Back PainPhase 1/2ABNPNCT00859365
Acupuncture for Back and Neck Pain in an Emergency Room Setting
A Phase 1/2 study testing Real Acupuncture in people with Back Pain and Neck Pain, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting Acupuncture is well established as an effective treatment for back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Real Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Sep 2011
- Phase
- Phase 1/2
- 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
- Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
- Agreed to a physical examination and by an orthopedic physician and X-ray
- Diagnosis of simple back pain with levels of 4<NRS at least
- Agreed and able to fill pain, anxiety and satisfactory questioners
- Agreed and able to sign informed consent
Who cannot join
- Fracture, sprain or neurological deficit during physical examination
- Pain scale of NRS< 4
- Referred or radiating pain
- Active pregnancy
- Active inflammatory arthritis
- History of CVA
Show all 13Show fewer
- Open wounds
- Acute malignancy with life expectancy of less than 5 years
- Experience with acupuncture treatments
- History of drug addiction
- History of osteoporosis
- Declined or unable to sign informed consent
- Soldiers in active military service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Integrative Approach Utilizing Acupuncture as an add-on Therapy for the Treatment of Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting
Acupuncture is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective therapy for simple back and neck pain in an ER setting.
This study will examine weather Acupuncture can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Acupuncture will be performed as an add on therapy on top of analgesic therapy.
- Conditions
- Back Pain, Neck Pain, Anxiety, Range of Motion
- Being tested
- Real Acupuncture, Placebo Acupuncture, No intervention
- Keywords
- back pain, neck pain, anxiety, range of motion
- Medical subject headings
- Back Pain, Neck Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real AcupunctureProcedure or surgery
Real acupuncture treatment in real acupuncture points
Placebo AcupunctureProcedure or surgery
empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator
No interventionProcedure or surgery
Patients lay down for a period of 35 minutes without any treatment o intervention
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Real Acupuncture Receives: Procedure: Real Acupuncture |
| 2 Placebo acupuncture | Placebo comparator | Not described Receives: Procedure: Placebo Acupuncture |
| 3 No treatment | No intervention | No treatment performed Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Measured: At day of treatment, after 24 hrs
Secondary outcomes (4)
4.2.1 A comparable difference in range of motion between a combined medication and acupuncture treatment to medication treatment alone as measured by Spine Scan Device and physical exam using gonoimeter
Measured: day of treatment, after 24 hrs
4.2.2 A comparable difference in patient self reported anxiety assessed by Hebrew version of the anxiety and somatization sections of the Symptom Check List-90 questioner (SCL-90)
Measured: day of treatment
4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment
Measured: day of treatment and after 24 hours
4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Measured: day of treatment, after 1 weekl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2011
- Study completionSep 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Shmuel Bar-Haim, MD, Principal investigator, Asaf Harofeh Medical Center, Zerifin, IsraelAmos Ziv, M.Sc, Study director, Asaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859365
- Sponsor's protocol ID
- 127/08
- Acronym
- ABNP
- Status last verified
- Jan 2012
- First submitted
- 10 Mar 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Integrative Approach Utilizing Acupuncture as an add-on Therapy for the Treatment of Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00859365
- Acronym / sponsor ID
- ABNP / 127/08
- Conditions
- Back Pain, Neck Pain, Anxiety, Range of Motion
- Keywords
- back pain, neck pain, anxiety, range of motion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Mar 2009 (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.
This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting
Acupuncture is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective therapy for simple back and neck pain in an ER setting.
This study will examine weather Acupuncture can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Acupuncture will be performed as an add on therapy on top of analgesic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Real AcupunctureReal Acupuncture |
| 2 Placebo acupuncture | Placebo comparator | Procedure: Placebo Acupuncture |
| 3 No treatment | No intervention | Procedure: No interventionNo treatment performed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
- Agreed to a physical examination and by an orthopedic physician and X-ray
- Diagnosis of simple back pain with levels of 4<NRS at least
- Agreed and able to fill pain, anxiety and satisfactory questioners
- Agreed and able to sign informed consent
Key exclusion criteria (13 listed)
- Fracture, sprain or neurological deficit during physical examination
- Pain scale of NRS< 4
- Referred or radiating pain
- Active pregnancy
- Active inflammatory arthritis
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 |
|---|---|---|
| Real AcupunctureReal acupuncture treatment in real acupuncture points | Procedure or surgery | Acupuncture |
| Placebo Acupunctureempty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator | Procedure or surgery | 2 Placebo acupuncture |
| No interventionPatients lay down for a period of 35 minutes without any treatment o intervention | Procedure or surgery | 3 No treatment |
Primary outcome
A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Time frame: At day of treatment, after 24 hrs
4 secondary outcomes
4.2.1 A comparable difference in range of motion between a combined medication and acupuncture treatment to medication treatment alone as measured by Spine Scan Device and physical exam using gonoimeter
Time frame: day of treatment, after 24 hrs
4.2.2 A comparable difference in patient self reported anxiety assessed by Hebrew version of the anxiety and somatization sections of the Symptom Check List-90 questioner (SCL-90)
Time frame: day of treatment
4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment
Time frame: day of treatment and after 24 hours
4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Time frame: day of treatment, after 1 weekl
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 31 Jan 2012.
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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.
Shmuel Bar-Haim, MD principal investigator
Asaf Harofeh Medical Center, Zerifin, Israel
Amos Ziv, M.Sc study director
Asaf Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Real Acupuncture in people with Back Pain and Neck Pain, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 5 inclusion and 13 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 31 Jan 2012. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS) (time frame: At day of treatment, after 24 hrs). 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 31 Jan 2012.