Shoulder PainEarly Phase 1NCT03167138
Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
A Early Phase 1 study testing Autologous micro-fragmented adipose tissue and Lipogems system in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Kessler Foundation at 1 site in United States.
Trial summary
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome
- What is being tested?
- Autologous micro-fragmented adipose tissue and Lipogems system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 21 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is male or female, 18 to 60 years of age, inclusive.
- The subject has neurological impairment secondary to a spinal cord injury that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C5 and L5, inclusive.
- The subject is non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (> 40 hours/week).
- The subject currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment (Note: rotator cuff disease will be defined as pain over the anterior shoulder, with direct palpation and pain at the shoulder with provocative tests for rotator cuff disease that is confirmed by tendinopathic changes on ultrasound imaging).
- The average shoulder pain intensity during the week leading up to the Screening Visit should be at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
- The subject is able and willing to comply with the protocol.
- The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Who cannot join
- The subject reports prior Lipogems treatment in the same shoulder.
- The subject reports a history of systemic disorders, such as diabetes or rheumatoid arthritis.
- The subject has contra-indications to the procedure, such as infection, coagulopathy, or is currently taking anti-coagulants.
- The subject reports having a glucocorticoid injection in the past 4 weeks.
- The subject is pregnant (documented by a urine pregnancy test).
- The subject has any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results or the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.
Read the detailed description
This is an exploratory pilot study to determine the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic, nonresponsive shoulder pain due to rotator cuff disease (i.e., rotator cuff tendinopathy) in persons with spinal cord injury (SCI). Twelve (12) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment who are diagnosed with rotator cuff disease on examination. Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. The final product will consist of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. Approximately 6 mL of micro-fragmented adipose will be injected into the tendon with a 22-gauge needle under continuous ultrasound guidance. No other biological or pharmacological agents will be used in combination with the micro-fragmented adipose. After 24 hours, subjects will be given a standardized stretching protocol to follow for 4 weeks followed by a formal strengthening program. Participants will be followed for adverse events and changes in shoulder pain intensity on an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine"); the Wheelchair User's Shoulder Pain Index (WUSPI; 15-item disease-specific functional measure of shoulder pain in persons with SCI); the Brief Pain Inventory interference items (BPI-I7; a subscale of 7 items measuring interference with general activity, sleep, mood, relationships, etc.); and a 5-point subject global impression of change (SGIC) scale. Subjects will be examined at 1 month, 2 months, 3 months, and 6 months after the treatment. Follow-up shoulder ultrasound will be performed at 6 months.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Spinal Cord Injuries
- Being tested
- Autologous micro-fragmented adipose tissue, Lipogems system
- Keywords
- Shoulder pain, Rotator cuff disease, Spinal cord injuries, Mesenchymal stromal cells, Regenerative medicine, Rehabilitation
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous micro-fragmented adipose tissueBiological
Also called Lipogems
Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.
Lipogems systemDevice
Also called Lipogems technological process
The Lipogems® system is a non-enzymatic method to obtain micro-fragmented adipose tissue from the abdominal region or thighs for injection into the injury site.
| Study group | Role | What they receive |
|---|---|---|
| Autologous micro-fragmented adipose tissue | Experimental | Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system. Receives: Biological: Autologous micro-fragmented adipose tissue; Device: Lipogems system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Shoulder pain intensity will also be assessed weekly using a numerical rating scale (NRS). Subjects will be asked to rate their average pain, most severe pain, and least severe pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Secondary outcomes (4)
Wheelchair User's Shoulder Pain Index (WUSPI)
The WUSPI is a 15-item self-report instrument that measures shoulder pain intensity in wheelchair users during various ADLs, such as transfers, loading a wheelchair into a car, wheelchair mobility, dressing, bathing, overhead lifting, driving, performing household chores, and sleeping. Each item is scored using a 10cm visual analog scale (VAS) which is anchored at the ends with "no pain" and "worst pain ever experienced." Individual item scores are summed to arrive at a total index score, which ranges from 0 to 150.
Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Patient Global Impression of Change
Subjects will be asked to rate on a 7-point scale overall impression following treatment as compared to the previous measurement interval. The 7-point PGIC scale (anchored by "very much improved" and "very much worse") is used to measure global treatment effect.
Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Brief Pain Inventory interference items (BPI-I7)
The Brief Pain Inventory (BPI) was developed by Cleeland, and has been used in a number of investigations of chronic pain. Its pain interference subscale has been used in several investigations of pain in SCI. In its original version the subscale (BPI-I7) consisted of 7 items measuring interference with general activity, sleep, mood, relationships, etc.). For uses with an SCI sample, in item 3 of BPI-I7, ''walking ability'' is replaced by "ability to get around."
Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Physical Examination of the Shoulder Score (PESS)
The Physical Examination of the Shoulder Score (PESS) is obtained by performing a series of eleven commonly used physical examination maneuvers for rotator cuff disease and shoulder pain that are graded 0 (no pain), 1 (equivocal for pain), or 2 (pain present).
Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start14 Jul 2017
- Primary completion6 Sep 2019
- Study completion21 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Dyson-Hudson, M.D., Kessler Foundation
- Investigators
- Trevor A. Dyson-Hudson, M.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167138
- Sponsor's protocol ID
- R-957-17
- Status last verified
- Feb 2020
- First submitted
- 24 May 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hogaboom N, Malanga G, Cherian C, Dyson-Hudson T. A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. J Spinal Cord Med. 2021 Nov;44(6):886-895. doi: 10.1080/10790268.2021.1903140. Epub 2021 Apr 8.
PubMed 33830898
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT03167138
- Acronym / sponsor ID
- R-957-17
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Spinal Cord Injuries
- Keywords
- Shoulder pain, Rotator cuff disease, Spinal cord injuries, Mesenchymal stromal cells, Regenerative medicine, Rehabilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 21 Feb 2020 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.
Detailed description
This is an exploratory pilot study to determine the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic, nonresponsive shoulder pain due to rotator cuff disease (i.e., rotator cuff tendinopathy) in persons with spinal cord injury (SCI). Twelve (12) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment who are diagnosed with rotator cuff disease on examination. Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. The final product will consist of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. Approximately 6 mL of micro-fragmented adipose will be injected into the tendon with a 22-gauge needle under continuous ultrasound guidance. No other biological or pharmacological agents will be used in combination with the micro-fragmented adipose. After 24 hours, subjects will be given a standardized stretching protocol to follow for 4 weeks followed by a formal strengthening program. Participants will be followed for adverse events and changes in shoulder pain intensity on an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine"); the Wheelchair User's Shoulder Pain Index (WUSPI; 15-item disease-specific functional measure of shoulder pain in persons with SCI); the Brief Pain Inventory interference items (BPI-I7; a subscale of 7 items measuring interference with general activity, sleep, mood, relationships, etc.); and a 5-point subject global impression of change (SGIC) scale. Subjects will be examined at 1 month, 2 months, 3 months, and 6 months after the treatment. Follow-up shoulder ultrasound will be performed at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Autologous micro-fragmented adipose tissue | Experimental | Biological: Autologous micro-fragmented adipose tissue, Device: Lipogems systemInjection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is male or female, 18 to 60 years of age, inclusive.
- The subject has neurological impairment secondary to a spinal cord injury that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C5 and L5, inclusive.
- The subject is non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (> 40 hours/week).
- The subject currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment (Note: rotator cuff disease will be defined as pain over the anterior shoulder, with direct palpation and pain at the shoulder with provocative tests for rotator cuff disease that is confirmed by tendinopathic changes on ultrasound imaging).
- The average shoulder pain intensity during the week leading up to the Screening Visit should be at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Key exclusion criteria (6 listed)
- The subject reports prior Lipogems treatment in the same shoulder.
- The subject reports a history of systemic disorders, such as diabetes or rheumatoid arthritis.
- The subject has contra-indications to the procedure, such as infection, coagulopathy, or is currently taking anti-coagulants.
- The subject reports having a glucocorticoid injection in the past 4 weeks.
- The subject is pregnant (documented by a urine pregnancy test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous micro-fragmented adipose tissueAlso: LipogemsMicro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance. | Biological | Autologous micro-fragmented adipose tissue |
| Lipogems systemAlso: Lipogems technological processThe Lipogems® system is a non-enzymatic method to obtain micro-fragmented adipose tissue from the abdominal region or thighs for injection into the injury site. | Device | Autologous micro-fragmented adipose tissue |
Primary outcome
Numerical Rating Scale
Time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Shoulder pain intensity will also be assessed weekly using a numerical rating scale (NRS). Subjects will be asked to rate their average pain, most severe pain, and least severe pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
4 secondary outcomes
Wheelchair User's Shoulder Pain Index (WUSPI)
Time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Patient Global Impression of Change
Time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Brief Pain Inventory interference items (BPI-I7)
Time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Physical Examination of the Shoulder Score (PESS)
Time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 33830898Hogaboom N, Malanga G, Cherian C, Dyson-Hudson T. A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. J Spinal Cord Med. 2021 Nov;44(6):886-895. doi: 10.1080/10790268.2021.1903140. Epub 2021 Apr 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor A. Dyson-Hudson, M.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous micro-fragmented adipose tissue and Lipogems system in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.