Low Back PainNCT00632060
Manual and Manipulative Therapy for Low Back Pain
A study testing Manual / Manipulative Therapy (M/MT) in people with Low Back Pain, run by Samueli Institute for Information Biology at 1 site in United States.
Trial summary
The specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manual / Manipulative Therapy (M/MT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2009
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active Duty
- Aged 18-35
- New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain
Who cannot join
- LBP from other somatic tissues as determined by history, examination, and course (i.e. pain referred from visceral conditions)
- Radicular pain worse than back pain
- Co-morbid pathology or poor health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study
- Bone and joint pathology contraindicating patient for M/MT. Patients with spinal fracture, tumors, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded from the study
- Other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders or anticoagulant therapy)
- Pregnancy (all potential female participants will undergo pregnancy testing)
Show all 10Show fewer
- Use of manipulative care for any reason within the past month
- Unable to follow course of care for four weeks
- Unable to give informed consent for any reason
- Unable to confirm that they will not be deployed during the course of the study: "Will you be deployed, receiving orders for a distant temporary active duty assignment, attending training at a distant sight, or otherwise absent from Ft. Bliss over the next 6 weeks?"
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX
El Paso, Texas, 79920
Roxana Delgado, MS, 915-569-2857, roxana.delgado@amedd.army.mil
CPT Keith P Myers, MD
About this study
Official title: The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study
The specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition of M/MT to standard care to decrease pain and increase function for patients with low back pain.
The following two hypotheses will guide the data collection:
- The primary hypothesis is that the addition of acourse of M/MT to standard care for low back pain will decrease pain at 4 weeks when compared to standard care alone
- In addition, the secondary hypothesis will be that the addition of a course of M/MT to standard care for low back pain will decrease pain and increase function over 2 and 4 weeks when compared to standard care alone
Read the detailed description
Musculoskeletal injuries are among the highest frequency injuries in military personnel(1). These may result from training exercises, normal job duties, or recreational activities (2). Such injuries may cause reduced levels of performance and therefore decrease military readiness (1). This prospective, randomized, clinical trial compares manual/manipulative therapy (M/MT) and standard care to standard care alone for episodes of low back pain. Patients will be randomized to standard care or standard care plus M/MT. Standard care consists of medication prescribed by the credentialed medical provider; M/MT will be delivered by the chiropractor physician. The trial time period will be 4 weeks with outcome measurements at intake, 2 weeks, and 4 weeks. Outcome measures include the Visual Analogue Scale (VAS) for pain, Roland-Morris Low Back Pain and Disability Questionnaire (RDQ), the Back Pain Functional Scale for assessing function (3), Global Improvement Questionnaire for patient perception regarding improvement in function, Patient Expectation and Patient Satisfaction Questionnaires to examine patient expectations toward care and reception of that care, and drug use and profiles. The SF-36 will be used to measure the general health component and quality of life of our sample (4). This will be a pragmatic study that will allow us the opportunity to develop further investigations leading to a larger scale and more robust clinical trial. In addition, this study will provide information on the challenges and opportunities involved in conducting clinical research concerning M/MT in a military setting and may lead to additional studies at a wider number of bases throughout the US.
- Conditions
- Low Back Pain
- Being tested
- Manual / Manipulative Therapy (M/MT)
- Keywords
- Low Back Pain, Manual / Manipulative Therapy
- 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.
Manual / Manipulative Therapy (M/MT)Procedure or surgery
Also called M/MT
Subjects will receive M/MT twice a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard Care Control Group - Participants randomized to the standard care group will continue their use of non-prescription or prescription medication and reduced duty loads, as prescribed by the credentialed medical provider. |
| 2 | Experimental | Manual / Manipulative Therapy Group: Participants randomized to the M/MT group will receive a course of M/MT along with standard care. The patient will see the chiropractor twice a week for the entire course of the study, regardless of manipulation or not. Receives: Procedure: Manual / Manipulative Therapy (M/MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased pain
Measured: Baseline, 2 weeks, 4 weeks
Secondary outcomes (1)
Increased function
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- Palmer Center for Chiropractic Research (PCCR), William Beaumont Army Medical Center, United States Army Fort Bliss
- Investigators
- CPT Keith P Myers, MD, Principal investigator, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632060
- Sponsor's protocol ID
- 1 EA-0000055
- Other IDs
- WBAMC #06/05; USUHS TX781-AX-2
- Status last verified
- Feb 2008
- First submitted
- 29 Feb 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
Publications
Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7.
