Upper Limb; Injury, Superficial, MultipleNCT04047056
Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders
A study testing Labor Kinesiotherapy in people with Upper Limb; Injury, Superficial, Multiple, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
ABSTRACT Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb; Injury, Superficial, Multiple
- What is being tested?
- Labor Kinesiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2021to 25 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.
Who cannot join
- Workers presenting:
- Pregnancy;
- Congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria);
- Severe cervical spine disorders, postoperative conditions in the neck or upper limb region;
- Uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise;
- Workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises.
- Workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
ABSTRACT
Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p <0.05 significance.
- Being tested
- Labor Kinesiotherapy
- Keywords
- physiotherapy, prevention, pain, upper limb, exercises, musculoskeletal disorders
- Medical subject headings
- Wounds and Injuries, Pain, Motor Activity, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor KinesiotherapyOther
The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds.
Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic Guidelines Manual | Placebo comparator | A manual of ergonomic occupational and daily living guidelines will be given to both control and labor kinesiotherapy groups, which is the only approach for the control group initially. Receives: Other: Labor Kinesiotherapy |
| Labor Kinesiotherapy in group | Active comparator | The intervention will be performed by a physical therapist, which will consist of preparatory labor kinesiotherapy, which aims to prepare the workers' osteo-articular system for the beginning of the work activity, acting more specifically on those muscle groups that will be most required during the journey which will be identified in the evaluation. Labor kinesiotherapy will be performed in the workplace before the workday and will last 20 minutes, 3 times a week, for 12 weeks. Receives: Other: Labor Kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale - NPS
Difference in numerical pain scale in the 3 evaluations. The numerical pain scale score ranges from 0 to 10, with values closer to 10 indicating worse pain.
Measured: 12 weeks.
shoulder abduction Torque peak in the Isokinetic Dynamometer
Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.
Measured: 12 weeks.
Secondary outcomes (2)
Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)
Difference in DASH questionnaire scores in 3 evaluations. The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.
Measured: 12 weeks.
Patient Specific Functional Scale (PSFS)
Difference in PSFS questionnaire scores in 3 evaluations. The PSFS allows patients to report on their functional status at baseline and at a follow-up session, to determine if a meaningful change in functional status has occurred.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jun 2021
- Primary completion20 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb; Injury, Superficial, MultipleStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marisa de Cassia Registro Fonseca, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047056
- Sponsor's protocol ID
- FMRPUSP3
- Status last verified
- Dec 2024
- First submitted
- 31 Jul 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva NC, Ricci FPFM, de Castro VR, de Lima ACR, do Carmo Lopes ER, de Salvo Mauad LD, Kawano Suzuki KA, de Oliveira Medeiros ME, de Santana JS, Rocha FLR, de Cassia Registro Fonseca M. Effects of workplace upper extremity resistance exercises on function and symptoms of workers at a tertiary hospital: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Feb 5;23(1):119. doi: 10.1186/s12891-022-05059-5.
PubMed 35123476
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
- ClinicalTrials.gov ID
- NCT04047056
- Acronym / sponsor ID
- FMRPUSP3
- Keywords
- physiotherapy, prevention, pain, upper limb, exercises, musculoskeletal disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 6 Aug 2019 (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.
ABSTRACT
Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p <0.05 significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergonomic Guidelines Manual | Placebo comparator | Other: Labor KinesiotherapyA manual of ergonomic occupational and daily living guidelines will be given to both control and labor kinesiotherapy groups, which is the only approach for the control group initially. |
| Labor Kinesiotherapy in group | Active comparator | Other: Labor KinesiotherapyThe intervention will be performed by a physical therapist, which will consist of preparatory labor kinesiotherapy, which aims to prepare the workers' osteo-articular system for the beginning of the work activity, acting more specifically on those muscle groups that will be most required during the journey which will be identified in the evaluation. Labor kinesiotherapy will be performed in the workplace before the workday and will last 20 minutes, 3 times a week, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.
Key exclusion criteria (7 listed)
- Workers presenting:
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 |
|---|---|---|
| Labor KinesiotherapyThe intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds. Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue. | Other | Ergonomic Guidelines Manual, Labor Kinesiotherapy in group |
Primary outcome
Numerical Pain Scale - NPS
Time frame: 12 weeks.
Difference in numerical pain scale in the 3 evaluations. The numerical pain scale score ranges from 0 to 10, with values closer to 10 indicating worse pain.
shoulder abduction Torque peak in the Isokinetic Dynamometer
Time frame: 12 weeks.
Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.
2 secondary outcomes
Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)
Time frame: 12 weeks.
Patient Specific Functional Scale (PSFS)
Time frame: 12 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 5 Dec 2024.
- Derived from this study: PubMed 35123476da Silva NC, Ricci FPFM, de Castro VR, de Lima ACR, do Carmo Lopes ER, de Salvo Mauad LD, Kawano Suzuki KA, de Oliveira Medeiros ME, de Santana JS, Rocha FLR, de Cassia Registro Fonseca M. Effects of workplace upper extremity resistance exercises on function and symptoms of workers at a tertiary hospital: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Feb 5;23(1):119. doi: 10.1186/s12891-022-05059-5.
- Individual participant dataSharing planned: No
Related trials for Upper Limb; Injury, Superficial, Multiple
Not yet recruitingObservational study
Upper Limb Functional Index
Upper Limb Function, Upper Limb Pain
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 Labor Kinesiotherapy in people with Upper Limb; Injury, Superficial, Multiple, run by University of Sao Paulo 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 1 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 5 Dec 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?
Numerical Pain Scale - NPS (time frame: 12 weeks.). The study lists 2 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 NCT04047056, which also lists 1 linked publication.
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 5 Dec 2024.