Exercise TrainingNCT04887987
Effects of Different Exercise Programs Plus Photobiomodulation on Non-specific Low-back Pain.
A study testing Pilates training + active PBMT and Multicomponent training + active PBMT in people with Exercise Training and Photobiomodulation Therapy, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
The present project aims to examine the effects of different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, perceived disability, kinesiophobia, and pain-related fear of movement in patients with chronic non-specific low back pain… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Photobiomodulation Therapy, Low Back Pain
- What is being tested?
- Pilates training + active PBMT and Multicomponent training + active PBMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2022to 30 Nov 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 years
- Self-report of recurrent (≥ 3 x/week) or continuous episodes of nonspecific low back pain for at least 3 months, comprising the lumbar region between L1-L5
Who cannot join
- To present a history of musculoskeletal disorders that could affect muscle function
- To make use of medicines that could affect muscle function.
- To present low back pain of specific etiology, such as: tumor, herniated disc, facet syndrome, canal stenosis, among others.
- To have used ergogenic supplements and anabolic steroids for at least six months before study
- To present severe skin diseases in the lumbar region, such as: erysipelas, eczema, dermatitis, psoriasis and urticaria
- To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Two Exercise Programs (Pilates and Multicomponent) Combined With Photobiomodulation Therapy on Pain Intensity, Postural Balance, Perceived Disability, Kinesiophobia, and Pain-related Fear of Movement in Patients With Chronic Non-specific Low Back Pain (CNLBP): a Randomized, Placebo-controlled Clinical Trial.
The present project aims to examine the effects of different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, perceived disability, kinesiophobia, and pain-related fear of movement in patients with chronic non-specific low back pain (CNLBP). It was hypothesized that the exercise programs plus active PBMT would outperform the exercise program alone (sham PBMT) in improving postural balance, and decreasing pain intensity, perceived disability, kinesiophobia, and pain-related fear of movement in patients with CNLBP.
Read the detailed description
The purpose of this study will be to investigate the effects of two different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, and psychological aspects in individuals with chronic non-specific low back pain (CNLBP). Participants will be randomized into four groups (n = 20 per group): Pilates exercise program + active PBMT (PIL+PBMT), Pilates exercise program + sham PBMT (PIL+SHAM), multicomponent exercise program + active PBMT (EX+PBMT) and multicomponent exercise program + sham PBMT (EX+SHAM). The PIL+PBMT and PIL+SHAM groups will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive their respective PBMT (active or sham) on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. The EX+PBMT and EX+SHAM groups will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive their respective PBMT (active or sham) on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). The sham PBMT will be applied with the device turned off. Participants and the two physiotherapists responsible for the assessments and exercise sessions will be blinded to PBMT treatments. The following variables will be assessed at pre and post-training: anthropometric measures, peak pain intensity, postural balance, perceived disability (Oswestry Disability Index [ODI], Roland Morris disability questionnaire [RMDQ]), kinesiophobia (Tampa Scale of kinesiophobia [TSK]), and Pain-related fear of movement (Pain Catastrophizing Scale [PCS]), and Fear Avoidance Beliefs Questionnaire [FABQ]. Statistical analyses were performed using IBM SPSS Statistics for Windows (version 24.0; IBM Corp., Armonk, New York). The baseline characteristics will be analyzed using an unpaired Student's t test. Nonparametric tests will be used due to ordinal data of the dependent variables (pain intensity, ODI, RMDQ, TSK, PCS, and FABQ-Phys). The Wilcoxon signed-rank test will be used to assess within-group changes (from pre-intervention to postintervention), while the Mann-Whitney U test will be used to compare the between-groups changes (relative difference, ∆% = [post - pre]/pre*100) for all dependents variables. The significance level will set at p < 0.05. The effect size (r) for within- and between-groups changes will be considered trivial (0.0-<0.1), small (0.1-<0.3), moderate (0.3-<0.5), and large (≥0.5).
- Conditions
- Exercise Training, Photobiomodulation Therapy, Low Back Pain
- Being tested
- Pilates training + active PBMT, Pilates training + sham PBMT, Multicomponent training + active PBMT, Multicomponent training + sham PBMT
- Keywords
- Exercise training, Photobiomodulation therapy, Light-emitting diodes, Low back pain, Perceived disability, kinesiophobia, Pain-related fear of moviment
- Medical subject headings
- Low Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates training + active PBMTOther
Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout.
Pilates training + sham PBMTOther
Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout.
Multicomponent training + active PBMTOther
Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region imediately before each workout.
Multicomponent training + sham PBMTOther
Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region imediately before each workout.
