Low Back PainNCT03190187
Spinal Manipulation Effectiveness in Spinal Disorders
A study testing Spinal Manipulation in people with Low Back Pain and Cervical Pain, run by DAVID CRUZ DÍAZ at 1 site in Spain.
Trial summary
The aim of the present intervention study is to determine the effectiveness of manipulation techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Cervical Pain, Pain
- What is being tested?
- Spinal Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2018to 1 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Currently suffering spinal related pain (neck, thoracic or lumbar).
- Not receiving additional treatment for the treated condition.
Who cannot join
- Presence of red flags such as tumors or infection.
- Recent surgery.
- Fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Manipulation Effectiveness in Pain, Disability and Range of Motion.
The aim of the present intervention study is to determine the effectiveness of manipulation techniques.
Read the detailed description
Spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.
- Conditions
- Low Back Pain, Cervical Pain, Pain
- Being tested
- Spinal Manipulation, Sham manipulation
- Medical subject headings
- Low Back Pain, Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
Spinal manipulation based on orthopaedic manual therapy approach
Sham manipulationOther
Patients will receive simulated spinal manipulation without force application
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Active comparator | Spinal manipulation to the spine will be applied to participants enrolled in this group. Receives: Other: Spinal Manipulation |
| Sham manipulation | Sham comparator | Sham technique wich mimic the intervention manipulation with less force and different body location will be applied. Receives: Other: Sham manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogical scale
Pain was measured using a visual analogical scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate in the scale their current level of pain being higher values related with more intense pain
Measured: Change from baseline to 4 weeks and 6 months of follow up.
Secondary outcomes (2)
Oswestry Disability Index
The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Measured: Change from baseline to 4 weeks and 6 months of follow up.
Range of Motion
The spinal range of motion will be assessed with a digital inclinometer which indicates the results in angular degrees.
Measured: Change from baseline to 4 weeks and 6 months of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start20 Feb 2018 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Single blind parallel clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DAVID CRUZ DÍAZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- DAVID Curz DIAZ, PhD, Principal investigator, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190187
- Sponsor's protocol ID
- ManipulationUja
- Status last verified
- Jun 2017
- First submitted
- 24 Feb 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no intention to share the plan
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Manipulation Effectiveness in Pain, Disability and Range of Motion.
- ClinicalTrials.gov ID
- NCT03190187
- Acronym / sponsor ID
- ManipulationUja
- Conditions
- Low Back Pain, Cervical Pain, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- DAVID CRUZ DÍAZUniversity, hospital or other
- Study start
- 20 Feb 2018 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 16 Jun 2017 (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 aim of the present intervention study is to determine the effectiveness of manipulation techniques.
Detailed description
Spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Active comparator | Other: Spinal ManipulationSpinal manipulation to the spine will be applied to participants enrolled in this group. |
| Sham manipulation | Sham comparator | Other: Sham manipulationSham technique wich mimic the intervention manipulation with less force and different body location will be applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Currently suffering spinal related pain (neck, thoracic or lumbar).
- Not receiving additional treatment for the treated condition.
Key exclusion criteria (3 listed)
- Presence of red flags such as tumors or infection.
- Recent surgery.
- Fractures.
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 |
|---|---|---|
| Spinal ManipulationSpinal manipulation based on orthopaedic manual therapy approach | Other | Spinal manipulation |
| Sham manipulationPatients will receive simulated spinal manipulation without force application | Other | Sham manipulation |
Primary outcome
Visual analogical scale
Time frame: Change from baseline to 4 weeks and 6 months of follow up.
Pain was measured using a visual analogical scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate in the scale their current level of pain being higher values related with more intense pain
2 secondary outcomes
Oswestry Disability Index
Time frame: Change from baseline to 4 weeks and 6 months of follow up.
Range of Motion
Time frame: Change from baseline to 4 weeks and 6 months of follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No. There is no intention to share the plan
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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.
DAVID Curz DIAZ, PhD principal investigator
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Low Back Pain and Cervical Pain, run by DAVID CRUZ DÍAZ at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jun 2017. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Amat, PhD (+34953212121, amamat@ujaen.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogical scale (time frame: Change from baseline to 4 weeks and 6 months of follow up.). 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 16 Jun 2017; AzTrials last refreshed its copy on 3 Nov 2026.