Back PainPUCTURE-CVNCT01231425
Prospective Study of Clinical Utility of Acupuncture in Back Pain
An observational study of Back Pain and Musculoskeletal Disease, run by Group G-6 at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Musculoskeletal Disease
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Oct 2012
- Phase
- Observational
- 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
Study population: The study population is patients who go to the Acupuncture Office diagnosed of cervical, thoracic or lumbar pain caused by musculoskeletal diseases, pretreated with pharmacological treatment, they start treatment with acupuncture as adjunctive therapy for symptoms of their disease. Initially it was estimated that the optimal number of patients included to achieve the objectives of the study is 102 patients
Who may be able to join
- Patients of both sexes, aged 18 and over
- Patients diagnosed with back pain: cervical, thoracic or lumbar.
- Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist
- Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist
- Patients with sufficient cultural and educational level to complete the health questionnaires required in the study
- Patients who have given their written informed consent to participate in the study
Who cannot join
- Patient with any illness and that medical opinions recommended not to participate in the study
- Patient can not respond to questionnaires administered during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.
Read the detailed description
Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.
The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.
- Conditions
- Back Pain, Musculoskeletal Disease
- Keywords
- Back pain, cervicalgia, dorsalgia, lumbalgia, acupuncture
- Medical subject headings
- Back Pain, Musculoskeletal Diseases, Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With usual concomitant treatment | Two observational cohorts of patients will be evaluated: with and without concomitant analgesic/ antiinflammatory drugs. The objective is evaluate that both therapies (drugs and acupuncture) could be used as adjunctive therapy in order to maximize the analgesia that could be reached | |
| Without usual concomitant treatment | This group include patients that are not been treated with analgesic drugs at the beginning of the study. As an observational and naturalistic study any indicated treatment is allowed in any time |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS: Visual Analogic Scale of pain
Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS). This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study
Measured: 10 weekly visits
Secondary outcomes (5)
Sheehan Disability Questionnaire
Sheehan Disability Questionnaire, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
Measured: First Visit (week 1) and Final Visit (week 10)
Evaluation of the Scale Hospital Anxiety Depression (HAD)
Scale Hospital Anxiety Depression (HAD), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
Measured: First Visit (week 1) and Final Visit (week 10)
Health Questionnaire EuroQol-5D
Health Questionnaire EuroQol-5D, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
Measured: First Visit (week 1) and Final Visit (week 10)
Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)
Assessment of sleep with the integrated scale MOS (Medical Outcomes Study), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
Measured: First Visit (week 1) and Final Visit (week 10)
McGill Pain Questionnaire
A secondary evaluation of pain suffered by the patients will be evaluated using the validated McGill Pain Questionnaire. This questionnaire will be adminstrated in all 10 visits and it will be showed its evolution (decrease) along the study
Measured: 10 weekly visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionOct 2012 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Group G-6
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Valentin Martin, MD, PhD, Principal investigator, Grupo G6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231425
- Sponsor's protocol ID
- GE6-ACU-2010-01
- Acronym
- PUCTURE-CV
- Status last verified
- Nov 2011
- First submitted
- 28 Sep 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
- ClinicalTrials.gov ID
- NCT01231425
- Acronym / sponsor ID
- PUCTURE-CV / GE6-ACU-2010-01
- Conditions
- Back Pain, Musculoskeletal Disease
- Keywords
- Back pain, cervicalgia, dorsalgia, lumbalgia, acupuncture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Group G-6Research network
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 1 Nov 2010 (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.
The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.
Detailed description
Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.
The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With usual concomitant treatment | – | –Two observational cohorts of patients will be evaluated: with and without concomitant analgesic/ antiinflammatory drugs. The objective is evaluate that both therapies (drugs and acupuncture) could be used as adjunctive therapy in order to maximize the analgesia that could be reached |
| Without usual concomitant treatment | – | –This group include patients that are not been treated with analgesic drugs at the beginning of the study. As an observational and naturalistic study any indicated treatment is allowed in any time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients who go to the Acupuncture Office diagnosed of cervical, thoracic or lumbar pain caused by musculoskeletal diseases, pretreated with pharmacological treatment, they start treatment with acupuncture as adjunctive therapy for symptoms of their disease. Initially it was estimated that the optimal number of patients included to achieve the objectives of the study is 102 patients
Key inclusion criteria (6 listed)
- Patients of both sexes, aged 18 and over
- Patients diagnosed with back pain: cervical, thoracic or lumbar.
- Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist
- Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist
- Patients with sufficient cultural and educational level to complete the health questionnaires required in the study
Key exclusion criteria (2 listed)
- Patient with any illness and that medical opinions recommended not to participate in the study
- Patient can not respond to questionnaires administered during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS: Visual Analogic Scale of pain
Time frame: 10 weekly visits
Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS). This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study
5 secondary outcomes
Sheehan Disability Questionnaire
Time frame: First Visit (week 1) and Final Visit (week 10)
Evaluation of the Scale Hospital Anxiety Depression (HAD)
Time frame: First Visit (week 1) and Final Visit (week 10)
Health Questionnaire EuroQol-5D
Time frame: First Visit (week 1) and Final Visit (week 10)
Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)
Time frame: First Visit (week 1) and Final Visit (week 10)
McGill Pain Questionnaire
Time frame: 10 weekly visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
Valentin Martin, MD, PhD principal investigator
Grupo G6
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain and Musculoskeletal Disease, run by Group G-6 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 6 inclusion and 2 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 8 Nov 2011. 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?
Results are not available in the source record.
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?
VAS: Visual Analogic Scale of pain (time frame: 10 weekly visits). 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 8 Nov 2011.