Back PainPhase 1/2CBNPNCT00964717
Chiropractic for Back and Neck Pain in an Emergency Department Setting
A Phase 1/2 study testing real chiropractic 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 Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting Chiropractic 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 chiropractic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- May 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
- Active pregnancy
- Active inflammatory arthritis
- History of CVA
- Open wounds
Show all 13Show fewer
- 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
- Received a chiropractic treatment in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Integrative Approach Utilizing Chiropractic as an Add On Therapy for the Treatment 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 Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting
Chiropractic is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an effective therapy for simple back and neck pain in an emergency room (ER) setting.
This study will examine weather Chiropractic 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. Chiropractic will be performed as an add on therapy on top of analgesic therapy.
- Being tested
- real chiropractic, Sham Chiropractic
- 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 chiropracticProcedure or surgery
real chiropractic manipulation
Sham ChiropracticProcedure or surgery
Placebo stimulation using 'activator' thumper
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic | Active comparator | Real Chiropractic treatment Receives: Procedure: real chiropractic |
| Sham Chiropractic | Sham comparator | stimulation utilizing 'activator' thumper Receives: Procedure: Sham Chiropractic |
| No treatment | No intervention | No add on therapy - patients lay down for a period of 15 minutes without any treatment or 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 chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Measured: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
Secondary outcomes (4)
A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer
Measured: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
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: Immidiatly after treatment
A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
Measured: 24 hours after treatment
A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Measured: 1 hour after the treatment and again after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startMay 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
- 52 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, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964717
- Sponsor's protocol ID
- 126/08
- Acronym
- CBNP
- Status last verified
- Jan 2012
- First submitted
- 11 Aug 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 Chiropractic as an Add On Therapy for the Treatment Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00964717
- Acronym / sponsor ID
- CBNP / 126/08
- Keywords
- back pain, neck pain, anxiety, range of motion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Aug 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 Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting
Chiropractic is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an effective therapy for simple back and neck pain in an emergency room (ER) setting.
This study will examine weather Chiropractic 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. Chiropractic 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 |
|---|---|---|
| Chiropractic | Active comparator | Procedure: real chiropracticReal Chiropractic treatment |
| Sham Chiropractic | Sham comparator | Procedure: Sham Chiropracticstimulation utilizing 'activator' thumper |
| No treatment | No intervention | –No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- Active pregnancy
- Active inflammatory arthritis
- History of CVA
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 chiropracticreal chiropractic manipulation | Procedure or surgery | Chiropractic |
| Sham ChiropracticPlacebo stimulation using 'activator' thumper | Procedure or surgery | Sham Chiropractic |
Primary outcome
A comparable difference in pain levels between a combined medication and chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Time frame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
4 secondary outcomes
A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer
Time frame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
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: Immidiatly after treatment
A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
Time frame: 24 hours after treatment
A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Time frame: 1 hour after the treatment and again after 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 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
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 chiropractic 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 4 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 chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS) (time frame: 30 minutes after medication, Immidiatly after treatment and 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.