Low Back Pain, RecurrentNCT04415021
Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain
A study testing Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques in people with Low Back Pain, Recurrent, run by Ümit SIĞLAN at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 6 Jan 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with chronic low back pain diagnosed by the physician between the ages of 20-50
- Both genders
- People who have low back pain for 3 months or more
- Persons who have not received physical therapy application for the past 6 months, who have not used analgesics and non-streoids
- Volunteer patients
Who cannot join
- Having had surgery for the lumbar region or had a surgical diagnosis
- Spondylolisthesis and inflammatory symptoms in the spine
- Pregnant patients
- Other contraindicated conditions determined by the physician:
- Those with systemic infections
- Those with undiagnosed breathing difficulties
- Those with undiagnosed bowel and bladder problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain: A Randomized Controlled Study
The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain.
Read the detailed description
Low back pain is a common health problem that can be seen as a symptom and symptom of many diseases in the clinic.
Myofascial release technique is thought to be effective in patients with chronic low back pain. Therefore, when the literature is examined, it has been observed that the myofascial release technique has studies on pain, range of motion, functionality, muscle stiffness and shortness.
This study will be performed on patients with a total of 42 low back pain. The cases will be divided into 2 groups of 21 people by simple random sampling.
Group 1 (control) will be used with sham diaphragm and iliopsoas muscle myofascial release technique and traditional physiotherapy method.
The second group (experiment) will apply the diaphragm and the myofascial release technique of the iliopsoas muscle and the traditional physiotherapy method.
Patients will be treated for 4 weeks. Traditional physiotherapy method will be applied a total of 20 sessions 5 days a week. A total of 12 sessions will be performed, with the myofascial release technique of the diaphragm and iliopsoas muscle applied 3 days a week.
The study focuses on the analysis of the following variables:
Pain : Numerical Pain Scale
Joint Range of Motion: Goniometer
Flexibility: Tape Measure
Pulmonary Function Test: Spirometer
Anxiety and Depression: Beck Depression inventory
Kinesiophobia: Tampa Kinesiophobia Scale
Disability: Roland-Morris Disability Questionnaire
The results of these pre-intervention and post-intervention variables will be compared between the two groups .
- Conditions
- Low Back Pain, Recurrent
- Being tested
- Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques, Sham Comparator: Sham Myofascial Release Techniques
- Keywords
- Low Back Pain, Diaphragm, iliopsoas, Myofascial Release
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Diaphragmatic and İliopsoas Myofascial Release TechniquesOther
Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.
Sham Comparator: Sham Myofascial Release TechniquesOther
Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic and İliopsoas Myofascial Release Techniques | Experimental | Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles. Receives: Other: Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques |
| Sham Myofascial Release Techniques | Sham comparator | Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus. Receives: Other: Sham Comparator: Sham Myofascial Release Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in range of motin on goniometer at 4 weeks
The goniometer is an instrument which measures the available range of motion at a joint. If a patient or client is suffering from decreased range of motion in a particular joint, the therapist can use a goniometer to assess what the range of motion is at the initial assessment, and then make sure the intervention is working by using the goniometer in subsequent sessions.
Measured: Baseline and 4 weeks
Change from baseline in flexibility on tape measure at 4 weeks
Tape Measure. This test is used to assess the degree of flexibility of the lumbal region.
Measured: Baseline and 4 weeks
Change from baseline in pulmonary function test on the spirometer at 4 weeks
Spirometer. A spirometer is the main piece of equipment used for basic Pulmonary Function Tests (PFTs). Lung diseases such as asthma, bronchitis, and emphysema can be ruled out from the tests. In addition, a spirometer is often used for finding the cause of shortness of breath, assessing the effect of contaminants on lung function, the effect of medication, and evaluating progress for disease treatment
Measured: Baseline and 4 weeks
Change from baseline in pain on the Numeric Rating Scale at 4 weeks
The Numeric Rating Scale. This scale is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older.
Measured: Baseline and 4 weeks
Secondary outcomes (3)
Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks
Tampa Scale of Kinesiophobia .This scale is used to assess the patients' fear of pain or re-injury due to movement. It consists of 17 items and assesses various factors of fear/avoidance and injury/re-injury in several activities. Total score of the scale varies between 17 and 68 and higher scores represent higher levels of kinesiophobia.
