FibromyalgiaFIT TeensNCT03268421
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia
A study testing Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy and Graded Aerobic Exercise in people with Fibromyalgia and Myofascial Pain Syndrome, run by Children's Hospital Medical Center, Cincinnati at 7 sites in 2 countries.
Trial summary
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases
- What is being tested?
- Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy and Graded Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 2 Jan 2018to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
- Functional Disability Score ≥ 13, indicating at least moderate disability
- Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale
- Stable medications prior to enrollment
Who cannot join
- Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
- Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
- Any medical condition determined by their physician to be a contraindication for physical exercise
- Taking opioid pain medication
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Boston Chilldren's Hospital
Boston, Massachusetts, 02116
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Riley Children's Hospital-University of Indiana
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.
Read the detailed description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluated whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.
- Conditions
- Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases
- Being tested
- Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy, Graded Aerobic Exercise
- Keywords
- juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training, neuromuscular exercise, graded aerobic exercise
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia Integrative Training for TeensBehavioural
Also called FIT Teens
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
Cognitive Behavioral TherapyBehavioural
Also called CBT, coping skills
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
Graded Aerobic ExerciseBehavioural
Also called GAE
This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Integrative Training for Teens | Experimental | Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance. Receives: Behavioral: Fibromyalgia Integrative Training for Teens |
| Cognitive Behavioral Therapy | Active comparator | Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements. Receives: Behavioral: Cognitive Behavioral Therapy |
| Graded Aerobic Exercise | Active comparator | Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks. Receives: Behavioral: Graded Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Inventory
Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs.
The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).
Measured: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Secondary outcomes (1)
Pain Intenstiy
Pain intensity was measured using the Visual Analog Scale (VAS), which is a validated measure of pain intensity in children and adolescents. Participants were shown a line with the written anchors of "no pain" and "pain as bad as I can imagine" on either end.
The line represents a 0-10 scale, where higher scores are representative of higher pain intensity with a score of 4-6 indicating at least moderate pain levels and a score of 7-10 indicating severe pain levels.
This measure was completed daily for one week and scores averaged over that time. For this secondary outcome, data from this measure were used to compare baseline response to 3 month follow up to examine whether a reduction in pain intensity occurred.
Measured: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start2 Jan 2018
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Model description
- Non-pharmacologic trial comparing behavioral and exercise-based treatments
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Susmita Kashikar-Zuck, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268421
- Sponsor's protocol ID
- CIN001-FIT Teens
- Other IDs
- R01AR070474
- Acronym
- FIT Teens
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2017
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kashikar-Zuck S, Briggs MS, Bout-Tabaku S, Connelly M, Daffin M, Guite J, Ittenbach R, Logan DE, Lynch-Jordan AM, Myer GD, Ounpuu S, Peugh J, Schikler K, Sugimoto D, Stinson JN, Ting TV, Thomas S, Williams SE, Zempsky W; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol. Contemp Clin Trials. 2021 Apr;103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20.
PubMed 33618033Kashikar-Zuck S, Barnett KA, Williams SE, Pfeiffer M, Thomas S, Beasley K, Chamberlin LA, Mundo K, Ittenbach RF, Peugh J, Gibler RC, Lynch-Jordan A, Ting TV, Gadd B, Taylor J, Goldstein-Leever A, Connelly M, Logan DE, Williams A, Wakefield EO, Myer GD; FIT Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022 Nov 29;30:101039. doi: 10.1016/j.conctc.2022.101039. eCollection 2022 Dec.
PubMed 36467389Kashikar-Zuck S, Thomas S, Bonnette S, Gibler RC, DiCesare C, Schille A, Hulburt T, Briggs MS, Ounpuu S, Myer GD; FIT Teens Clinical Trial Study Group. Comparison of Pain Characteristics, Strength, and Movement Patterns in Adolescents With Juvenile Fibromyalgia and High Versus Low Fear of Movement. J Pain. 2024 Sep;25(9):104586. doi: 10.1016/j.jpain.2024.104586. Epub 2024 May 31.
PubMed 38823603Lynch-Jordan AM, Connelly M, Guite JW, King C, Goldstein-Leever A, Logan DE, Nelson S, Stinson JN, Ting TV, Wakefield EO, Williams AE, Williams SE, Kashikar-Zuck S; Fibromyalgia Integrative Training for Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance Pain Workgroup Investigators. Clinical Characterization of Juvenile Fibromyalgia in a Multicenter Cohort of Adolescents Enrolled in a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1795-1803. doi: 10.1002/acr.25077. Epub 2023 Feb 16.
