Use of localized human growth hormone/testosterone injections for - - PowerPoint PPT Presentation

Use of localized human growth hormone/testosterone injections for chronic shoulder pain: a single group pretest-posttest design, with 12 month follow-up IRB sanctioned study

, Marc N. Dubick, M.D.

Anesthesiology Interventional Pain Management Charleston, South Carolina

Objective

• Investigate the feasibility and safety of a

new injection technique for the treatment

• f chronic shoulder pain.
• Localized hGH/testosterone injections at

capsular ligaments and labrum in individuals who presented with chronic shoulder pain with a proposed diagnosis of capsular pain and/or laxity.

Outcome

• Measured at 12 months following

injections

Setting

• Community based hospital affiliated
• ffice and a private block suite

Positive Findings Physical Examination Obrien’s Active Compression Test Seated Apprehension Test Internal/External Rotation Rotator cuff testing

Areas Treated

Inferior, middle, superior glenohumeral ligaments on both glenoid and humeral sides Long head of the bicep tendon attachment at superior aspect of the glenoid Rotator cuff attachments on humerus when indicated

Patient numbers

• 23 consecutive patient shoulders met

inclusion criteria

• 19 provided informed consent
• 16 completed all aspects of the study

Figure 2. Shoulder Pain and Disability Index (SPADI) scores pre- and post-test.

Figure 2. Shown above are the point estimates for the mean scores and 95% confidence

limits for the SPADI scores, which shows a mean reduction of 31.8 points (95% CI: 20.7- 43.0, p<.0001). The minimal detectable change is 18.1 points, with a minimal clinically- important difference of 13.2 points (Schmitt & Di Fabio, 2004).

31pts

Figure 3. Shoulder Pain Scores (SPS) scores pre- and post-test. Figure 3. The point estimates for the mean scores and 95% confidence limits for the SPS scores, which shows a mean reduction of 36.7 points (95% CI: 24.0-49.4, p<.0001).

37pts

Figure 4. Mankowski Pain Scale Index (MPSI) scores pre- and post- test. Figure 4. The point estimates for the mean scores and 95% confidence limits for the MPSI scores, which shows a mean reduction of 3.1 points (95% CI: 2.0-4.2, p<.0001).

3.1 pts

Significant improvement in the participants’ report of symptom decrease

• f 76%

Patients Who Withdrew

• Two underwent surgery prior to the 12

month time frame

• One switched to another interventional

therapy prior to the 12 month follow-up

• One lost to follow-up

Conclusion

• Safe
• Reasonable expectation that treatment

is beneficial for those who met diagnostic criteria

• Further study of the procedure may be

warranted

hGH

• Protein hormone
• Strongest anabolic hormone in the body
• Stimulates tissue growth, cell reproduction,

regeneration, protein synthesis

• Increases wound collagen content and

wound tensile strength

• Bonds to hGH receptor site on target cells
• Is an activating factor for macrophages

Testosterone

• Steroid hormone
• Strong androgenic and moderate anabolic

actions

• Levels decrease with chronic injury, pain, and

stress

• Decrease levels impair wound healing
• Bonds to androgenic receptor site on target

cells

Initiating Wound Healing

• Create acute injury by needling each treatment

area at the enthesis, causing micro bleeding.

• All blood components are present, including the

resident macrophages which are felt to control wound healing through the production of growth factors and attracting stem cells to the site.

• Vital interactions take place in wound healing

simultaneously among hGH, Testosterone, IGF-1, Growth Factors, Macrophages, Fibroblasts, Platelets, Stem Cells

Injection Medication per 10 cc

• Omnitrope (Sandoz) recombinant human

growth hormone 3u/10 cc volume

• Testosterone aqueous 12.5 mg woman, 25 mg

men per 10cc volume

• Lidocaine 1% PF 4cc
• NaCl PF to 10cc
• Number of procedures average 3 spaced 3-4

weeks apart

Recovery Time Not a quick fix Wound healing takes place over a 3- 6 month period Takes time for newly formed connective

tissue to mature into functional ligament tissue

Orthobiologics and Regenerative Medicine Revolution

Autologous Blood Bone Marrow Concentrate Cartilage Regeneration Hgh/testosterone PRP Stem Cells