Amnion-Based Injections in the Shoulder
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | June 2019 |
| End Date: | January 2021 |
| Contact: | Brent A Ponce, MD |
| Email: | bponce@uabmc.edu |
| Phone: | (205) 975-2310 |
Amnion-Based Injections in the Shoulder for Adhesive Capsulitis and Osteoarthritis
Osteoarthritis (OA) of the shoulder is a common debilitating condition affecting up to 5% of
the general population and as much as 32% of patients over 60 years of age. Clinically, OA is
diagnosed by a combination of symptoms, such as slow onset of progressively worsening
shoulder pain and stiffness over months to years (often with a history of minor trauma), and
pain with activity. Physical exam may show tenderness and swelling, muscle atrophy, and
decreased range of motion. Adhesive capsulitis (also called "Frozen Shoulder") is another
common shoulder condition, affecting 2-5% of the general population. Frozen shoulder presents
with a similar combination of symptoms, such as inability to sleep on the side of the
affected shoulder, shoulder pain, and pain at extremes of active and passive range of motion.
Despite the ubiquitous nature of these conditions, various non-operative treatment modalities
have been employed in their managements without a clearly superior alternative. The usual
initial treatment strategy for both of these conditions is the same: a trial of conservative
management. Conservative management includes physical therapy, supervised neglect,
over-the-counter pain medications (including NSAIDs, like Advil), oral and intra-articular
corticosteroid use (steroids), hydrodilatation (capsular distension to rupture),
intra-articular hyaluronic acid injections. Despite several years of employing different
modes of treatment, there is no evidence that places one treatment modality over the others,
and patients will often need surgery.
Amniotic fluid's apparent ability to improve blood flow, re-organize collagen, and protect
cartilage makes it theoretically ideal for disorders like osteoarthritis and frozen shoulder.
In recent studies, it has shown efficacy in promoting ligament healing in the knee and
promoting tendon and degenerative joint pain reduction and functional improvement. It has
been useful as a material for cartilage repair when used as a scaffold. Intra-articular
amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the
shoulder or frozen shoulder. To test this hypothesis, intra-articular amnion will be injected
into the shoulders of 20 patients with moderate to severe osteoarthritis and 20 patients with
frozen shoulder. The hypothesis is that improvement in short-term outcomes (pain, function,
and range of motion) will be identified following amnion injection in these patients. The
goal of this study is to lead to larger randomized controlled trials evaluating amnion
against current forms of treatment for osteoarthritis.
the general population and as much as 32% of patients over 60 years of age. Clinically, OA is
diagnosed by a combination of symptoms, such as slow onset of progressively worsening
shoulder pain and stiffness over months to years (often with a history of minor trauma), and
pain with activity. Physical exam may show tenderness and swelling, muscle atrophy, and
decreased range of motion. Adhesive capsulitis (also called "Frozen Shoulder") is another
common shoulder condition, affecting 2-5% of the general population. Frozen shoulder presents
with a similar combination of symptoms, such as inability to sleep on the side of the
affected shoulder, shoulder pain, and pain at extremes of active and passive range of motion.
Despite the ubiquitous nature of these conditions, various non-operative treatment modalities
have been employed in their managements without a clearly superior alternative. The usual
initial treatment strategy for both of these conditions is the same: a trial of conservative
management. Conservative management includes physical therapy, supervised neglect,
over-the-counter pain medications (including NSAIDs, like Advil), oral and intra-articular
corticosteroid use (steroids), hydrodilatation (capsular distension to rupture),
intra-articular hyaluronic acid injections. Despite several years of employing different
modes of treatment, there is no evidence that places one treatment modality over the others,
and patients will often need surgery.
Amniotic fluid's apparent ability to improve blood flow, re-organize collagen, and protect
cartilage makes it theoretically ideal for disorders like osteoarthritis and frozen shoulder.
In recent studies, it has shown efficacy in promoting ligament healing in the knee and
promoting tendon and degenerative joint pain reduction and functional improvement. It has
been useful as a material for cartilage repair when used as a scaffold. Intra-articular
amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the
shoulder or frozen shoulder. To test this hypothesis, intra-articular amnion will be injected
into the shoulders of 20 patients with moderate to severe osteoarthritis and 20 patients with
frozen shoulder. The hypothesis is that improvement in short-term outcomes (pain, function,
and range of motion) will be identified following amnion injection in these patients. The
goal of this study is to lead to larger randomized controlled trials evaluating amnion
against current forms of treatment for osteoarthritis.
