Back PainNCT05080374
Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain
A study testing Spinal Manipulation + exercise program, Spinal manipulation + Kinesiotaping and spinal manipulation + respiratory exercise in people with Back Pain and Lumbar Pain Syndrome, run by Ignacio Alejandro Astudillo Ganora at 1 site in Spain.
Trial summary
Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Lumbar Pain Syndrome, Back Pain, Low
- What is being tested?
- Spinal Manipulation + exercise program, Spinal manipulation + Kinesiotaping and spinal manipulation + respiratory exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 11 Aug 2021to 11 Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- with nonspecific low back pain
Who cannot join
- chronic low back pain (more than 3 months)
- spinal surgeries
- red flags for spinal manipulation (osteoporosis, bone metastasis, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combining High Speed Low Amplitude Spinal Manipulation (HVLA) With Functional Elastic Bandage, Diaphragm Training and a Lumbar Exercise Program in Patients With Nonspecific Low Back Pain: a Randomized Clinical Trial.
Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person will have low back pain during their life ( 3), lumbago produces 300,000 years lived with disability (ADL), being the first burden of disease in Chile, surpassing hypertensive heart disease and depression (4). There are many therapeutic approaches to the management of nonspecific low back pain, including high-speed, low-amplitude spinal manipulations (5). This technique consists of applying a short and rapid force at the level of the joint that is restricted, in order to restore normal joint mobility. The physiological effects of manipulations are not sufficiently studied, but some authors (6) (7) suggest that the nervous system is the mediator of the effects of spinal manipulation. Among non-pharmacological interventions, numerous clinical guidelines recommend the use of therapeutic exercise for low back pain (8), including a wide variety of types of recommended exercises, the most traditionally recommended being aerobic exercises, exercises that involve stretching postures of the back. vertebral musculature, strengthening and strength exercises (9) and central stabilization exercises (10). Recently, the effects of inspiratory muscle and diaphragm training exercises in patients with low back pain are being investigated (11). The application of an elastic bandage (12) in the lumbar area generates a proprioceptive signal through the skin, producing analgesia and a feeling of support in the area.
Objectives: To compare the effects of different therapeutic approaches in combination with spinal manipulation.
Read more
Design and method: Single-blind randomized clinical trial Results: Significant differences are expected before and after treatment and differences between groups.
Conclusion: The aims of this study is to demonstrate that High speed and low amplitude spinal manipulation plus other conservative treatment is a valid therapeutic strategy for the management of nonspecific low back pain
- Conditions
- Back Pain, Lumbar Pain Syndrome, Back Pain, Low
- Being tested
- Spinal Manipulation + exercise program, Spinal manipulation + Kinesiotaping, spinal manipulation + respiratory exercise
- Medical subject headings
- Back Pain, Somatoform Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manipulation + exercise programOther
high-speed, low-amplitude spinal manipulation plus a trunk exercise program
Spinal manipulation + KinesiotapingOther
high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area
spinal manipulation + respiratory exerciseOther
high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles
| Study group | Role | What they receive |
|---|---|---|
| HVLA + exercise Group | Experimental | Spinal manipulation (HVLA) + trunk exercise program Receives: Other: Spinal Manipulation + exercise program |
| HVLA + kinesiotaping group | Experimental | Spinal manipulation (HVLA) + Kinesiotaping (lumbar) Receives: Other: Spinal manipulation + Kinesiotaping |
| HVLA + Respiratory exercise group | Experimental | Spinal manipulation (HVLA) + respiratory exercise program Receives: Other: spinal manipulation + respiratory exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pain EVA
observe changes in pain through visual analogue scale (VAS) 0 to 10
Measured: baseline after 6 weeks and a month
Changes in pain pressure algometers
observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)
Measured: baseline after 6 weeks and a month
Biomechanical changes (lateral tilt test)
observe the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)
Measured: baseline after 6 weeks and a month
biomechanical changes (finger-floor test)
observe the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)
Measured: baseline after 6 weeks and a month
Biomechanical changes (shober test)
observe the changes in the biomechanics of the spine through the Shober test (Schöber test. It is performed with the patient standing and the examiner on his back. A point is indicated that locates L5 (at the height of the dimples of Venus or the iliac crests are used, which correspond to L4, and is marked 1cm below) and a second point is marked 10cm above.)
Measured: baseline after 6 weeks and a month
changes in function
observe changes in disability due to nonspecific low back pain through the Oswestry test (The Oswestry Test comprises 10 items, of 10 points each, with a maximum of 100, this score being the worst possible functional state.)
