Adolescent Idiopathic ScoliosisNCT05311826
Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.
A study testing STANDARD PHYSIOTHERAPY TREATMENT and EXPERIMENTAL diaphragmatic breathing exercise in people with Adolescent Idiopathic Scoliosis and Spinal Fusion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management. The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Spinal Fusion, Pain Management
- What is being tested?
- STANDARD PHYSIOTHERAPY TREATMENT and EXPERIMENTAL diaphragmatic breathing exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jun 2022to 15 May 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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled.
Who cannot join
- Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Postoperative Respiratory Physiotherapy for Pain Management in Patients Undergoing Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Study
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of 2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both physical and psychological domains, interfering with self-esteem and mental well-being. Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be a stressful intervention for patients and their caregivers.
Postoperative pain is the major concern for patients undergoing orthopedic surgery. Significant postoperative pain also adversely affects other outcomes by hindering the healing process and delaying rehabilitation with loss of movement and walking. After arthrodesis the pain reported by the patients is significant.
Various strategies have been explored for acute pain management in patients undergoing surgery for scoliosis, with a focus on the first days post surgery. The link between breathing, lumbar spine function and pain perception is an aspect that has always been studied. The diaphragm plays an important role in spinal control and in the management of pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce significant and clinically relevant improvements in the treatment of pathologies of the spine and especially in the management of painful symptoms.
A systematic review highlights how pain is able to influence the flow, frequency and volume of the respiratory act. At the same time, a regulation of breathing can be an useful tool in the control of painful symptoms.
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe tool that can be introduced for the control of painful symptoms.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative phase in patients undergoing arthrodesis surgery for adolescent idiopathic scoliosis.
- Being tested
- STANDARD PHYSIOTHERAPY TREATMENT, EXPERIMENTAL diaphragmatic breathing exercise
- Keywords
- spinal fusion, early rehabilitation, diaphragmatic breathing exercise, Adolescent Idiopathic Scoliosis
- Medical subject headings
- Agnosia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARD PHYSIOTHERAPY TREATMENTProcedure or surgery
The standard postoperative rehabilitation process starts from the first postoperative day. Two sessions are provided daily, with the exception of Sunday and Saturday afternoon. A single physiotherapy session, lasting 30 minutes, can include bed exercises for upper and lower limbs and recovery of autonomy (sitting position, standing and ambulation). In this phase, the sessions are characterized by educational and counseling activities.
The patient will be encouraged to carry out the activities independently.
EXPERIMENTAL diaphragmatic breathing exerciseProcedure or surgery
The subjects in the intervention group (EXP) will receive, in addition to standard physiotherapy treatment, diaphragmatic breathing exercise. Four exercises in different position (supine and side lying) will be provided for each physiotherapy session by a senior physiotherapist. Patients will be instructed to perform the same exercises independently to achieve relaxation and relief of pain symptoms.
| Study group | Role | What they receive |
|---|---|---|
| STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP | Active comparator | Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis. Receives: Procedure: STANDARD PHYSIOTHERAPY TREATMENT |
| EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP | Experimental | Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis. Receives: Procedure: EXPERIMENTAL diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of pain
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
Measured: The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.
Secondary outcomes (2)
intensity of pain (short term)
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
Measured: the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day
TUG - Time Up and Go
Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.
Measured: the TUG test will be administered during the 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start29 Jun 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- antonio culcasi, PT, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311826
- Sponsor's protocol ID
- RachideResp
- Status last verified
- Jun 2024
- First submitted
- 26 Mar 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lotan S, Kalichman L. Manual therapy treatment for adolescent idiopathic scoliosis. J Bodyw Mov Ther. 2019 Jan;23(1):189-193. doi: 10.1016/j.jbmt.2018.01.005. Epub 2018 Feb 3.
PubMed 30691751Agabegi SS, Kazemi N, Sturm PF, Mehlman CT. Natural History of Adolescent Idiopathic Scoliosis in Skeletally Mature Patients: A Critical Review. J Am Acad Orthop Surg. 2015 Dec;23(12):714-23. doi: 10.5435/JAAOS-D-14-00037. Epub 2015 Oct 28.
PubMed 26510624Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410.
