2. Mohsen Mardani-Kivi, M.D.
A randomized prospective comparative study of four methods of treatment: US, LLL/US, intra-sheath and extra-sheath corticosteroid US guided injection
Mohsen Mardani-Kivi, M.D.
Associate Professor
Guilan University Of Medical Sciences

3. Ghaem hospital, Rasht, Iran
Poursina hospital, Rasht, Iran 3 3

4. Author’s Disclosure
There was no conflicts of interest or financial ties to be disclosed.

5. Background Best treatment method? US LLL+US Guided CSI
Intasheath vs. Extrasheath (Does it really matter?)
Considerable controversy exists about long head of the biceps (LHB) tendon roles and functions. Similar to other inflammatory tendinopathies, treatment of LHB tendinopathy includes conservation and surgical approaches. The most widely used physiotherapeutic methods for treatment of tendinopathies are low level laser treatment (LLLT) and ultrasound (US). Peri-tendon corticosteroid injections are used in many tendinopathies. Contrary to the wide use of local injection of corticosteroids, disagreement exists about their effectiveness in treatment of LHB tendonitis.

6. The purpose of the study
to compare the therapeutic effects between four methods of US alone or in combination with LLLT (L/US), intra and extra sheath US guided injection in treatment of LHB tendonitis.
the aim of the present study was to compare the therapeutic effects between four methods of US alone or in combination with LLLT (L/US), intra and extra sheath US guided injection in treatment of LHB tendonitis.

7. 4-groups parallel RCT
Inclusion criteria: 22-60y years, pain continued more than 3 months, local tenderness in bicipital groove, at least one biceps positive test.
Exclusion criteria: history of trauma, injection or surgery in affected shoulder, calcification in rotator cuff, and any signs of partial or complete dislocations or raptures of LHB
patients with confirmed LHB tendonitis were enrolled in a 4-groups parallel randomized clinical trial (RCT). Our inclusion criteria were pain history of shoulder or forelimb that continued more than 3 months, local tenderness in bicipital groove, at least one biceps positive test (Yergason`s test or Speed test), and lack of any evidence about complete or incomplete rupture of rotator cuff.

8. US: 10 sessions of US with frequency of 1MHz and intensity of 1 W/cm2 by pulse mode duty cycle of 2:8 and probe surface of 5 cm2 were applied for 5 min in each session
In US group 10 sessions of US with these characteristics were applied for 5 min in each session.

9. LLT+US: infrared laser with pencil probe gallium arsenide aluminum (830 nm wave length, 30 mW power, 1 J/cm2 intensity, 4 mm ray diameter, and 2.5° angle of divergence)
In L/US program the type and frequency of US were similar to the previous group. In addition, LLLT was performed using infrared laser with pencil probe gallium arsenide aluminum.

10. InCI: linear probe, 2-20, 1ml of 40 mg/ml methyl prednisolone acetate solution and 1 ml of 2% lidocaine solution
In InCI group With the help of the linear probe LHB tendon was found in bicipital groove. One ml of 40 mg/ml methyl prednisolone acetate solution and 1 ml of 2% lidocaine solution were mixed together and injected intra tendon sheath under US guide.

11. ExCI: similar to InCI, solution was injected extra tendon sheath.
In ExCI group all steps and equipment were similar to previous group with the difference being that solution was injected extra tendon sheath.

12. Follow UP 5 times F/U in 1 year
Primary outcome: Pain intensity => VAS
Secondary outcome: Shoulder function => CMS
Patient’s evaluations were performed by an orthopedist who was blinded to treatment method 5 times: before intervention, 1 week, 1 and 3 months and 1 year after treatment. The primary outcome pain intensity was evaluated at all five visits using Visual Analogue Scale (VAS). Secondary outcome was CMS.

13. Totally, 204 patients were included and at the end of one year the follow-up of 142 cases was done

14. Results Baseline assessment
No significant differences existed in demographic information between four groups. No statistically significant differences were detected in pain intensity based on VAS score (P=0.076) and shoulder function based on CMS score (P=0.076) before treatment between 4 groups.

