Trial Outcomes & Findings for A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis (NCT NCT00947765)

NCT ID: NCT00947765

Last Updated: 2010-07-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2010-07-28

Participant Flow

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.

Participant milestones

Measure	Autologous Blood Injection Group This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis

Baseline characteristics by cohort

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	42.9 years STANDARD_DEVIATION 12.7721 • n=5 Participants	42.3 years STANDARD_DEVIATION 9.51 • n=7 Participants	42.6 years STANDARD_DEVIATION 11.1678 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment India	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Laterality of limb involved Participants with Right limb involved	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Laterality of limb involved Participants with Left limb involved	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Participants with Dominant and Non-Dominent limb involvement Participants with Dominent limb involved	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants
Participants with Dominant and Non-Dominent limb involvement Participants with Non-Dominant limb involved	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Pain: Nirschl Staging (0 to 7)	5.4 Units on a scale STANDARD_DEVIATION 1.1325 • n=5 Participants	5.23 Units on a scale STANDARD_DEVIATION 0.9714 • n=7 Participants	5.315 Units on a scale STANDARD_DEVIATION 1.049 • n=5 Participants
Pain: Visual Analogue Scale (0 to 10)	7.7 Units on a scale STANDARD_DEVIATION 1.3429 • n=5 Participants	7.533 Units on a scale STANDARD_DEVIATION 1.2794 • n=7 Participants	7.616 Units on a scale STANDARD_DEVIATION 1.303 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Participants were clinically examined for the treatment response i.e., decrease in pain.

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.

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain (at 1 Week): Visual Analogue Scale(0 to 10)	7.166 Units on a scale Standard Deviation 1.9312	4.5 Units on a scale Standard Deviation 1.8708

PRIMARY outcome

Timeframe: 1 week

Population: Participants were clinically examined for the treatment response i.e., decrease in pain.

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

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 1 Week): Nirschl Staging (0 to 7)	5.1 Units on a scale Standard Deviation 1.4703	3.06 Units on a scale Standard Deviation 1.3629

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 4 Weeks): Visual Analogue Scale	3.2 Units on a scale Standard Deviation 2.369	1.533 Units on a scale Standard Deviation 2.315

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 4 Weeks): Nirschl Staging	2.2 Units on a scale Standard Deviation 1.6484	1.03 Units on a scale Standard Deviation 1.5862

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 12 Weeks): Visual Analogue Scale	0.6 Units on a scale Standard Deviation 1.9046	1.5 Units on a scale Standard Deviation 1.8147

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 12 Weeks): Nirschl Staging	0.433 Units on a scale Standard Deviation 1.278	1.03 Units on a scale Standard Deviation 1.3257

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 6 Months): Visual Analogue Scale	0.533 Units on a scale Standard Deviation 1.907	1.833 Units on a scale Standard Deviation 2.0356

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Autologous Blood Injection Group n=30 Participants This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 Participants This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Pain(at 6 Months): Nirschl Staging	0.366 Units on a scale Standard Deviation 1.2726	1.233 Units on a scale Standard Deviation 1.4308

Adverse Events

Autologous Blood Injection Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local Corticosteroid Injection Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Autologous Blood Injection Group n=30 participants at risk This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 participants at risk This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Musculoskeletal and connective tissue disorders Elbow stiffness	0.00% 0/30 • Follow up was done up to 6 months.	0.00% 0/30 • Follow up was done up to 6 months.
Skin and subcutaneous tissue disorders Infection	0.00% 0/30 • Follow up was done up to 6 months.	0.00% 0/30 • Follow up was done up to 6 months.
Nervous system disorders Injury to cutanous nerve	0.00% 0/30 • Follow up was done up to 6 months.	0.00% 0/30 • Follow up was done up to 6 months.
Skin and subcutaneous tissue disorders Local skin atrophy	0.00% 0/30 • Follow up was done up to 6 months.	6.7% 2/30 • Number of events 2 • Follow up was done up to 6 months.

Other adverse events

Measure	Autologous Blood Injection Group n=30 participants at risk This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Local Corticosteroid Injection Group n=30 participants at risk This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Endocrine disorders Systemic affects of Corticosteroid injection	— 0/0 • Follow up was done up to 6 months.	0.00% 0/30 • Follow up was done up to 6 months.

Additional Information

Dr. Chetan Muralidhara Rao Dojode, MBBS,MS(Ortho)

Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.

Phone: 91 9844592532

Email: docchetanmd@yahoo.co.in

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place