Tennis ElbowPhase 2/3NCT00947765
A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis
A Phase 2/3 study testing Autologous blood injection and Local corticosteroid injection in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Dojode, Chetan M., MBBS, MS at 1 site in India.
Trial summary
Lateral epicondylitis, is a common problem encountered in the orthopaedic practice. Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow, Epicondylitis, Lateral Humeral
- What is being tested?
- Autologous blood injection and Local corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2007to Jun 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cases of lateral epicondylitis.
- Men and women above fifteen years of age.
Who cannot join
- Patients receiving steroid injections within three months before blood injection.
- A history of substantial trauma.
- Previously treated by surgery for lateral epicondylitis.
- Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.
Trial locations and contacts
1 site in 1 country.
India1 site
Jawaharlal Nehru Medical College. KLES Dr.Prabhakar Kore Hospital and Medical Research Center.
Belagavi, Karnataka, 590010
About this study
Official title: Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis.
Lateral epicondylitis, is a common problem encountered in the orthopaedic practice. Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. Beneficial effects of local corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens show lack of any inflammatory process. Recently an injection of "autologous blood injection" has been reported to be effective for both intermediate and long term outcomes. It is hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to induce healing cascade. The objective of the study is to evaluate the efficacy of autologous blood injection versus local corticosteroid injection in the management of lateral epicondylitis.
Read the detailed description
Much controversy has been there over the pathophysiology and there is not enough scientific evidence to favour any particular type of treatment for acute lateral epicondylitis. Currently degeneration of the origin of the extensor carpi radialis brevis (ECRB), repeated micro trauma and incomplete healing response has been accepted as the cause of lateral epicondylitis by most of the researchers.
Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. There are numerous treatment modalities for lateral epicondylitis both conservative and operative. Most conservative modalities such as local corticosteroid injection have focused on suppressing inflammatory process that does not actually exist. A recent review article concluded that for short term outcomes (6 weeks), statistically significant and clinically relevant differences were found on pain and global improvement with corticosteroid injection compared to placebo, local anaesthetic, or other conservative treatments. For intermediate (6 weeks to 6 months) and long term outcomes (more than 6 months), no statistically significant or clinically relevant results in favour of corticosteroid injections were found. So it is not possible to draw a firm conclusion on the effectiveness of corticosteroid injection.
Recently an injection of autologous blood has been reported to be effective for both intermediate and long term outcomes for the treatment of lateral epicondylitis. There was a significant decrease in pain. It is hypothesized that mitogens such as platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to cause angiogenesis. A specific humoral mediator may promote the healing cascade in the treatment of tendinosis as well. These growth factors trigger stem cell recruitment, increase local vascularity and directly stimulate the production of collagen by tendon sheath fibroblasts.
Autologous blood was selected as the medium for injection because (1) its application is minimally traumatic, (2) it has a reduced risk for immune-mediated rejection, devoid of potential complications such as hypoglycemia, skin atrophy, tendon tears associated with corticosteroid injection (3) it is simple to acquire and prepare, easy to carry out as outpatient procedure and (4) it is inexpensive.
There are very few studies done to evaluate injection of autologous blood for lateral epicondylitis as treatment modality. Hence it is evaluated by comparing with the corticosteroid injection which is a commonly practiced conservative treatment modality.
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Being tested
- Autologous blood injection, Local corticosteroid injection
- Keywords
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood injectionBiological
Also called autologous blood drawn from peripheral vein.
Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique.
Local corticosteroid injectionDrug
Also called Methyl prednisolone acetate 80mg
Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique
| Study group | Role | What they receive |
|---|---|---|
| Autologous blood injection group | Experimental | This is the study group in whom autologous blood injection was injected at lateral epicondylitis site. Receives: Biological: Autologous blood injection |
| Local corticosteroid injection group | Active comparator | This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site. Receives: Drug: Local corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (at 1 Week): Visual Analogue Scale(0 to 10)
VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.
No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever.
Measured: 1 week
Pain(at 1 Week): Nirschl Staging (0 to 7)
NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Measured: 1 week
Pain(at 4 Weeks): Visual Analogue Scale
VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Measured: 4 weeks
Pain(at 4 Weeks): Nirschl Staging
NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Measured: 4 weeks
Pain(at 12 Weeks): Visual Analogue Scale
VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Measured: 12 weeks
Pain(at 12 Weeks): Nirschl Staging
NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Measured: 12 weeks
Pain(at 6 Months): Visual Analogue Scale
VISUAL ANALOGUE SCALE:
Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.
No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Measured: 6 months
Pain(at 6 Months): Nirschl Staging
NIRSCHL STAGING:
phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps
No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dojode, Chetan M., MBBS, MS
- Investigators
- Dr. Vijay kumar G Murakibhavi, MS(Ortho), Study chair, Professor of Orthopaedics. Jawaharlal Nehru Medical College. Belgaum. Karnataka. India.Dr. Chetan M Dojode, MBBS,MS(Ortho), Study chair, Senior Resident (Dept. of Orthopaedic and Traumatology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947765
- Sponsor's protocol ID
- Lateralepicondylitis- ChetanMD
- Status last verified
- Oct 2009
- First submitted
- 27 Jul 2009
- Last updated
- 28 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Edwards SG, Calandruccio JH. Autologous blood injections for refractory lateral epicondylitis. J Hand Surg Am. 2003 Mar;28(2):272-8. doi: 10.1053/jhsu.2003.50041.
