Rotator Cuff TearsNCT06088667
Fascial Release After Arthroscopic Rotator Cuff Repair
A study testing Fascial mobilization group in people with Rotator Cuff Tears, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Fascial mobilization group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Sep 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- 4 weeks have passed since arthroscopic rotator cuff repair
Who cannot join
- cervical discopathy,
- shoulder osteoarthritis
- fracture or tumor of the upper extremity,
- adhesive capsulitis,
- shoulder instability,
- thoracic outlet syndrome and
- patients with neurological or mental problems.
- Non-voluntary patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
About this study
Official title: The Effect of Fascial Release on Pain, Range of Motion and Functionality After Arthroscopic Rotator Cuff Repair
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.
Read the detailed description
Rotator cuff (RC) rupture causes shoulder pain, muscle weakness, and decreased shoulder range of motion (ROM). Additionally, fear of movement develops due to shoulder pain, affecting ROM and function. Treatment of RC rupture is initially conservative. In cases where conservative treatment is inadequate, surgical option is preferred. Open, mini-open and arthroscopic repair can be used in surgery. In recent years, arthroscopic repair has been mostly preferred because it causes less pain than other surgical options, has a shorter hospital stay, and does not cause complications. A postoperative rehabilitation program is a crucial component of surgical success. The aim of this program is to reduce pain, increase ROM, and improve patients' functional level and activities of daily living. The postoperative rehabilitation program includes electrophysical agents, manual therapy and exercise.Surgery-related inflammation may restrict fascial tissue. Inflammation changes the mechanical properties of connective tissue, causing adhesions and eventually leading to stiffness. Thus, the slip between fascial surfaces decreases and, accordingly, ROM and function decrease.
Instrument Assisted Soft Tissue Mobilization (IASTM) is used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. However, it is noteworthy that there is a lack of studies examining the long-term effectiveness of fascial mobilization in shoulder pathologies. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, range of motion, fear of movement, and daily living activities in patients 4 weeks after rotator cuff arthroscopic surgery.
- Conditions
- Rotator Cuff Tears
- Being tested
- Fascial mobilization group
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial mobilization groupOther
In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fascial mobilization group | Experimental | In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments. Receives: Other: Fascial mobilization group |
| Control Group | Experimental | The control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks. Receives: Other: Fascial mobilization group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Visuel analog scale will be used to evaluate individuals' shoulder pain level.
Measured: baseline and 4 weeks post-intervention
Secondary outcomes (3)
Range of motion
Joint range of motion will be assessed using a universal goniometer
Measured: baseline and 4 weeks post-intervention
Kinesiophobia
The Tampa Kinesiophobia Scale (TSK) will be used to measure individuals' fear of movement/reinjury.
Measured: baseline and 4 weeks post-intervention
Functional level
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate functional disability.
Measured: baseline and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Oct 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088667
- Sponsor's protocol ID
- Karabuk University 78
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pegreffi F, Paladini P, Campi F, Porcellini G. Conservative management of rotator cuff tear. Sports Med Arthrosc Rev. 2011 Dec;19(4):348-53. doi: 10.1097/JSA.0b013e3182148dc6.
PubMed 22089284Nikolaidou O, Migkou S, Karampalis C. Rehabilitation after Rotator Cuff Repair. Open Orthop J. 2017 Feb 28;11:154-162. doi: 10.2174/1874325001711010154. eCollection 2017.
PubMed 28400883Coban T, Demirdel E, Yildirim NU, Deveci A. The investigation of acute effects of fascial release technique in patients with arthroscopic rotator cuff repair: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101573. doi: 10.1016/j.ctcp.2022.101573. Epub 2022 Mar 21.
PubMed 35397305
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fascial Release on Pain, Range of Motion and Functionality After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06088667
- Acronym / sponsor ID
- Karabuk University 78
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 18 Oct 2023 (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.
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.
Detailed description
Rotator cuff (RC) rupture causes shoulder pain, muscle weakness, and decreased shoulder range of motion (ROM). Additionally, fear of movement develops due to shoulder pain, affecting ROM and function. Treatment of RC rupture is initially conservative. In cases where conservative treatment is inadequate, surgical option is preferred. Open, mini-open and arthroscopic repair can be used in surgery. In recent years, arthroscopic repair has been mostly preferred because it causes less pain than other surgical options, has a shorter hospital stay, and does not cause complications. A postoperative rehabilitation program is a crucial component of surgical success. The aim of this program is to reduce pain, increase ROM, and improve patients' functional level and activities of daily living. The postoperative rehabilitation program includes electrophysical agents, manual therapy and exercise.Surgery-related inflammation may restrict fascial tissue. Inflammation changes the mechanical properties of connective tissue, causing adhesions and eventually leading to stiffness. Thus, the slip between fascial surfaces decreases and, accordingly, ROM and function decrease.
Instrument Assisted Soft Tissue Mobilization (IASTM) is used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. However, it is noteworthy that there is a lack of studies examining the long-term effectiveness of fascial mobilization in shoulder pathologies. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, range of motion, fear of movement, and daily living activities in patients 4 weeks after rotator cuff arthroscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Fascial mobilization group | Experimental | Other: Fascial mobilization groupIn addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments. |
| Control Group | Experimental | Other: Fascial mobilization groupThe control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years old
- 4 weeks have passed since arthroscopic rotator cuff repair
Key exclusion criteria (8 listed)
- cervical discopathy,
- shoulder osteoarthritis
- fracture or tumor of the upper extremity,
- adhesive capsulitis,
- shoulder instability,
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 |
|---|---|---|
| Fascial mobilization groupIn addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks. | Other | Control Group, Fascial mobilization group |
Primary outcome
Pain severity
Time frame: baseline and 4 weeks post-intervention
Visuel analog scale will be used to evaluate individuals' shoulder pain level.
3 secondary outcomes
Range of motion
Time frame: baseline and 4 weeks post-intervention
Kinesiophobia
Time frame: baseline and 4 weeks post-intervention
Functional level
Time frame: baseline and 4 weeks post-intervention
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 15 Oct 2024.
- Background: PubMed 22089284Pegreffi F, Paladini P, Campi F, Porcellini G. Conservative management of rotator cuff tear. Sports Med Arthrosc Rev. 2011 Dec;19(4):348-53. doi: 10.1097/JSA.0b013e3182148dc6.
- Background: PubMed 28400883Nikolaidou O, Migkou S, Karampalis C. Rehabilitation after Rotator Cuff Repair. Open Orthop J. 2017 Feb 28;11:154-162. doi: 10.2174/1874325001711010154. eCollection 2017.
- Results publication: PubMed 35397305Coban T, Demirdel E, Yildirim NU, Deveci A. The investigation of acute effects of fascial release technique in patients with arthroscopic rotator cuff repair: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101573. doi: 10.1016/j.ctcp.2022.101573. Epub 2022 Mar 21.
- Individual participant dataSharing planned: No
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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 Fascial mobilization group in people with Rotator Cuff Tears, run by Karabuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 Oct 2024. 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 Turkey (Türkiye). 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 severity (time frame: baseline and 4 weeks post-intervention). 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 NCT06088667, which also lists 3 linked publications.
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 Oct 2024.