15. Results
VAS and CMS scores were improved after treatment in all 4 groups and in all visits in comparison to before treatment.

16. Results
1- VAS and CMS scores were improved after treatment in all 4 groups and in all visits in comparison to before treatment.
2- The GREATEST decline in VAS score and HIGHEST increase in CMS score were seen in InCI group.
3- VAS score of InCI group in ONE WEEK visit was lower than all other groups
1- VAS and CMS scores were improved after treatment in all 4 groups and in all visits in comparison to before treatment
2- The greatest decline in VAS score and highest increase in CMS score were seen in InCI group.
3- VAS score of InCI group in 2nd visit was lower than all other groups.

17. Results
4- VAS score were similar between two injection groups from 1 month to 1 year F/U.
5- Shoulder function based on CMS was similar in all visits between both injection groups
6- in the 1 week to 6 months visits, significant differences were seen between injection groups and two other non-injection groups.
7- In 1 year visit CMS differences between injection and L/US groups were not significant but were significant in comparison to US group.

18. Present study: One week after treatment, pain intensity in the InCI group was significantly lower than the other 3 groups. However, after 3 weeks this difference between this group and ExCI disappeared.
Zhang etal.: higher accuracy of injection under US guidance could be the cause of better results in guided group in comparison to blinded group
Our main issue in this study was to determine whether intra or extra tendon sheath injections affect the results or not. One week after treatment, pain intensity in the InCI group was significantly lower than the other 3 groups. However, after 3 weeks this difference between this group and ExCI disappeared. The range of change is comparable with InCI in the study of Zhang and colleagues. They concluded that higher accuracy of injection under US guidance could be the cause of better results in guided group in comparison to blinded group
Zhang J, etal. Ultrasound in medicine & biology 2011;37(5):729-33

19. Hashiuchi et al.: Injection under US guidance had higher accuracy against blinded injection.
It seems that intra tendon sheath corticosteroid injection has no advantages against extra tendon sheath injection with regard to shoulder function
Hashiuchi et al. showed that injection under US guidance had higher accuracy against blinded injection. Lack of accuracy in blinded injection causes extra- or combination of extra and intra tendon sheath injections. The most important reason for use of US guidance in treatment of LHB tendonitis is to confirm intra-sheath delivery. But, based on the findings of this study, it seems that intra tendon sheath corticosteroid injection has no advantages against extra tendon sheath injection with regard to shoulder function. Although more dramatic pain reduction is seen in a short time the results quickly become similar to extra sheath injection.
Hashiuchi T etal. Journal of shoulder and elbow 2011;20(7):

20. Otadi et al. : Better further effectiveness of L/US against US.
LLLT+US produce better and more rapid results than US alone. When the therapist does not have enough expertise in local injection, it is better to use L/US and not US alone in treatment of LHB tendonitis.
In Otadi et al’s study, addition of LLLT to US could enhance the effects of US alone. Otadi et al. study, similar to our study, confirms the better further effectiveness of L/US against US. Also, other studies reported that use of US alone was not effective. Debates about the effectiveness of these methods are still ongoing but the result of our study showed that concurrent use of LLLT and US produce better and more rapid results than US alone.
Otadi K etal. Journal of back and musculoskeletal rehabilitation. 2012;25(1):13-9.

21. Discussion DM has no effects on the treatment trend of LHB tendonitis.
Intensity of activity has no effect on trend of improvement

22. Limitations 1- low number of DM and non-DM patients
2- lack of complete blindness of patients.
3- Concurrent existence of inflammatory diseases of shoulder joint (arthritis or capsulitis)
4- Possibility of using other drugs or traditional medicinal agents as arbitrary and secret.

23. Take home message
Although US guided InCI is an effective method for LHB tendonitis especially in the first week, but ExCI also has acceptable results.

24. Take home message
Using L/US as a less invasive treatment could be as effective as corticosteroid injection in the long term.
We do not recommend US alone

25. Thank you for your attention