Amnion injections are commonly performed by community orthopaedic surgeons for many
conditions, including osteoarthritis, rotator cuff tears, tendinitis, and others. Human
placental tissue has been reported to contain biochemical and immunologic properties that
play key roles in regulation of the inflammation-healing cycle. Amnion-chorion membrane has
been shown to contain high concentrations of collagens, transforming growth factor beta
suppressors, and inhibitors of matrix metalloproteinases that provide strong scaffolding,
suppress scar formation, and regulate tissue remodeling, respectively. The amnion injection
is a morselized, flowable tissue allograft derived from human amniotic tissues. The amniotic
tissue comes from placenta, donated by pre-screened healthy women undergoing scheduled
C-sections. It is processed into a form that can be injected.
Similarly, in a recent study injection of micronized dehydrated human amnion-chorion membrane
slowed the development of cartilaginous lesions and led to a decreased number of erosions in
a rat model of osteoarthritis. There is also an emerging body of literature investigating its
use in osteoarthritis of the knee, with promising early results. In one study human amniotic
suspension allograft was injected into patients with symptomatic knee osteoarthritis. No
significant reactions were noted and the feasibility of injection for treatment of the
osteoarthritis in the knee was demonstrated. Another study found that human amniotic fluid
had a positive effect on tibia fracture healing through a rat model. In an osteoarthritis
model, injection demonstrated attenuation of cartilage destruction and significant increases
in cartilage thickness and volume. Finally, patients with plantar fasciitis noted significant
improvement in symptoms, and American Orthopaedic Foot and Ankle Society Hindfoot scores
(pain, function, alignment) compared to controls. These studies suggest the safety and
efficacy of amnion-based injections in treating specific orthopaedic pathologies.
Osteoarthritis and adhesive capsulitis are two common pathologies of the shoulder. There is a
variety of options for conservative management including physical therapy, pain medications,
and injections, but no evidence that places one modality over another. The purpose of this
study is the evaluate the effectiveness of amniotic fluid injection in treating these
pathologies. In this study intra-articular amnion will be injected into the shoulders of
patients with moderate to severe osteoarthritis and patients with frozen shoulder and
assessing pain, function and range of motion over time.
conditions, including osteoarthritis, rotator cuff tears, tendinitis, and others. Human
placental tissue has been reported to contain biochemical and immunologic properties that
play key roles in regulation of the inflammation-healing cycle. Amnion-chorion membrane has
been shown to contain high concentrations of collagens, transforming growth factor beta
suppressors, and inhibitors of matrix metalloproteinases that provide strong scaffolding,
suppress scar formation, and regulate tissue remodeling, respectively. The amnion injection
is a morselized, flowable tissue allograft derived from human amniotic tissues. The amniotic
tissue comes from placenta, donated by pre-screened healthy women undergoing scheduled
C-sections. It is processed into a form that can be injected.
Similarly, in a recent study injection of micronized dehydrated human amnion-chorion membrane
slowed the development of cartilaginous lesions and led to a decreased number of erosions in
a rat model of osteoarthritis. There is also an emerging body of literature investigating its
use in osteoarthritis of the knee, with promising early results. In one study human amniotic
suspension allograft was injected into patients with symptomatic knee osteoarthritis. No
significant reactions were noted and the feasibility of injection for treatment of the
osteoarthritis in the knee was demonstrated. Another study found that human amniotic fluid
had a positive effect on tibia fracture healing through a rat model. In an osteoarthritis
model, injection demonstrated attenuation of cartilage destruction and significant increases
in cartilage thickness and volume. Finally, patients with plantar fasciitis noted significant
improvement in symptoms, and American Orthopaedic Foot and Ankle Society Hindfoot scores
(pain, function, alignment) compared to controls. These studies suggest the safety and
efficacy of amnion-based injections in treating specific orthopaedic pathologies.
Osteoarthritis and adhesive capsulitis are two common pathologies of the shoulder. There is a
variety of options for conservative management including physical therapy, pain medications,
and injections, but no evidence that places one modality over another. The purpose of this
study is the evaluate the effectiveness of amniotic fluid injection in treating these
pathologies. In this study intra-articular amnion will be injected into the shoulders of
patients with moderate to severe osteoarthritis and patients with frozen shoulder and
assessing pain, function and range of motion over time.
Inclusion Criteria:
- Age 18 years or greater
- Clinical diagnosis of adhesive capsulitis, clinically in the frozen phase at the time
of enrollment OR Clinical diagnosis of osteoarthritis of the shoulder.
- Symptoms for 2-6 months
- Failure of conservative management.
- > 25% reduction in active range of motion in >= 2/3 planes of motion in the affected
shoulder.
- No alternative medical explanation for symptoms
Exclusion Criteria:
- Alternative explanation for symptoms including neurological disorders, or like
conditions
- Pregnancy or desire to become pregnant
- Discretion of the enrolling clinician
Exclusion in Amnion Injection Group:
• Intra-articular steroid injection within 6 months of enrollment or surgical intervention
in the within 12 months of enrollment in affected shoulder
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