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise program + active PBMT (PIL+PBMT) | Experimental | Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. Receives: Other: Pilates training + active PBMT |
| Pilates exercise program + sham PBMT (PIL+SHAM) | Sham comparator | Participants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. Receives: Other: Pilates training + sham PBMT |
| Multicomponent exercise program + active PBMT (EX+PBMT) | Experimental | Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). Receives: Other: Multicomponent training + active PBMT |
| Multicomponent exercise program + sham PBMT (EX+SHAM) | Sham comparator | Participants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). Receives: Other: Multicomponent training + sham PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak pain intensity
Pain severity will be determine using a 10-point numerical rating scale (NRS), with extremities designated as 0 (no pain) to 10 (unbearable pain). Participants will be instructed to draw a vertical line at a scale point that best matched their level of pain throughout the day. Pain intensity was recorded at night (between 7 and 8 p.m.) for the first 3 days before the intervention (basal) and the last 3 days after the intervention.
Measured: Baseline and after 8 weeks
Tampa Scale of kinesiophobia (TSK)
The TSK is a 17-item self-report questionnaire designed to assess fear of movement, fear of physical activity, and fear avoidance beliefs in patients with chronic LBP [1, 2]. Each item has a 4-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), with individual scores for items 4, 8, 12, and 16 reversed. The total score is the sum of all items ranging from 17 to 68 points, with higher scores indicating a higher level of kinesiophobia [2].
Measured: Baseline and after 8 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ-Phys)
The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity (FABQ-Phys) and work may affect and contribute to their low back pain and resulting disability. The FABQ-Phys has four items with a 6-point Likert scale on each, ranging from 0 (strongly disagree) to 6 (strongly agree) [3, 4]. The total score is the sum of all items ranging from 0 to 24, with a higher score indicating a higher level of fear and avoidance behavior associated with beliefs about how physical activity affects LBP.
Measured: Baseline and after 8 weeks
Pain Catastrophizing Scale (PCS)
PCS is a instrument used for measuring catastrophic thinking related to pain. The PCS is a 13-item scale that measures the effect of LBP on rumination, amplification of pain sensations, and feelings of helplessness to control pain [5]. Each item has a 4-point scale ranging from 0 (not at all) to 4 (all the time), on which the participant indicates their level of thoughts and feelings while they are in pain. The total score is the sum of all items on a scale of 0-52 points, with higher scores indicating a higher level of pain catastrophizing [5].
Measured: Baseline and after 8 weeks
Oswestry Disability Index (ODI)
The ODI is used to assess self-reports of disability caused by LBP [6, 7]. The ODI is made up of 10 sections scored from 0 to 5 points, with the total score ranging from 0 to 50 points [6]. A higher score indicates a higher level of disability [6, 8].
Measured: Baseline and after 8 weeks
Roland Morris Disability Questionnaire (RMDQ)
RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain. The RMDQ consists of 24 items with scores ranging from 0 to 24 points [6]. A higher score indicates a higher level of disability [6, 8].
Measured: Baseline and after 8 weeks
Secondary outcomes (1)
Postural balance
Postural balance will be assess using a force platform. All participants will performed three attempts at static unipedal standing postures (right and left legs) for 30 s each, with a 1 min rest interval in between. The mean of three attempts will be used for analysis. Participants will be instructed to stand on a platform (barefoot), arms parallel to the trunk, eyes open, and look at a target (circle) on a wall 2.5 m away. Stabilographic analysis of the COP will be used to derive the following balance parameters: area of the COP (A-COP), velocity anteroposterior (Vel AP), and velocity mediolateral (Vel ML).
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreo Fernando Aguiar, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887987
- Sponsor's protocol ID
- Photobiomodulation project
- Status last verified
- Aug 2024
- First submitted
- 13 May 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hudes K. The Tampa Scale of Kinesiophobia and neck pain, disability and range of motion: a narrative review of the literature. J Can Chiropr Assoc. 2011 Sep;55(3):222-32.
PubMed 21886284Lundberg M, Styf J, Jansson B. On what patients does the Tampa Scale for Kinesiophobia fit? Physiother Theory Pract. 2009 Oct;25(7):495-506. doi: 10.3109/09593980802662160.
PubMed 19925172Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
PubMed 8455963Jacob T, Baras M, Zeev A, Epstein L. Low back pain: reliability of a set of pain measurement tools. Arch Phys Med Rehabil. 2001 Jun;82(6):735-42. doi: 10.1053/apmr.2001.22623.