PubMed 11481590Sjoling M, Nordahl G, Olofsson N, Asplund K. The impact of preoperative information on state anxiety, postoperative pain and satisfaction with pain management. Patient Educ Couns. 2003 Oct;51(2):169-76. doi: 10.1016/s0738-3991(02)00191-x.
PubMed 14572947Ballantyne JC, Carr DB, deFerranti S, Suarez T, Lau J, Chalmers TC, Angelillo IF, Mosteller F. The comparative effects of postoperative analgesic therapies on pulmonary outcome: cumulative meta-analyses of randomized, controlled trials. Anesth Analg. 1998 Mar;86(3):598-612. doi: 10.1097/00000539-199803000-00032.
PubMed 9495424Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
PubMed 15763409Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
PubMed 8930721Vitale MG, Choe JC, Hwang MW, Bauer RM, Hyman JE, Lee FY, Roye DP Jr. Use of ketorolac tromethamine in children undergoing scoliosis surgery. an analysis of complications. Spine J. 2003 Jan-Feb;3(1):55-62. doi: 10.1016/s1529-9430(02)00446-1.
PubMed 14589246Wong GT, Yuen VM, Chow BF, Irwin MG. Persistent pain in patients following scoliosis surgery. Eur Spine J. 2007 Oct;16(10):1551-6. doi: 10.1007/s00586-007-0361-7. Epub 2007 Apr 5.
PubMed 17410382Kotzer AM. Factors predicting postoperative pain in children and adolescents following spine fusion. Issues Compr Pediatr Nurs. 2000 Apr-Jun;23(2):83-102. doi: 10.1080/01460860050121411.
PubMed 11111499Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
PubMed 21939499Janssens L, Brumagne S, McConnell AK, Hermans G, Troosters T, Gayan-Ramirez G. Greater diaphragm fatigability in individuals with recurrent low back pain. Respir Physiol Neurobiol. 2013 Aug 15;188(2):119-23. doi: 10.1016/j.resp.2013.05.028. Epub 2013 May 31.
PubMed 23727158Bordoni B, Marelli F. Failed back surgery syndrome: review and new hypotheses. J Pain Res. 2016 Jan 12;9:17-22. doi: 10.2147/JPR.S96754. eCollection 2016.
PubMed 26834497Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21.
PubMed 22236541Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
PubMed 29787734
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Postoperative Respiratory Physiotherapy for Pain Management in Patients Undergoing Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05311826
- Acronym / sponsor ID
- RachideResp
- Keywords
- spinal fusion, early rehabilitation, diaphragmatic breathing exercise, Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 5 Apr 2022 (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.
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of 2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both physical and psychological domains, interfering with self-esteem and mental well-being. Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be a stressful intervention for patients and their caregivers.
Postoperative pain is the major concern for patients undergoing orthopedic surgery. Significant postoperative pain also adversely affects other outcomes by hindering the healing process and delaying rehabilitation with loss of movement and walking. After arthrodesis the pain reported by the patients is significant.
Various strategies have been explored for acute pain management in patients undergoing surgery for scoliosis, with a focus on the first days post surgery. The link between breathing, lumbar spine function and pain perception is an aspect that has always been studied. The diaphragm plays an important role in spinal control and in the management of pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce significant and clinically relevant improvements in the treatment of pathologies of the spine and especially in the management of painful symptoms.
A systematic review highlights how pain is able to influence the flow, frequency and volume of the respiratory act. At the same time, a regulation of breathing can be an useful tool in the control of painful symptoms.
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe tool that can be introduced for the control of painful symptoms.
The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative phase in patients undergoing arthrodesis surgery for adolescent idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP | Active comparator | Procedure: STANDARD PHYSIOTHERAPY TREATMENTPatients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis. |
| EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP | Experimental | Procedure: EXPERIMENTAL diaphragmatic breathing exercisePatients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled.
Key exclusion criteria (1 listed)
- Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.
