clinical trial studying?
A study testing Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy in people with Epicondylitis, run by Mennallah Ahmed Mohamed Anwar Elgendy.
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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Menna allah Elgendy, Bachelor (01010334319, Mennaallahelgendy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment. (time frame: 3 months). The study lists 3 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 NCT05853029, which also lists 26 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 16 Aug 2023.