PubMed 12671860
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT00947765
- Acronym / sponsor ID
- Lateralepicondylitis- ChetanMD
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Keywords
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dojode, Chetan M., MBBS, MS
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 23 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral epicondylitis, is a common problem encountered in the orthopaedic practice. Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. Beneficial effects of local corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens show lack of any inflammatory process. Recently an injection of "autologous blood injection" has been reported to be effective for both intermediate and long term outcomes. It is hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to induce healing cascade. The objective of the study is to evaluate the efficacy of autologous blood injection versus local corticosteroid injection in the management of lateral epicondylitis.
Detailed description
Much controversy has been there over the pathophysiology and there is not enough scientific evidence to favour any particular type of treatment for acute lateral epicondylitis. Currently degeneration of the origin of the extensor carpi radialis brevis (ECRB), repeated micro trauma and incomplete healing response has been accepted as the cause of lateral epicondylitis by most of the researchers.
Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. There are numerous treatment modalities for lateral epicondylitis both conservative and operative. Most conservative modalities such as local corticosteroid injection have focused on suppressing inflammatory process that does not actually exist. A recent review article concluded that for short term outcomes (6 weeks), statistically significant and clinically relevant differences were found on pain and global improvement with corticosteroid injection compared to placebo, local anaesthetic, or other conservative treatments. For intermediate (6 weeks to 6 months) and long term outcomes (more than 6 months), no statistically significant or clinically relevant results in favour of corticosteroid injections were found. So it is not possible to draw a firm conclusion on the effectiveness of corticosteroid injection.
Recently an injection of autologous blood has been reported to be effective for both intermediate and long term outcomes for the treatment of lateral epicondylitis. There was a significant decrease in pain. It is hypothesized that mitogens such as platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to cause angiogenesis. A specific humoral mediator may promote the healing cascade in the treatment of tendinosis as well. These growth factors trigger stem cell recruitment, increase local vascularity and directly stimulate the production of collagen by tendon sheath fibroblasts.
Autologous blood was selected as the medium for injection because (1) its application is minimally traumatic, (2) it has a reduced risk for immune-mediated rejection, devoid of potential complications such as hypoglycemia, skin atrophy, tendon tears associated with corticosteroid injection (3) it is simple to acquire and prepare, easy to carry out as outpatient procedure and (4) it is inexpensive.
There are very few studies done to evaluate injection of autologous blood for lateral epicondylitis as treatment modality. Hence it is evaluated by comparing with the corticosteroid injection which is a commonly practiced conservative treatment modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous blood injection group | Experimental | Biological: Autologous blood injectionThis is the study group in whom autologous blood injection was injected at lateral epicondylitis site. |
| Local corticosteroid injection group | Active comparator | Drug: Local corticosteroid injectionThis is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cases of lateral epicondylitis.
- Men and women above fifteen years of age.
Key exclusion criteria (4 listed)
- Patients receiving steroid injections within three months before blood injection.
- A history of substantial trauma.
- Previously treated by surgery for lateral epicondylitis.
- Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.
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 |
|---|---|---|
| Autologous blood injectionAlso: autologous blood drawn from peripheral vein.Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique. | Biological | Autologous blood injection group |
| Local corticosteroid injectionAlso: Methyl prednisolone acetate 80mgPatients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique | Drug | Local corticosteroid injection group |
Primary outcome
Pain (at 1 Week): Visual Analogue Scale(0 to 10)
Time frame: 1 week
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever.
Pain(at 1 Week): Nirschl Staging (0 to 7)
Time frame: 1 week
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain(at 4 Weeks): Visual Analogue Scale
Time frame: 4 weeks
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 4 Weeks): Nirschl Staging
Time frame: 4 weeks
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain(at 12 Weeks): Visual Analogue Scale
Time frame: 12 weeks
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 12 Weeks): Nirschl Staging
Time frame: 12 weeks
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Pain(at 6 Months): Visual Analogue Scale
Time frame: 6 months
VISUAL ANALOGUE SCALE: Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark. No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.
Pain(at 6 Months): Nirschl Staging
Time frame: 6 months
NIRSCHL STAGING: phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12671860Edwards SG, Calandruccio JH. Autologous blood injections for refractory lateral epicondylitis. J Hand Surg Am. 2003 Mar;28(2):272-8. doi: 10.1053/jhsu.2003.50041.
- Sonographic-guided blood injection has been reported to improve clinical outcome. It can also be used to monitor the changes to the common extensor originLink provided by the sponsor.
- Autologous preparations rich in growth factors promote proliferation and induce VEGF and HGF production by human tendon cells in culture.Link provided by the sponsor.
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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.
Dr. Vijay kumar G Murakibhavi, MS(Ortho) study chair
Professor of Orthopaedics. Jawaharlal Nehru Medical College. Belgaum. Karnataka. India.
Dr. Chetan M Dojode, MBBS,MS(Ortho) study chair
Senior Resident (Dept. of Orthopaedic and Traumatology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous blood injection and Local corticosteroid injection in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Dojode, Chetan M., MBBS, MS at 1 site in India.
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 2 inclusion and 4 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 28 Jul 2010. 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 India. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain (at 1 Week): Visual Analogue Scale(0 to 10) (time frame: 1 week). The study lists 8 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 NCT00947765, which also lists 1 linked publication.
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 28 Jul 2010.