PubMed 36537193
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia
- ClinicalTrials.gov ID
- NCT03268421
- Acronym / sponsor ID
- FIT Teens / CIN001-FIT Teens
- Conditions
- Fibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal Disease, Rheumatic Diseases
- Keywords
- juvenile fibromyalgia, pain in children, musculoskeletal pain, cognitive behavioral therapy, coping skills training, neuromuscular exercise, graded aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.
Detailed description
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluated whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Non-pharmacologic trial comparing behavioral and exercise-based treatments
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Integrative Training for Teens | Experimental | Behavioral: Fibromyalgia Integrative Training for TeensFibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements. |
| Graded Aerobic Exercise | Active comparator | Behavioral: Graded Aerobic ExerciseGraded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
- Functional Disability Score ≥ 13, indicating at least moderate disability
- Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale
- Stable medications prior to enrollment
Key exclusion criteria (4 listed)
- Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
- Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
- Any medical condition determined by their physician to be a contraindication for physical exercise
- Taking opioid pain medication
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 |
|---|---|---|
| Fibromyalgia Integrative Training for TeensAlso: FIT TeensThis intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. | Behavioural | Fibromyalgia Integrative Training for Teens |
| Cognitive Behavioral TherapyAlso: CBT, coping skillsThis intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. | Behavioural | Cognitive Behavioral Therapy |
| Graded Aerobic ExerciseAlso: GAEThis intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols. | Behavioural | Graded Aerobic Exercise |
Primary outcome
Functional Disability Inventory
Time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).
1 secondary outcome
Pain Intenstiy
Time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33618033Kashikar-Zuck S, Briggs MS, Bout-Tabaku S, Connelly M, Daffin M, Guite J, Ittenbach R, Logan DE, Lynch-Jordan AM, Myer GD, Ounpuu S, Peugh J, Schikler K, Sugimoto D, Stinson JN, Ting TV, Thomas S, Williams SE, Zempsky W; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol. Contemp Clin Trials. 2021 Apr;103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20.
- Background: PubMed 36467389Kashikar-Zuck S, Barnett KA, Williams SE, Pfeiffer M, Thomas S, Beasley K, Chamberlin LA, Mundo K, Ittenbach RF, Peugh J, Gibler RC, Lynch-Jordan A, Ting TV, Gadd B, Taylor J, Goldstein-Leever A, Connelly M, Logan DE, Williams A, Wakefield EO, Myer GD; FIT Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022 Nov 29;30:101039. doi: 10.1016/j.conctc.2022.101039. eCollection 2022 Dec.
- Derived from this study: PubMed 38823603Kashikar-Zuck S, Thomas S, Bonnette S, Gibler RC, DiCesare C, Schille A, Hulburt T, Briggs MS, Ounpuu S, Myer GD; FIT Teens Clinical Trial Study Group. Comparison of Pain Characteristics, Strength, and Movement Patterns in Adolescents With Juvenile Fibromyalgia and High Versus Low Fear of Movement. J Pain. 2024 Sep;25(9):104586. doi: 10.1016/j.jpain.2024.104586. Epub 2024 May 31.
- Derived from this study: PubMed 36537193Lynch-Jordan AM, Connelly M, Guite JW, King C, Goldstein-Leever A, Logan DE, Nelson S, Stinson JN, Ting TV, Wakefield EO, Williams AE, Williams SE, Kashikar-Zuck S; Fibromyalgia Integrative Training for Teens Clinical Trial Study Group and the Childhood Arthritis and Rheumatology Research Alliance Pain Workgroup Investigators. Clinical Characterization of Juvenile Fibromyalgia in a Multicenter Cohort of Adolescents Enrolled in a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1795-1803. doi: 10.1002/acr.25077. Epub 2023 Feb 16.
- 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.
Susmita Kashikar-Zuck, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy and Graded Aerobic Exercise in people with Fibromyalgia and Myofascial Pain Syndrome, run by Children's Hospital Medical Center, Cincinnati at 7 sites in 2 countries.
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 4 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Disability Inventory (time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up). 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 NCT03268421, which also lists 4 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 14 Feb 2025.