Low Back PainNCT00163124
A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique
A study testing spinal manipulation & patient education/nutrition in people with Low Back Pain and Headache, run by Parker College of Chiropractic at 1 site in United States.
Trial summary
There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Low Back Pain, Headache, Shoulder Pain
- What is being tested?
- spinal manipulation & patient education/nutrition
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2005
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic musculoskeletal pain ability to communicate in English
Who cannot join
- pregnancy contraindications to manipulation pending litigation chiropractic care within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Adjustive Technique
There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. The hypothesis is that there is no difference between forceful and non-forceful approaches to treatment.
Read the detailed description
The comparison will permit a one month treatment period for both techniques and a three week follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at three weeks following the termination of care.
- Conditions
- Low Back Pain, Headache, Shoulder Pain
- Being tested
- spinal manipulation & patient education/nutrition
- Keywords
- chiropractic, spinal manipulation, low back pain
- Medical subject headings
- Low Back Pain, Headache, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulation & patient education/nutritionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Disability Index (PDI)
Secondary outcomes (3)
Beck Depression Inventory
Patient Expectation
Evaluation of Clinic Services
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMar 2005
- Study completionAug 2005
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
- Factorial
- Masking
- Single blind
- Enrolment
- 155 participants
Sponsor and investigators
- Lead sponsor
- Parker College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Cheryl Hawk, PhD DC, Principal investigator, Parker College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163124
- Sponsor's protocol ID
- PCC2005-003
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 13 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Adjustive Technique
- ClinicalTrials.gov ID
- NCT00163124
- Acronym / sponsor ID
- PCC2005-003
- Conditions
- Low Back Pain, Headache, Shoulder Pain
- Keywords
- chiropractic, spinal manipulation, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants
- Lead sponsor
- Parker College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Aug 2005
- First posted
- 13 Sep 2005 (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.
There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. The hypothesis is that there is no difference between forceful and non-forceful approaches to treatment.
Detailed description
The comparison will permit a one month treatment period for both techniques and a three week follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at three weeks following the termination of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic musculoskeletal pain ability to communicate in English
Key exclusion criteria (1 listed)
- pregnancy contraindications to manipulation pending litigation chiropractic care within the last month
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 & patient education/nutrition | Procedure or surgery | – |
Primary outcome
Pain Disability Index (PDI)
3 secondary outcomes
Beck Depression Inventory
Patient Expectation
Evaluation of Clinic Services
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 13 Sep 2005.
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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.
Cheryl Hawk, PhD DC principal investigator
Parker College of Chiropractic
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 & patient education/nutrition in people with Low Back Pain and Headache, run by Parker College of Chiropractic at 1 site in United States.
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 1 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 13 Sep 2005. 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 United States. 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 Disability Index (PDI). 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 13 Sep 2005.