An interventional study of Cognitive Functional Therapy and Core Training Exercise and Manual Therapy in Low Back Pain, Back Pain and Pain, sponsored by Centro Universitário Augusto Motta. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Centro Universitário Augusto Motta · Not applicable, Interventional, and Treatment
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Among 125 studies in Low Back Pain with a site in Brazil — 10 open to participants now, 12 under way, none of them phase 3. Low Back Pain · Brazil.
Among the 125 studies in Low Back Pain with a site in Brazil, this one is the 20th largest by enrollment of the 122 interventional ones that give a count, is one of 19 that started in 2017, is one of 101 with no phase, and was the 77th registered.
2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.
Browse Low Back Pain studies →10 of the 125 studies in Low Back Pain with a site in Brazil are open now. Recruiting first, the newest first:
Federal University of Bahia · Sites in Brazil
Ages 18–55
Gabriela Souza de Vasconcelos · Sites in Brazil
Ages 18–59
University of Nove de Julho · Sites in Brazil
Ages 18–70
University of Nove de Julho · Sites in Brazil
Ages 18–65
Centro Universitário Augusto Motta · Sites in Brazil
Ages 65+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 332 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 210 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 12 · Phase 4 4
First in 2002; this study’s year is marked. 19 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 148 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Median enrollment 66 across the 122 interventional studies, 100 across the 3 observational. Of the 75 that completed or were terminated, 5 (7%) have results posted.
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8 of 125 have an industry lead sponsor. The 10 most frequent:
Centro Universitário Augusto Motta is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
Centro Universitário Augusto Motta has 6 studies filed under Low Back Pain — fewer than ten, so there is no comparison to draw.
4 of the studies in Low Back Pain with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05459376Universidade Federal do Rio Grande do NorteEffect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain | 2027-01-01 |
| NCT07639216Centro Universitário Augusto MottaNeuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain | 2027-07 |
| NCT05480982Centro Universitário Augusto MottaCognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain | 2027-07 |
| NCT06651099University of BrasiliaTrial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain | 2027-07-30 |
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Among the 125 studies in Low Back Pain with a site in Brazil, from their registry updates:
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There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. As it is, it is important to carry out more studies involving CFT compared to other interventions already used in clinical practice and to correct these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
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Exclusion Criteria:
Cognitive Functional Therapy (CFT) is a behavioral intervention that addresses multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, educating them about pain mechanisms, increasing mental strength, and control of their body. This is done with functional tasks performed by individuals training them to reduce excessive muscle activity in the trunk and generate behavioral changes related to pain, from postures and provocative movements.
Behavioral: Cognitive Functional Therapy
The active comparator will be the combination of Core Training Exercise and Manual Therapy (CORE-MT).
Other: Core Training Exercise and Manual Therapy
There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015): 1. The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability. 2. Specific Functional training is designed to normalize maladaptive or provocative movement and posture. 3. Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting) 4. Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies
According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT.
Pain intensity
It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days
Time frame: 8 weeks
Disability associated to low back pain
It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
Time frame: 8 weeks
Global impression of recovery
It will be evaluated based on the Global Perceived Effect Scale (GPES) which is an 11-point scale ranging from -5 ('vastly worse'), through 0 (no change) to +5 (completely recovered).
Time frame: 8 weeks, 6 and 12 months after randomization
Pain intensity
It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days.
Time frame: 6 and 12 months after randomization
Disability associated to low back pain
It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
Time frame: 6 and 12 months after randomization
Patient Satisfaction (mediator of outcome)
This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied
Time frame: 8 weeks, 6 and 12 months after randomization
Catastrophization (mediator of outcome)
It will be evaluated by the question "When I feel pain, it's terrible and I feel it's never going to get any better."with the response options ranging from "Never do that" = 0 to "Always do that" = 10.
Time frame: 8 weeks, 6 and 12 months after randomization
Depression (mediator of outcome)
It will be evaluated by the question "During the past month have you often been bothered by feeling down, depressed or hopeless?" with the response options ranging from "Never" = 0 to "All the time" = 10.
Time frame: 8 weeks, 6 and 12 months months after randomization
Fear of movement (mediator of outcome)
It will be assessed by the question "Physical activity might harm my back" and the response options will range from 0 ("completely disagree") to 10 ("completely agree).
Time frame: 8 weeks, 6 and 12 months months after randomization
Stress (mediator of outcome)
It will be evaluated by the question "Do you feel stressed? and the response options will range from 0 ("completely disagree") to 10 ("completely agree)
Time frame: 8 weeks, 6 and 12 months months after randomization
Sleep (mediator of outcome)
It will be evaluated by the question "Did you have sleep problems last month?" based on Subjective Health Complaints Inventory19. The response options will be "Not at all"=0, "A little"=1, "Some"=2, and "Serious"=3
Time frame: 8 weeks, 6 and 12 months months after randomization
Ran from Sep 2017 to primary completion in Jun 2020, 33 months.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's 33 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Centro Universitário Augusto Motta