Rotator Cuff TearsPhase 4NCT06367998
Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair
A Phase 4 study testing Pregabalin in people with Rotator Cuff Tears and Central Sensitisation, run by The Catholic University of Korea.
Trial summary
This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for… Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Central Sensitisation, Neuropathic Pain
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 May 2026
- Phase
- Phase 4
- 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 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 19 to under 70
- Underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff.
- Clinical diagnosis of myofascial pain syndrome
- Central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).
Who cannot join
- Previous history of Pregabalin prescription
- Hypersensitivity reactions or severe complications after taking Pregabalin.
- Diagnosed with and are being treated for psychiatric disorders
- Localized infection, sepsis, or previous neurological abnormalities
- Uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmHg)
- Liver function abnormalities (aspartate aminotransferase or alanine aminotransferase \>60 IU/litre).
- major cardiovascular diseases or renal impairments
About this study
Official title: The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair
This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.
The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.
- Conditions
- Rotator Cuff Tears, Central Sensitisation, Neuropathic Pain
- Being tested
- Pregabalin
- Medical subject headings
- Rotator Cuff Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin oral intake from the day before surgery to six weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Experimental | Not described Receives: Drug: Pregabalin |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale (VAS) pain score
Pain score evaluation from 0 to 10, 10 meaning the maximum pain
Measured: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months
Secondary outcomes (2)
Constant shoulder score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
Measured: Preoperative, postoperative 6 months and 12 months
American shouler and elbow surgeons (ASES) score
Shoulder functional score from 0 to 100, 100 meaning excellent shoulder function
Measured: Preoperative, postoperative 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Korea
- Responsible party
- Principal investigator, Hyungsuk Kim, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367998
- Sponsor's protocol ID
- PC24MISV0017
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregabalin on Shoulder Pain of Patients With Myofascial Pain Syndrome and Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06367998
- Acronym / sponsor ID
- PC24MISV0017
- Conditions
- Rotator Cuff Tears, Central Sensitisation, Neuropathic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Viatris Korea
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Apr 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 study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.
The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Experimental | Drug: Pregabalin |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 19 to under 70
- Underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff.
- Clinical diagnosis of myofascial pain syndrome
- Central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).
Key exclusion criteria (7 listed)
- Previous history of Pregabalin prescription
- Hypersensitivity reactions or severe complications after taking Pregabalin.
- Diagnosed with and are being treated for psychiatric disorders
- Localized infection, sepsis, or previous neurological abnormalities
- Uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmHg)
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 |
|---|---|---|
| PregabalinAlso: LyricaPregabalin oral intake from the day before surgery to six weeks postoperatively | Drug | Pregabalin group |
Primary outcome
The Visual Analogue Scale (VAS) pain score
Time frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months
Pain score evaluation from 0 to 10, 10 meaning the maximum pain
2 secondary outcomes
Constant shoulder score
Time frame: Preoperative, postoperative 6 months and 12 months
American shouler and elbow surgeons (ASES) score
Time frame: Preoperative, postoperative 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Rotator Cuff Tears and Central Sensitisation, run by The Catholic University of Korea.
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 4 inclusion and 7 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The Visual Analogue Scale (VAS) pain score (time frame: Preoperative, postoperative 2, 6 weeks, 2, 4, 6 and 12 months). 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 23 Aug 2024.