Back to resultsPlatelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
Primary Purpose
Shoulder Pain, Rotator Cuff Tendinitis, Rotator Cuff Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP) therapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Rotator cuff disease, Spinal cord injuries, Platelet-rich plasma therapy, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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 C6 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. Average shoulder pain intensity during the week leading up to the Screening Visit should be at least 5 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable), in spite of a past history of completing 6 months of conservative treatment. 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 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.
Exclusion Criteria:
- The subject reports prior PRP 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.
Sites / Locations
- Kessler Institute for Rehabilitation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet-rich plasma therapy
Arm Description
Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
Outcomes
Primary Outcome Measures
Numerical Rating Scale (NRS)
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 "worst pain ever experienced." 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.
Secondary Outcome Measures
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.
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.
Brief Pain Inventory interference items (BPI-I)
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."
Rotator Cuff Disease Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355549
Brief Title
Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
Official Title
A Pilot Study to Evaluate the Feasibility of Platelet-Rich Plasma Therapy as a Treatment for Chronic Shoulder Pain in Persons With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by overuse injuries to the muscles and tendons that can occur during wheelchair propulsion, transfers, and other activities of daily living. Normally, shoulder pain resolves with conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery may be the only option.
Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood, cells within the blood called "platelets" are concentrated and then re-injected into the muscle and tendon of the shoulder. These platelets release substances known as "growth factors" that lead to tissue healing. By concentrating the platelets we increase the growth factors up to eight times which will promote the healing of tendons. PRP therapy has shown promise in treating tendon and muscle injuries in able-bodied persons; however, its effectiveness in persons with SCI is unknown. The purpose of this study is to explore the feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with SCI. The human body has a remarkable ability to heal itself and we hypothesize that re-injecting concentrated platelets will facilitate the natural healing process and will reduce shoulder pain in persons with SCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Rotator Cuff Tendinitis, Rotator Cuff Syndrome, Spinal Cord Injury
Keywords
Shoulder pain, Rotator cuff disease, Spinal cord injuries, Platelet-rich plasma therapy, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-rich plasma therapy
Arm Type
Experimental
Arm Description
Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma (PRP) therapy
Other Intervention Name(s)
Autologous blood injections
Intervention Description
Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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 "worst pain ever experienced." 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.
Time Frame
Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
Secondary Outcome Measure Information:
Title
Wheelchair User's Shoulder Pain Index (WUSPI)
Description
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.
Time Frame
Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
Title
Patient Global Impression of Change
Description
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.
Time Frame
Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
Title
Brief Pain Inventory interference items (BPI-I)
Description
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."
Time Frame
Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
Title
Rotator Cuff Disease Score
Time Frame
Baseline and at the 12-Week and 24-Weeks Follow-up Visit after the PRP treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 C6 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. Average shoulder pain intensity during the week leading up to the Screening Visit should be at least 5 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable), in spite of a past history of completing 6 months of conservative treatment. 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 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.
Exclusion Criteria:
The subject reports prior PRP 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor A. Dyson-Hudson, M.D.
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32379581
Citation
Dyson-Hudson TA, Hogaboom NS, Nakamura R, Terry A, Malanga GA. Ultrasound-guided platelet-rich plasma injection for the treatment of recalcitrant rotator cuff disease in wheelchair users with spinal cord injury: A pilot study. J Spinal Cord Med. 2022 Jan;45(1):42-48. doi: 10.1080/10790268.2020.1754676. Epub 2020 May 7.
Results Reference
derived
Learn more about this trial
Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
We'll reach out to this number within 24 hrs