Measured: Baseline and 4 weeks
Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks
The Roland-Morris Disability Questionnaire. This questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The Roland-Morris Disability Questionnaire has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain.
Measured: Baseline and 4 weeks
Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .
The Beck Depression Inventory.This inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Feb 2020
- Primary completion28 Jul 2020
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ümit SIĞLAN
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Sponsor-investigator, Ümit SIĞLAN, Istanbul Medipol University Hospital
- Investigators
- ÜMİT SIĞLAN, Study chair, İstanbulMUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415021
- Sponsor's protocol ID
- 10840098-604.01.01-E.1060
- Status last verified
- May 2022
- First submitted
- 27 May 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
PubMed 23725488Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PubMed 25603749Kolar 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 22236541Janssens 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 23727158Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
PubMed 27333481Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
PubMed 30368336Nachemson A. Electromyographic studies on the vertebral portion of the psoas muscle; with special reference to its stabilizing function of the lumbar spine. Acta Orthop Scand. 1966;37(2):177-90. doi: 10.3109/17453676608993277. No abstract available.
PubMed 5911492Park RJ, Tsao H, Claus A, Cresswell AG, Hodges PW. Recruitment of discrete regions of the psoas major and quadratus lumborum muscles is changed in specific sitting postures in individuals with recurrent low back pain. J Orthop Sports Phys Ther. 2013 Nov;43(11):833-40. doi: 10.2519/jospt.2013.4840. Epub 2013 Oct 11.
PubMed 24175597Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.
PubMed 25550670Stefanidi AV, Skoromets AA, Dukhovnikova IM. [Acute myofascial low back pain as a consequence of functional disorganization between flexors and extensors of the body]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(6):33-7. Russian.
PubMed 19672224Savage RA, Whitehouse GH, Roberts N. The relationship between the magnetic resonance imaging appearance of the lumbar spine and low back pain, age and occupation in males. Eur Spine J. 1997;6(2):106-14. doi: 10.1007/BF01358742.
PubMed 9209878Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
PubMed 36775506
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04415021
- Acronym / sponsor ID
- 10840098-604.01.01-E.1060
- Conditions
- Low Back Pain, Recurrent
- Keywords
- Low Back Pain, Diaphragm, iliopsoas, Myofascial Release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ümit SIĞLANUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 4 Jun 2020 (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.
The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain.
Detailed description
Low back pain is a common health problem that can be seen as a symptom and symptom of many diseases in the clinic.
Myofascial release technique is thought to be effective in patients with chronic low back pain. Therefore, when the literature is examined, it has been observed that the myofascial release technique has studies on pain, range of motion, functionality, muscle stiffness and shortness.
This study will be performed on patients with a total of 42 low back pain. The cases will be divided into 2 groups of 21 people by simple random sampling.
Group 1 (control) will be used with sham diaphragm and iliopsoas muscle myofascial release technique and traditional physiotherapy method.
The second group (experiment) will apply the diaphragm and the myofascial release technique of the iliopsoas muscle and the traditional physiotherapy method.
Patients will be treated for 4 weeks. Traditional physiotherapy method will be applied a total of 20 sessions 5 days a week. A total of 12 sessions will be performed, with the myofascial release technique of the diaphragm and iliopsoas muscle applied 3 days a week.