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 |
|---|---|---|
| STANDARD PHYSIOTHERAPY TREATMENTThe standard postoperative rehabilitation process starts from the first postoperative day. Two sessions are provided daily, with the exception of Sunday and Saturday afternoon. A single physiotherapy session, lasting 30 minutes, can include bed exercises for upper and lower limbs and recovery of autonomy (sitting position, standing and ambulation). In this phase, the sessions are characterized by educational and counseling activities. The patient will be encouraged to carry out the activities independently. | Procedure or surgery | STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP |
| EXPERIMENTAL diaphragmatic breathing exerciseThe subjects in the intervention group (EXP) will receive, in addition to standard physiotherapy treatment, diaphragmatic breathing exercise. Four exercises in different position (supine and side lying) will be provided for each physiotherapy session by a senior physiotherapist. Patients will be instructed to perform the same exercises independently to achieve relaxation and relief of pain symptoms. | Procedure or surgery | EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP |
Primary outcome
intensity of pain
Time frame: The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
2 secondary outcomes
intensity of pain (short term)
Time frame: the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day
TUG - Time Up and Go
Time frame: the TUG test will be administered during the 5th postoperative day
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 6 Jun 2024.
- Background: PubMed 30691751Lotan S, Kalichman L. Manual therapy treatment for adolescent idiopathic scoliosis. J Bodyw Mov Ther. 2019 Jan;23(1):189-193. doi: 10.1016/j.jbmt.2018.01.005. Epub 2018 Feb 3.
- Background: PubMed 26510624Agabegi SS, Kazemi N, Sturm PF, Mehlman CT. Natural History of Adolescent Idiopathic Scoliosis in Skeletally Mature Patients: A Critical Review. J Am Acad Orthop Surg. 2015 Dec;23(12):714-23. doi: 10.5435/JAAOS-D-14-00037. Epub 2015 Oct 28.
- Background: PubMed 11481590Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410.
- Background: PubMed 14572947Sjoling M, Nordahl G, Olofsson N, Asplund K. The impact of preoperative information on state anxiety, postoperative pain and satisfaction with pain management. Patient Educ Couns. 2003 Oct;51(2):169-76. doi: 10.1016/s0738-3991(02)00191-x.
- Background: PubMed 9495424Ballantyne JC, Carr DB, deFerranti S, Suarez T, Lau J, Chalmers TC, Angelillo IF, Mosteller F. The comparative effects of postoperative analgesic therapies on pulmonary outcome: cumulative meta-analyses of randomized, controlled trials. Anesth Analg. 1998 Mar;86(3):598-612. doi: 10.1097/00000539-199803000-00032.
- Background: PubMed 15763409Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
- Background: PubMed 8930721Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
- Background: PubMed 14589246Vitale MG, Choe JC, Hwang MW, Bauer RM, Hyman JE, Lee FY, Roye DP Jr. Use of ketorolac tromethamine in children undergoing scoliosis surgery. an analysis of complications. Spine J. 2003 Jan-Feb;3(1):55-62. doi: 10.1016/s1529-9430(02)00446-1.
- Background: PubMed 17410382Wong GT, Yuen VM, Chow BF, Irwin MG. Persistent pain in patients following scoliosis surgery. Eur Spine J. 2007 Oct;16(10):1551-6. doi: 10.1007/s00586-007-0361-7. Epub 2007 Apr 5.
- Background: PubMed 11111499Kotzer AM. Factors predicting postoperative pain in children and adolescents following spine fusion. Issues Compr Pediatr Nurs. 2000 Apr-Jun;23(2):83-102. doi: 10.1080/01460860050121411.
- Background: PubMed 21939499Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
- Background: PubMed 23727158Janssens L, Brumagne S, McConnell AK, Hermans G, Troosters T, Gayan-Ramirez G. Greater diaphragm fatigability in individuals with recurrent low back pain. Respir Physiol Neurobiol. 2013 Aug 15;188(2):119-23. doi: 10.1016/j.resp.2013.05.028. Epub 2013 May 31.
- 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.
antonio culcasi, PT principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD PHYSIOTHERAPY TREATMENT and EXPERIMENTAL diaphragmatic breathing exercise in people with Adolescent Idiopathic Scoliosis and Spinal Fusion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 1 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 6 Jun 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 Italy. 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?
intensity of pain (time frame: The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.). 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 NCT05311826, which also lists 26 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 6 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.