PubMed 11387576Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
PubMed 11124727
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Exercise Programs (Pilates and Multicomponent) Combined With Photobiomodulation Therapy on Pain Intensity, Postural Balance, Perceived Disability, Kinesiophobia, and Pain-related Fear of Movement in Patients With Chronic Non-specific Low Back Pain (CNLBP): a Randomized, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04887987
- Acronym / sponsor ID
- Photobiomodulation project
- Conditions
- Exercise Training, Photobiomodulation Therapy, Low Back Pain
- Keywords
- Exercise training, Photobiomodulation therapy, Light-emitting diodes, Low back pain, Perceived disability, kinesiophobia, Pain-related fear of moviment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 May 2021 (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 present project aims to examine the effects of different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, perceived disability, kinesiophobia, and pain-related fear of movement in patients with chronic non-specific low back pain (CNLBP). It was hypothesized that the exercise programs plus active PBMT would outperform the exercise program alone (sham PBMT) in improving postural balance, and decreasing pain intensity, perceived disability, kinesiophobia, and pain-related fear of movement in patients with CNLBP.
Detailed description
The purpose of this study will be to investigate the effects of two different exercise programs (Pilates and multicomponent) combined with photobiomodulation therapy (PBMT) on pain intensity, postural balance, and psychological aspects in individuals with chronic non-specific low back pain (CNLBP). Participants will be randomized into four groups (n = 20 per group): Pilates exercise program + active PBMT (PIL+PBMT), Pilates exercise program + sham PBMT (PIL+SHAM), multicomponent exercise program + active PBMT (EX+PBMT) and multicomponent exercise program + sham PBMT (EX+SHAM). The PIL+PBMT and PIL+SHAM groups will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive their respective PBMT (active or sham) on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. The EX+PBMT and EX+SHAM groups will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive their respective PBMT (active or sham) on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). The sham PBMT will be applied with the device turned off. Participants and the two physiotherapists responsible for the assessments and exercise sessions will be blinded to PBMT treatments. The following variables will be assessed at pre and post-training: anthropometric measures, peak pain intensity, postural balance, perceived disability (Oswestry Disability Index [ODI], Roland Morris disability questionnaire [RMDQ]), kinesiophobia (Tampa Scale of kinesiophobia [TSK]), and Pain-related fear of movement (Pain Catastrophizing Scale [PCS]), and Fear Avoidance Beliefs Questionnaire [FABQ]. Statistical analyses were performed using IBM SPSS Statistics for Windows (version 24.0; IBM Corp., Armonk, New York). The baseline characteristics will be analyzed using an unpaired Student's t test. Nonparametric tests will be used due to ordinal data of the dependent variables (pain intensity, ODI, RMDQ, TSK, PCS, and FABQ-Phys). The Wilcoxon signed-rank test will be used to assess within-group changes (from pre-intervention to postintervention), while the Mann-Whitney U test will be used to compare the between-groups changes (relative difference, ∆% = [post - pre]/pre*100) for all dependents variables. The significance level will set at p < 0.05. The effect size (r) for within- and between-groups changes will be considered trivial (0.0-<0.1), small (0.1-<0.3), moderate (0.3-<0.5), and large (≥0.5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise program + active PBMT (PIL+PBMT) | Experimental | Other: Pilates training + active PBMTParticipants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. |
| Pilates exercise program + sham PBMT (PIL+SHAM) | Sham comparator | Other: Pilates training + sham PBMTParticipants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) 10 min before and after exercise sessions (totaling 20 min), through a device containing 264 LEDs (132 red and 132 infrared. |
| Multicomponent exercise program + active PBMT (EX+PBMT) | Experimental | Other: Multicomponent training + active PBMTParticipants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). |
| Multicomponent exercise program + sham PBMT (EX+SHAM) | Sham comparator | Other: Multicomponent training + sham PBMTParticipants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region (between L1 and L5) imediately before each workout, through a device containing 200 LEDs (100 red and 100 infrared). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18-75 years
- Self-report of recurrent (≥ 3 x/week) or continuous episodes of nonspecific low back pain for at least 3 months, comprising the lumbar region between L1-L5
Key exclusion criteria (6 listed)
- To present a history of musculoskeletal disorders that could affect muscle function
- To make use of medicines that could affect muscle function.
- To present low back pain of specific etiology, such as: tumor, herniated disc, facet syndrome, canal stenosis, among others.