The study focuses on the analysis of the following variables:
Pain : Numerical Pain Scale
Joint Range of Motion: Goniometer
Flexibility: Tape Measure
Pulmonary Function Test: Spirometer
Anxiety and Depression: Beck Depression inventory
Kinesiophobia: Tampa Kinesiophobia Scale
Disability: Roland-Morris Disability Questionnaire
The results of these pre-intervention and post-intervention variables will be compared between the two groups .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic and İliopsoas Myofascial Release Techniques | Experimental | Other: Experimental: Diaphragmatic and İliopsoas Myofascial Release TechniquesSubjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles. |
| Sham Myofascial Release Techniques | Sham comparator | Other: Sham Comparator: Sham Myofascial Release TechniquesSubjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with chronic low back pain diagnosed by the physician between the ages of 20-50
- Both genders
- People who have low back pain for 3 months or more
- Persons who have not received physical therapy application for the past 6 months, who have not used analgesics and non-streoids
- Volunteer patients
Key exclusion criteria (7 listed)
- Having had surgery for the lumbar region or had a surgical diagnosis
- Spondylolisthesis and inflammatory symptoms in the spine
- Pregnant patients
- Other contraindicated conditions determined by the physician:
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 |
|---|---|---|
| Experimental: Diaphragmatic and İliopsoas Myofascial Release TechniquesSubjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles. | Other | Diaphragmatic and İliopsoas Myofascial Release Techniques |
| Sham Comparator: Sham Myofascial Release TechniquesSubjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus. | Other | Sham Myofascial Release Techniques |
Primary outcome
Change from baseline in range of motin on goniometer at 4 weeks
Time frame: Baseline and 4 weeks
The goniometer is an instrument which measures the available range of motion at a joint. If a patient or client is suffering from decreased range of motion in a particular joint, the therapist can use a goniometer to assess what the range of motion is at the initial assessment, and then make sure the intervention is working by using the goniometer in subsequent sessions.
Change from baseline in flexibility on tape measure at 4 weeks
Time frame: Baseline and 4 weeks
Tape Measure. This test is used to assess the degree of flexibility of the lumbal region.
Change from baseline in pulmonary function test on the spirometer at 4 weeks
Time frame: Baseline and 4 weeks
Spirometer. A spirometer is the main piece of equipment used for basic Pulmonary Function Tests (PFTs). Lung diseases such as asthma, bronchitis, and emphysema can be ruled out from the tests. In addition, a spirometer is often used for finding the cause of shortness of breath, assessing the effect of contaminants on lung function, the effect of medication, and evaluating progress for disease treatment
Change from baseline in pain on the Numeric Rating Scale at 4 weeks
Time frame: Baseline and 4 weeks
The Numeric Rating Scale. This scale is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older.
3 secondary outcomes
Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks
Time frame: Baseline and 4 weeks
Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks
Time frame: Baseline and 4 weeks
Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .
Time frame: Baseline and 4 weeks
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 26 May 2022.
- Results publication: PubMed 23725488McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
- Results publication: PubMed 25603749Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
- Results publication: PubMed 22236541Kolar 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.
- Results publication: 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.
- Results publication: PubMed 27333481Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
- Results publication: PubMed 30368336Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
- Results publication: PubMed 5911492Nachemson A. Electromyographic studies on the vertebral portion of the psoas muscle; with special reference to its stabilizing function of the lumbar spine. Acta Orthop Scand. 1966;37(2):177-90. doi: 10.3109/17453676608993277. No abstract available.
- Results publication: PubMed 24175597Park RJ, Tsao H, Claus A, Cresswell AG, Hodges PW. Recruitment of discrete regions of the psoas major and quadratus lumborum muscles is changed in specific sitting postures in individuals with recurrent low back pain. J Orthop Sports Phys Ther. 2013 Nov;43(11):833-40. doi: 10.2519/jospt.2013.4840. Epub 2013 Oct 11.
- Results publication: PubMed 25550670Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.
- Results publication: PubMed 19672224Stefanidi AV, Skoromets AA, Dukhovnikova IM. [Acute myofascial low back pain as a consequence of functional disorganization between flexors and extensors of the body]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(6):33-7. Russian.
- Results publication: PubMed 9209878Savage RA, Whitehouse GH, Roberts N. The relationship between the magnetic resonance imaging appearance of the lumbar spine and low back pain, age and occupation in males. Eur Spine J. 1997;6(2):106-14. doi: 10.1007/BF01358742.
- Derived from this study: PubMed 36775506Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
- 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.
ÜMİT SIĞLAN study chair
İstanbulMUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques in people with Low Back Pain, Recurrent, run by Ümit SIĞLAN 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 5 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 26 May 2022. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in range of motin on goniometer at 4 weeks (time frame: Baseline and 4 weeks). The study lists 4 primary outcomes in all. 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 NCT04415021, which also lists 12 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 26 May 2022.