Epicondylitis, Lateral Humeral, Tennis Elbow
Conditions
Keywords
Tennis Elbow, Epicondylitis, Lateral Humeral
Brief 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'. 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.
Interventions
BIOLOGICALAutologous blood injection
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.
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
Sponsors
Dojode, Chetan M., MBBS, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Cases of lateral epicondylitis. 2. Men and women above fifteen years of age.
Exclusion criteria
1. Patients receiving steroid injections within three months before blood injection. 2. A history of substantial trauma. 3. Previously treated by surgery for lateral epicondylitis. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (at 1 Week): Visual Analogue Scale(0 to 10) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Countries
India
Participant flow
Recruitment details
Participants were selected by interview and clinical examination and Consent was taken. Location: Out patient department of KLES Dr. Prabhakar Kore Hospital & MRC, Belgaum. Period: January 1st, 2007-December 31st, 2007. No blinding procedure was followed. Randomization: participants were assigned into two groups according to randomization table.
Participants by arm
| Arm | Count |
|---|---|
| Autologous Blood Injection Group This is the study group in whom autologous blood injection was injected at lateral epicondylitis site. | 30 |
| Local Corticosteroid Injection Group This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Autologous Blood Injection Group | Local Corticosteroid Injection Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 29 Participants | 57 Participants |
| Age Continuous | 42.9 years STANDARD_DEVIATION 12.7721 | 42.3 years STANDARD_DEVIATION 9.51 | 42.6 years STANDARD_DEVIATION 11.1678 |
| Laterality of limb involved Participants with Left limb involved | 7 participants | 7 participants | 14 participants |
| Laterality of limb involved Participants with Right limb involved | 23 participants | 23 participants | 46 participants |
| Pain: Nirschl Staging (0 to 7) | 5.4 Units on a scale STANDARD_DEVIATION 1.1325 | 5.23 Units on a scale STANDARD_DEVIATION 0.9714 | 5.315 Units on a scale STANDARD_DEVIATION 1.049 |
| Pain: Visual Analogue Scale (0 to 10) | 7.7 Units on a scale STANDARD_DEVIATION 1.3429 | 7.533 Units on a scale STANDARD_DEVIATION 1.2794 | 7.616 Units on a scale STANDARD_DEVIATION 1.303 |
| Participants with Dominant and Non-Dominent limb involvement Participants with Dominent limb involved | 25 participants | 26 participants | 51 participants |
| Participants with Dominant and Non-Dominent limb involvement Participants with Non-Dominant limb involved | 5 participants | 4 participants | 9 participants |
| Region of Enrollment India | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 2 / 30 |
Outcome results
Primary
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 12 Weeks): Nirschl Staging | 0.433 Units on a scale | Standard Deviation 1.278 |
| Local Corticosteroid Injection Group | Pain(at 12 Weeks): Nirschl Staging | 1.03 Units on a scale | Standard Deviation 1.3257 |
p-value: 0.0184Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 12 Weeks): Visual Analogue Scale | 0.6 Units on a scale | Standard Deviation 1.9046 |
| Local Corticosteroid Injection Group | Pain(at 12 Weeks): Visual Analogue Scale | 1.5 Units on a scale | Standard Deviation 1.8147 |
p-value: 0.0127Wilcoxon (Mann-Whitney)
Primary
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
Time frame: 1 week
Population: Participants were clinically examined for the treatment response i.e., decrease in pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 1 Week): Nirschl Staging (0 to 7) | 5.1 Units on a scale | Standard Deviation 1.4703 |
| Local Corticosteroid Injection Group | Pain(at 1 Week): Nirschl Staging (0 to 7) | 3.06 Units on a scale | Standard Deviation 1.3629 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 1 week
Population: Participants were clinically examined for the treatment response i.e., decrease in pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain (at 1 Week): Visual Analogue Scale(0 to 10) | 7.166 Units on a scale | Standard Deviation 1.9312 |
| Local Corticosteroid Injection Group | Pain (at 1 Week): Visual Analogue Scale(0 to 10) | 4.5 Units on a scale | Standard Deviation 1.8708 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 4 Weeks): Nirschl Staging | 2.2 Units on a scale | Standard Deviation 1.6484 |
| Local Corticosteroid Injection Group | Pain(at 4 Weeks): Nirschl Staging | 1.03 Units on a scale | Standard Deviation 1.5862 |
p-value: 0.003Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 4 Weeks): Visual Analogue Scale | 3.2 Units on a scale | Standard Deviation 2.369 |
| Local Corticosteroid Injection Group | Pain(at 4 Weeks): Visual Analogue Scale | 1.533 Units on a scale | Standard Deviation 2.315 |
p-value: 0.0022Wilcoxon (Mann-Whitney)
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 6 Months): Nirschl Staging | 0.366 Units on a scale | Standard Deviation 1.2726 |
| Local Corticosteroid Injection Group | Pain(at 6 Months): Nirschl Staging | 1.233 Units on a scale | Standard Deviation 1.4308 |
p-value: 0.0064Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Autologous Blood Injection Group | Pain(at 6 Months): Visual Analogue Scale | 0.533 Units on a scale | Standard Deviation 1.907 |
| Local Corticosteroid Injection Group | Pain(at 6 Months): Visual Analogue Scale | 1.833 Units on a scale | Standard Deviation 2.0356 |
p-value: 0.0058Wilcoxon (Mann-Whitney)