Shoulder PainNCT06467123
A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain
A study testing Tissue Intervention and Biopsychosocial Intervention in people with Shoulder Pain, run by University of Central Florida at 1 site in United States.
Trial summary
This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Tissue Intervention and Biopsychosocial Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 28 Feb 2025
- Phase
- Interventional
- 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
- Shoulder pain intensity rated as 3/10 or higher in the past 24 hours
Who cannot join
- Non-English speaking
- Systemic medical conditions that affect sensation, such as uncontrolled diabetes
- History of shoulder surgery or fracture within the past 6 months
- blood clotting disorder, such as hemophilia
- contraindication to the application of ice ((blood pressure > 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
- Unable to exercise without a medical clearance (assessed on the PAR-Q+ on the first visit)
Show all 10Show fewer
- Exceed pressure and sensory safety thresholds (assessed on the first visit)
- Categorized as low irritability (assessed on the first visit)
- currently pregnant
- currently receiving physical therapy to treat shoulder pain
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32765
About this study
This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.
- Conditions
- Shoulder Pain
- Being tested
- Tissue Intervention, Biopsychosocial Intervention
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue InterventionOther
Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.
Biopsychosocial InterventionOther
Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| Tissue Intervention | Experimental | Participants will attend eight sessions. During each session, participants will receive education on positions of comfort, progressing activities, and return to function. Participants will complete shoulder stretching and strengthening exercises according to a protocol. Receives: Other: Tissue Intervention |
| Biopsychosocial Intervention | Active comparator | Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol. Receives: Other: Biopsychosocial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report rate of adherence and adverse effects
Number of participants who complete the study and adverse events will be reported
Measured: through study completion, 4 weeks
Report preliminary outcomes of treatment effects
Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups.
Measured: through study completion, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start28 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Wilson, University of Central Florida
- Investigators
- Abigail Anderson, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467123
- Sponsor's protocol ID
- 9
- Status last verified
- Feb 2025
- First submitted
- 14 Jun 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain
- ClinicalTrials.gov ID
- NCT06467123
- Acronym / sponsor ID
- 9
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Jun 2024 (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.
This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Intervention | Experimental | Other: Tissue InterventionParticipants will attend eight sessions. During each session, participants will receive education on positions of comfort, progressing activities, and return to function. Participants will complete shoulder stretching and strengthening exercises according to a protocol. |
| Biopsychosocial Intervention | Active comparator | Other: Biopsychosocial InterventionParticipants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Shoulder pain intensity rated as 3/10 or higher in the past 24 hours
Key exclusion criteria (10 listed)
- Non-English speaking
- Systemic medical conditions that affect sensation, such as uncontrolled diabetes
- History of shoulder surgery or fracture within the past 6 months
- blood clotting disorder, such as hemophilia
- contraindication to the application of ice ((blood pressure > 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
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 |
|---|---|---|
| Tissue InterventionParticipants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol. | Other | Tissue Intervention |
| Biopsychosocial InterventionParticipants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol. | Other | Biopsychosocial Intervention |
Primary outcome
Report rate of adherence and adverse effects
Time frame: through study completion, 4 weeks
Number of participants who complete the study and adverse events will be reported
Report preliminary outcomes of treatment effects
Time frame: through study completion, 4 weeks
Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Abigail Anderson principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Intervention and Biopsychosocial Intervention in people with Shoulder Pain, run by University of Central Florida 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 1 inclusion and 10 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 5 Mar 2025. 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.
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?
Report rate of adherence and adverse effects (time frame: through study completion, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.