- To have used ergogenic supplements and anabolic steroids for at least six months before study
- To present severe skin diseases in the lumbar region, such as: erysipelas, eczema, dermatitis, psoriasis and urticaria
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 |
|---|---|---|
| Pilates training + active PBMTParticipants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive active PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout. | Other | Pilates exercise program + active PBMT (PIL+PBMT) |
| Pilates training + sham PBMTParticipants will be submitted to a supervised 8-wk mat Pilates exercise program (2 x/week) and will receive sham PBMT on the lumbar region 10 min before and after (totaling 20 min) each workout. | Other | Pilates exercise program + sham PBMT (PIL+SHAM) |
| Multicomponent training + active PBMTParticipants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive active PBMT on the lumbar region imediately before each workout. | Other | Multicomponent exercise program + active PBMT (EX+PBMT) |
| Multicomponent training + sham PBMTParticipants will be submitted to a supervised 8-wk multicomponent exercise program (3 x/week) and will receive sham PBMT on the lumbar region imediately before each workout. | Other | Multicomponent exercise program + sham PBMT (EX+SHAM) |
Primary outcome
Peak pain intensity
Time frame: Baseline and after 8 weeks
Pain severity will be determine using a 10-point numerical rating scale (NRS), with extremities designated as 0 (no pain) to 10 (unbearable pain). Participants will be instructed to draw a vertical line at a scale point that best matched their level of pain throughout the day. Pain intensity was recorded at night (between 7 and 8 p.m.) for the first 3 days before the intervention (basal) and the last 3 days after the intervention.
Tampa Scale of kinesiophobia (TSK)
Time frame: Baseline and after 8 weeks
The TSK is a 17-item self-report questionnaire designed to assess fear of movement, fear of physical activity, and fear avoidance beliefs in patients with chronic LBP [1, 2]. Each item has a 4-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), with individual scores for items 4, 8, 12, and 16 reversed. The total score is the sum of all items ranging from 17 to 68 points, with higher scores indicating a higher level of kinesiophobia [2].
Fear-Avoidance Beliefs Questionnaire (FABQ-Phys)
Time frame: Baseline and after 8 weeks
The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity (FABQ-Phys) and work may affect and contribute to their low back pain and resulting disability. The FABQ-Phys has four items with a 6-point Likert scale on each, ranging from 0 (strongly disagree) to 6 (strongly agree) [3, 4]. The total score is the sum of all items ranging from 0 to 24, with a higher score indicating a higher level of fear and avoidance behavior associated with beliefs about how physical activity affects LBP.
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and after 8 weeks
PCS is a instrument used for measuring catastrophic thinking related to pain. The PCS is a 13-item scale that measures the effect of LBP on rumination, amplification of pain sensations, and feelings of helplessness to control pain [5]. Each item has a 4-point scale ranging from 0 (not at all) to 4 (all the time), on which the participant indicates their level of thoughts and feelings while they are in pain. The total score is the sum of all items on a scale of 0-52 points, with higher scores indicating a higher level of pain catastrophizing [5].
Oswestry Disability Index (ODI)
Time frame: Baseline and after 8 weeks
The ODI is used to assess self-reports of disability caused by LBP [6, 7]. The ODI is made up of 10 sections scored from 0 to 5 points, with the total score ranging from 0 to 50 points [6]. A higher score indicates a higher level of disability [6, 8].
Roland Morris Disability Questionnaire (RMDQ)
Time frame: Baseline and after 8 weeks
RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain. The RMDQ consists of 24 items with scores ranging from 0 to 24 points [6]. A higher score indicates a higher level of disability [6, 8].
1 secondary outcome
Postural balance
Time frame: Baseline and after 8 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 12 Aug 2024.
- Results publication: PubMed 21886284Hudes K. The Tampa Scale of Kinesiophobia and neck pain, disability and range of motion: a narrative review of the literature. J Can Chiropr Assoc. 2011 Sep;55(3):222-32.
- Results publication: PubMed 19925172Lundberg M, Styf J, Jansson B. On what patients does the Tampa Scale for Kinesiophobia fit? Physiother Theory Pract. 2009 Oct;25(7):495-506. doi: 10.3109/09593980802662160.
- Results publication: PubMed 8455963Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Results publication: PubMed 11387576Jacob T, Baras M, Zeev A, Epstein L. Low back pain: reliability of a set of pain measurement tools. Arch Phys Med Rehabil. 2001 Jun;82(6):735-42. doi: 10.1053/apmr.2001.22623.
- Results publication: PubMed 11124727Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
- 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 Pilates training + active PBMT and Multicomponent training + active PBMT in people with Exercise Training and Photobiomodulation Therapy, run by Universidade Norte do Paraná at 1 site in Brazil.
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 6 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 12 Aug 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 Brazil. 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?
Peak pain intensity (time frame: Baseline and after 8 weeks). The study lists 6 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 NCT04887987, which also lists 5 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 12 Aug 2024.