Low Back PainNCT02883634
Specific or Non-Specific Manipulation for Patients With Back Pain
A study testing Specific manipulation and Non-specific manipulation in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Specific manipulation and Non-specific manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2017to 23 Nov 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low back pain duration from 3 to 24 months.
Who cannot join
- Patients with a pain duration lower than 3 months and higher than 24 months.
- Patients with nerve root compromise or with serious spinal pathology,
- Pregnant patients,
- Previous back surgery
- Patients with any contra-indication to spinal manipulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
Read the detailed description
To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).
- Conditions
- Low Back Pain
- Being tested
- Specific manipulation, Non-specific manipulation
- Keywords
- Back pain, spinal manipulation
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific manipulationOther
Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.
Non-specific manipulationOther
Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| specific manipulation | Experimental | Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination. Receives: Other: Specific manipulation |
| non-specific manipulation | Experimental | Participants allocated to group "non-specific manipulation" will have their upper thoracic spine manipulated (also known as "global manipulation") regardless of the previous clinical examination. Receives: Other: Non-specific manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be measured using a 0-10 numerical rating scale
Measured: 4 weeks
Secondary outcomes (4)
Pain Intensity
Pain intensity will be measured using a 0-10 numerical rating scale
Measured: 3 and 6 months after randomization
Disability
Disability will be measured by the 0-24 Roland Morris Disability Questionnaire
Measured: 4 weeks, 3 and 6 months after randomization
Global Impression of Recovery
Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale
Measured: 4 weeks, 3 and 6 months after randomization
Pressure Pain Threshold
Pressure Pain Threshold will be measure by a digital pressure algomoter
Measured: 4 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start3 Apr 2017
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronaldo Fernando de Oliveira, Universidade Cidade de Sao Paulo
- Investigators
- Leonardo Costa, PT, PhD, Study chair, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883634
- Sponsor's protocol ID
- UNICID10
- Status last verified
- Sep 2019
- First submitted
- 25 Aug 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are happy to share our data with researchers that would like to use it on an IPD.
Publications
de Oliveira RF, Costa LOP, Nascimento LP, Rissato LL. Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial. J Physiother. 2020 Jul;66(3):174-179. doi: 10.1016/j.jphys.2020.06.007. Epub 2020 Jul 10.
PubMed 32660919
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02883634
- Acronym / sponsor ID
- UNICID10
- Conditions
- Low Back Pain
- Keywords
- Back pain, spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 30 Aug 2016 (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.
We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
Detailed description
To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| specific manipulation | Experimental | Other: Specific manipulationParticipants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination. |
| non-specific manipulation | Experimental | Other: Non-specific manipulationParticipants allocated to group "non-specific manipulation" will have their upper thoracic spine manipulated (also known as "global manipulation") regardless of the previous clinical examination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with low back pain duration from 3 to 24 months.
Key exclusion criteria (5 listed)
- Patients with a pain duration lower than 3 months and higher than 24 months.
- Patients with nerve root compromise or with serious spinal pathology,
- Pregnant patients,
- Previous back surgery
- Patients with any contra-indication to spinal manipulation.
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 |
|---|---|---|
| Specific manipulationPatients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation. | Other | specific manipulation |
| Non-specific manipulationPatients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation. | Other | non-specific manipulation |
Primary outcome
Pain Intensity
Time frame: 4 weeks
Pain intensity will be measured using a 0-10 numerical rating scale
4 secondary outcomes
Pain Intensity
Time frame: 3 and 6 months after randomization
Disability
Time frame: 4 weeks, 3 and 6 months after randomization
Global Impression of Recovery
Time frame: 4 weeks, 3 and 6 months after randomization
Pressure Pain Threshold
Time frame: 4 weeks after randomization
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 26 Sep 2019.
- Derived from this study: PubMed 32660919de Oliveira RF, Costa LOP, Nascimento LP, Rissato LL. Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial. J Physiother. 2020 Jul;66(3):174-179. doi: 10.1016/j.jphys.2020.06.007. Epub 2020 Jul 10.
- Individual participant dataSharing planned: Undecided. We are happy to share our data with researchers that would like to use it on an IPD.
Related trials for Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
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.
Leonardo Costa, PT, PhD study chair
Universidade Cidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific manipulation and Non-specific manipulation in people with Low Back Pain, run by Universidade Cidade de 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 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 26 Sep 2019. 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?
Pain Intensity (time frame: 4 weeks). 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 NCT02883634, 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 26 Sep 2019.