Low Back PainNCT06207097
Compare the Effect of Exercise Program Plus Dry Needling Versus Elastic Taping
A study testing physiotherapy techniques in people with Low Back Pain, run by University of Americas - Chili at 1 site in Chile.
Trial summary
Low back pain is a common musculoskeletal health condition in society. It is a leading cause of disability globally and has created a significant burden in terms of work disability and high healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- physiotherapy techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2023to 18 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Workers of the University of the Americas, Santiago Centro Campus, Echaurren and República Headquarters
Who cannot join
- Not having a diagnosis of cancer,
- Hernia of the nucleus pulposus with neural symptoms,
- Pregnant
- History of recent surgery (<6 months)
- History of tumor
- History of spinal fracture
- People with belonephobia
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de las Americas
Santiago, Santiago Metropolitan, 7750495
About this study
Official title: Effect of Dry Needling Plus Exercise Compared to Elastic Taping Plus Exercise on the Reduction of Nonspecific Low Back Pain and Functionality
Low back pain is a common musculoskeletal health condition in society. It is a leading cause of disability globally and has created a significant burden in terms of work disability and high healthcare costs.
Studies on the treatment of combined therapies for non-specific low back pain are scarce, so it is not known in depth which intervention is the best for reducing pain. For this reason, the objective of this study was to evaluate and compare the effect of physical exercise plus dry needling versus physical exercise plus elastic bandage. For this, a randomized clinical trial was carried out with a total of 22 people, where pain was evaluated using the ENA scale and functionality using the Oswestry test. Participants received CORE stabilization exercises. CORE stability training has become a popular training trend and has begun to be applied in rehabilitation programs and sports medicine (1).
The expected results of the study are that the group that receives the physical exercise intervention plus dry needling will have better results in reducing the pain and functionality variable, evaluated with ENA and Oswestry in 4 sessions.
- Conditions
- Low Back Pain
- Being tested
- physiotherapy techniques
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy techniquesOther
Dry neeling: invasive physiotherapy technique where an acupuncture needle is used on painful points Elastic taping: physiotherapy technique where elastic bandage is used on the skin Exercise program: physical exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Dry needling plus exercise program. | Experimental | Not described Receives: Other: physiotherapy techniques |
| Elastic taping plus exercise program. | Experimental | Not described Receives: Other: physiotherapy techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (pain scale (VAS) 1 to 109
visual analog pain scale
Measured: 1 week
Secondary outcomes (1)
dysfunction (percentage of disability due to low back pain (from 0 to 10%))
Evaluation of dysfunction due to low back pain with the Oswestry Dysfunction Scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2023
- Study completion18 Dec 2023
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Astudillo Ganora, University of Americas - Chili
- Investigators
- Ignacio Astudillo, PhD, Principal investigator, Universidad de las Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207097
- Sponsor's protocol ID
- CEC_FP_2023022
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Needling Plus Exercise Compared to Elastic Taping Plus Exercise on the Reduction of Nonspecific Low Back Pain and Functionality
- ClinicalTrials.gov ID
- NCT06207097
- Acronym / sponsor ID
- CEC_FP_2023022
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 16 Jan 2024 (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.
Low back pain is a common musculoskeletal health condition in society. It is a leading cause of disability globally and has created a significant burden in terms of work disability and high healthcare costs.
Studies on the treatment of combined therapies for non-specific low back pain are scarce, so it is not known in depth which intervention is the best for reducing pain. For this reason, the objective of this study was to evaluate and compare the effect of physical exercise plus dry needling versus physical exercise plus elastic bandage. For this, a randomized clinical trial was carried out with a total of 22 people, where pain was evaluated using the ENA scale and functionality using the Oswestry test. Participants received CORE stabilization exercises. CORE stability training has become a popular training trend and has begun to be applied in rehabilitation programs and sports medicine (1).
The expected results of the study are that the group that receives the physical exercise intervention plus dry needling will have better results in reducing the pain and functionality variable, evaluated with ENA and Oswestry in 4 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling plus exercise program. | Experimental | Other: physiotherapy techniques |
| Elastic taping plus exercise program. | Experimental | Other: physiotherapy techniques |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Workers of the University of the Americas, Santiago Centro Campus, Echaurren and República Headquarters
Key exclusion criteria (7 listed)
- Not having a diagnosis of cancer,
- Hernia of the nucleus pulposus with neural symptoms,
- Pregnant
- History of recent surgery (<6 months)
- History of tumor
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 |
|---|---|---|
| physiotherapy techniquesDry neeling: invasive physiotherapy technique where an acupuncture needle is used on painful points Elastic taping: physiotherapy technique where elastic bandage is used on the skin Exercise program: physical exercise prescription | Other | Dry needling plus exercise program., Elastic taping plus exercise program. |
Primary outcome
Pain (pain scale (VAS) 1 to 109
Time frame: 1 week
visual analog pain scale
1 secondary outcome
dysfunction (percentage of disability due to low back pain (from 0 to 10%))
Time frame: 1 week
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 16 Jan 2024.
- 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.
Ignacio Astudillo, PhD principal investigator
Universidad de las Americas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy techniques in people with Low Back Pain, run by University of Americas - Chili at 1 site in Chile.
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 16 Jan 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 Chile. 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 (pain scale (VAS) 1 to 109 (time frame: 1 week). 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 Jan 2024.