Measured: baseline after 6 weeks and a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start11 Aug 2021
- Primary completion11 Sep 2021
- Study completion11 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignacio Alejandro Astudillo Ganora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignacio Alejandro Astudillo Ganora, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080374
- Sponsor's protocol ID
- 3500/2021
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining High Speed Low Amplitude Spinal Manipulation (HVLA) With Functional Elastic Bandage, Diaphragm Training and a Lumbar Exercise Program in Patients With Nonspecific Low Back Pain: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05080374
- Acronym / sponsor ID
- 3500/2021
- Conditions
- Back Pain, Lumbar Pain Syndrome, Back Pain, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ignacio Alejandro Astudillo GanoraUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 11 Sep 2021 (actual)
- First posted
- 15 Oct 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.
Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person will have low back pain during their life ( 3), lumbago produces 300,000 years lived with disability (ADL), being the first burden of disease in Chile, surpassing hypertensive heart disease and depression (4). There are many therapeutic approaches to the management of nonspecific low back pain, including high-speed, low-amplitude spinal manipulations (5). This technique consists of applying a short and rapid force at the level of the joint that is restricted, in order to restore normal joint mobility. The physiological effects of manipulations are not sufficiently studied, but some authors (6) (7) suggest that the nervous system is the mediator of the effects of spinal manipulation. Among non-pharmacological interventions, numerous clinical guidelines recommend the use of therapeutic exercise for low back pain (8), including a wide variety of types of recommended exercises, the most traditionally recommended being aerobic exercises, exercises that involve stretching postures of the back. vertebral musculature, strengthening and strength exercises (9) and central stabilization exercises (10). Recently, the effects of inspiratory muscle and diaphragm training exercises in patients with low back pain are being investigated (11). The application of an elastic bandage (12) in the lumbar area generates a proprioceptive signal through the skin, producing analgesia and a feeling of support in the area.
Objectives: To compare the effects of different therapeutic approaches in combination with spinal manipulation.
Design and method: Single-blind randomized clinical trial Results: Significant differences are expected before and after treatment and differences between groups.
Conclusion: The aims of this study is to demonstrate that High speed and low amplitude spinal manipulation plus other conservative treatment is a valid therapeutic strategy for the management of nonspecific low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVLA + exercise Group | Experimental | Other: Spinal Manipulation + exercise programSpinal manipulation (HVLA) + trunk exercise program |
| HVLA + kinesiotaping group | Experimental | Other: Spinal manipulation + KinesiotapingSpinal manipulation (HVLA) + Kinesiotaping (lumbar) |
| HVLA + Respiratory exercise group | Experimental | Other: spinal manipulation + respiratory exerciseSpinal manipulation (HVLA) + respiratory exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years
- with nonspecific low back pain
Key exclusion criteria (3 listed)
- chronic low back pain (more than 3 months)
- spinal surgeries
- red flags for spinal manipulation (osteoporosis, bone metastasis, etc)
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 Manipulation + exercise programhigh-speed, low-amplitude spinal manipulation plus a trunk exercise program | Other | HVLA + exercise Group |
| Spinal manipulation + Kinesiotapinghigh-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area | Other | HVLA + kinesiotaping group |
| spinal manipulation + respiratory exercisehigh-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles | Other | HVLA + Respiratory exercise group |
Primary outcome
changes in pain EVA
Time frame: baseline after 6 weeks and a month
observe changes in pain through visual analogue scale (VAS) 0 to 10
Changes in pain pressure algometers
Time frame: baseline after 6 weeks and a month
observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)
Biomechanical changes (lateral tilt test)
Time frame: baseline after 6 weeks and a month
observe the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)
biomechanical changes (finger-floor test)
Time frame: baseline after 6 weeks and a month
observe the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)
Biomechanical changes (shober test)
Time frame: baseline after 6 weeks and a month
observe the changes in the biomechanics of the spine through the Shober test (Schöber test. It is performed with the patient standing and the examiner on his back. A point is indicated that locates L5 (at the height of the dimples of Venus or the iliac crests are used, which correspond to L4, and is marked 1cm below) and a second point is marked 10cm above.)
changes in function
Time frame: baseline after 6 weeks and a month
observe changes in disability due to nonspecific low back pain through the Oswestry test (The Oswestry Test comprises 10 items, of 10 points each, with a maximum of 100, this score being the worst possible functional state.)
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 15 Oct 2021.
- 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 Spinal Manipulation + exercise program, Spinal manipulation + Kinesiotaping and spinal manipulation + respiratory exercise in people with Back Pain and Lumbar Pain Syndrome, run by Ignacio Alejandro Astudillo Ganora 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: finished, as of the sponsor's last update on 15 Oct 2021. 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. 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?
changes in pain EVA (time frame: baseline after 6 weeks and a month). 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?
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 15 Oct 2021.