Chronic Low Back PainNCT01314157
Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
A study testing Isostretching in people with Chronic Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Isostretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2011to 30 Nov 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;
- Mechanical back pain that worsens with exertion and relieved by rest;
- Pain between 3 and 8 cm measured by analog pain scale.
Who cannot join
- Subjects who presented pain root
- Fibromyalgia
- Severe scoliosis with abnormal alignment of the spine (Cobb angle> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)
- Have changed or initiated physical activity in the last three months
- Body mass index greater than 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Isostretching Effects in Patients With Mechanical and Postural
Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.
Read the detailed description
Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p < .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Isostretching
- Keywords
- low back pain, pain, incapacity, life quality, rehabilitation
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsostretchingOther
Also called Strengthening and stretching exercise during expiration.
12 interventions (two times per week) for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy treatment technique | Experimental | Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with "technical isostretching" Receives: Other: Isostretching |
| Patients remained on the waiting list | No intervention | Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of isostretching effects in patients with chronic low back pain
Reviewed by analog pain scale. (VAS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study start1 Mar 2011
- Primary completion30 Nov 2011
- Study completion30 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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
- Model description
- Alocados de forma cega para o grupo de intervenção: 27 pacientes com diagnóstico de lombalgia crônica realizaram o Isostretching e uso de diclofenaco em caso de dor e grupo controle:27 pacientes com lombalgia crônica sem atividade física com uso apenas de diclofenaco em caso dedor Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego. Os pacientes foram instruídos nos dois grupos, pelo médico, a utilizar o diclofenaco de sódio 50mg, a cada oito horas de acordo com a dor.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Rosangela Alves Prado, Federal University of São Paulo
- Investigators
- Erika Rosângela A Prado, Specialist, Principal investigator, Universidade Estadual de Ciências da Saúde de Alagoas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314157
- Sponsor's protocol ID
- 1-Prado
- Status last verified
- Jul 2022
- First submitted
- 11 Mar 2011
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Isostretching Effects in Patients With Mechanical and Postural
- ClinicalTrials.gov ID
- NCT01314157
- Acronym / sponsor ID
- 1-Prado
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, pain, incapacity, life quality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 30 Nov 2011 (actual)
- Study completion
- 30 Nov 2011 (actual)
- First posted
- 14 Mar 2011 (estimated)
- 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.
Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.
Detailed description
Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p < .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Alocados de forma cega para o grupo de intervenção: 27 pacientes com diagnóstico de lombalgia crônica realizaram o Isostretching e uso de diclofenaco em caso de dor e grupo controle:27 pacientes com lombalgia crônica sem atividade física com uso apenas de diclofenaco em caso dedor Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego. Os pacientes foram instruídos nos dois grupos, pelo médico, a utilizar o diclofenaco de sódio 50mg, a cada oito horas de acordo com a dor.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy treatment technique | Experimental | Other: IsostretchingRandomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with "technical isostretching" |
| Patients remained on the waiting list | No intervention | –Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;
- Mechanical back pain that worsens with exertion and relieved by rest;
- Pain between 3 and 8 cm measured by analog pain scale.
Key exclusion criteria (5 listed)
- Subjects who presented pain root
- Fibromyalgia
- Severe scoliosis with abnormal alignment of the spine (Cobb angle> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)
- Have changed or initiated physical activity in the last three months
- Body mass index greater than 30 kg/m2
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 |
|---|---|---|
| IsostretchingAlso: Strengthening and stretching exercise during expiration.12 interventions (two times per week) for 45 minutes | Other | Physiotherapy treatment technique |
Primary outcome
Evaluation of isostretching effects in patients with chronic low back pain
Time frame: 1 month
Reviewed by analog pain scale. (VAS)
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 1 Aug 2022.
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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.
Erika Rosângela A Prado, Specialist principal investigator
Universidade Estadual de Ciências da Saúde de Alagoas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isostretching in people with Chronic Low Back Pain, run by Federal University of São 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 3 inclusion and 5 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 1 Aug 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 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. 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?
Evaluation of isostretching effects in patients with chronic low back pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022.