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Shoulder PainPhase 1NCT01355549

Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury

A Phase 1 study testing Platelet-rich plasma (PRP) therapy in people with Shoulder Pain and Rotator Cuff Tendinitis, run by Kessler Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Platelet-rich plasma (PRP) therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
May 2011to Nov 2012
Phase
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 60 years
  • All sexes
  • No healthy volunteers
  • 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 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

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

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.

Being tested
Platelet-rich plasma (PRP) therapy
Keywords
Shoulder pain, Rotator cuff disease, Spinal cord injuries, Platelet-rich plasma therapy, Rehabilitation
Medical subject headings
Shoulder Pain, 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.

  • Platelet-rich plasma (PRP) therapyBiological

    Also called Autologous blood injections

    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.

Study groups in NCT01355549
Study groupRoleWhat they receive
Platelet-rich plasma therapyExperimentalPlatelet 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.
Receives: Biological: Platelet-rich plasma (PRP) therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.

Secondary outcomes (4)

  1. 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 PRP treatment.

  2. 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 PRP treatment.

  3. 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."

    Measured: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.

  4. Rotator Cuff Disease Score

    Measured: Baseline and at the 12-Week and 24-Weeks Follow-up Visit after the PRP treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355549
Sponsor's protocol ID
R-677-10
Status last verified
Jan 2013
First submitted
16 May 2011
Last updated
15 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32379581

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Platelet-rich plasma (PRP) therapy in people with Shoulder Pain and Rotator Cuff Tendinitis, 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 6 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: finished, as of the sponsor's last update on 15 Jan 2013. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (NRS) (time frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP 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 NCT01355549, 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 15 Jan 2013.

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