Rotator Cuff InjuriesNCT04705311
The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
A study testing Pain neuroscience education and Rotator cuff repair rehabilitation in people with Rotator Cuff Injuries and Kinesiophobia, run by Sahmyook University at 1 site in South Korea.
Trial summary
During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative
- What is being tested?
- Pain neuroscience education and Rotator cuff repair rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2021to 31 Aug 2021
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old
- In case of 4 weeks after receiving arthroscopic rotator cuff repair
- If you wish to participate in research
Who cannot join
- 65 years old or older
- Those who are limited in conducting education remotely
- If the tear area is large and augmentation is performed
- If there is a previous surgical history at the surgical site
- Osteoarthritis in the shoulder joint
- If you cannot understand the guidelines for evaluation or intervention
- Mental health and cognitive problems
Trial locations and contacts
1 site in 1 country.
About this study
During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.
- Conditions
- Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative
- Being tested
- Pain neuroscience education, Rotator cuff repair rehabilitation
- Medical subject headings
- Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
Neurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models.
Rotator cuff repair rehabilitationBehavioural
Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
| Study group | Role | What they receive |
|---|---|---|
| pain neuroscience education plus rotator cuff repair rehabilitation | Experimental | Not described Receives: Other: Pain neuroscience education; Behavioral: Rotator cuff repair rehabilitation |
| rotator cuff repair rehabilitation | Active comparator | Not described Receives: Behavioral: Rotator cuff repair rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.
Measured: Change in pain intensity from baseline to weeks 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start10 Feb 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705311
- Sponsor's protocol ID
- 2-1040781-A-N-012021010HR
- Status last verified
- Sep 2021
- First submitted
- 8 Jan 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04705311
- Acronym / sponsor ID
- 2-1040781-A-N-012021010HR
- Conditions
- Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 12 Jan 2021 (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.
During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain neuroscience education plus rotator cuff repair rehabilitation | Experimental | Other: Pain neuroscience education, Behavioral: Rotator cuff repair rehabilitation |
| rotator cuff repair rehabilitation | Active comparator | Behavioral: Rotator cuff repair rehabilitation |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years old
- In case of 4 weeks after receiving arthroscopic rotator cuff repair
- If you wish to participate in research
Key exclusion criteria (7 listed)
- 65 years old or older
- Those who are limited in conducting education remotely
- If the tear area is large and augmentation is performed
- If there is a previous surgical history at the surgical site
- Osteoarthritis in the shoulder joint
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 |
|---|---|---|
| Pain neuroscience educationNeurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models. | Other | pain neuroscience education plus rotator cuff repair rehabilitation |
| Rotator cuff repair rehabilitationPostoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise. | Behavioural | pain neuroscience education plus rotator cuff repair rehabilitation, rotator cuff repair rehabilitation |
Primary outcome
Pain intensity
Time frame: Change in pain intensity from baseline to weeks 2, 4, and 6
A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.
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 17 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education and Rotator cuff repair rehabilitation in people with Rotator Cuff Injuries and Kinesiophobia, run by Sahmyook University at 1 site in South 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 3 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: finished, as of the sponsor's last update on 17 Sep 2021. 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 South Korea. 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?
Pain intensity (time frame: Change in pain intensity from baseline to weeks 2, 4, and 6). 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 17 Sep 2021.