PubMed 23060056
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00632060
- Acronym / sponsor ID
- 1 EA-0000055
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Manual / Manipulative Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- Palmer Center for Chiropractic Research (PCCR), William Beaumont Army Medical Center, United States Army Fort Bliss
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 10 Mar 2008 (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 specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition of M/MT to standard care to decrease pain and increase function for patients with low back pain.
The following two hypotheses will guide the data collection:
- The primary hypothesis is that the addition of acourse of M/MT to standard care for low back pain will decrease pain at 4 weeks when compared to standard care alone
- In addition, the secondary hypothesis will be that the addition of a course of M/MT to standard care for low back pain will decrease pain and increase function over 2 and 4 weeks when compared to standard care alone
Detailed description
Musculoskeletal injuries are among the highest frequency injuries in military personnel(1). These may result from training exercises, normal job duties, or recreational activities (2). Such injuries may cause reduced levels of performance and therefore decrease military readiness (1). This prospective, randomized, clinical trial compares manual/manipulative therapy (M/MT) and standard care to standard care alone for episodes of low back pain. Patients will be randomized to standard care or standard care plus M/MT. Standard care consists of medication prescribed by the credentialed medical provider; M/MT will be delivered by the chiropractor physician. The trial time period will be 4 weeks with outcome measurements at intake, 2 weeks, and 4 weeks. Outcome measures include the Visual Analogue Scale (VAS) for pain, Roland-Morris Low Back Pain and Disability Questionnaire (RDQ), the Back Pain Functional Scale for assessing function (3), Global Improvement Questionnaire for patient perception regarding improvement in function, Patient Expectation and Patient Satisfaction Questionnaires to examine patient expectations toward care and reception of that care, and drug use and profiles. The SF-36 will be used to measure the general health component and quality of life of our sample (4). This will be a pragmatic study that will allow us the opportunity to develop further investigations leading to a larger scale and more robust clinical trial. In addition, this study will provide information on the challenges and opportunities involved in conducting clinical research concerning M/MT in a military setting and may lead to additional studies at a wider number of bases throughout the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard Care Control Group - Participants randomized to the standard care group will continue their use of non-prescription or prescription medication and reduced duty loads, as prescribed by the credentialed medical provider. |
| 2 | Experimental | Procedure: Manual / Manipulative Therapy (M/MT)Manual / Manipulative Therapy Group: Participants randomized to the M/MT group will receive a course of M/MT along with standard care. The patient will see the chiropractor twice a week for the entire course of the study, regardless of manipulation or not. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active Duty
- Aged 18-35
- New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain
Key exclusion criteria (10 listed)
- LBP from other somatic tissues as determined by history, examination, and course (i.e. pain referred from visceral conditions)
- Radicular pain worse than back pain
- Co-morbid pathology or poor health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study
- Bone and joint pathology contraindicating patient for M/MT. Patients with spinal fracture, tumors, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded from the study
- Other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders or anticoagulant therapy)
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 |
|---|---|---|
| Manual / Manipulative Therapy (M/MT)Also: M/MTSubjects will receive M/MT twice a week for 4 weeks | Procedure or surgery | 2 |
Primary outcome
Decreased pain
Time frame: Baseline, 2 weeks, 4 weeks
1 secondary outcome
Increased function
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
- Derived from this study: PubMed 23060056Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7.
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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.
CPT Keith P Myers, MD principal investigator
William Beaumont Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual / Manipulative Therapy (M/MT) in people with Low Back Pain, run by Samueli Institute for Information Biology 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 3 inclusion and 10 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 10 Mar 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roxana Delgado, MS (915-569-3245/3245, roxana.delgado@amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased pain (time frame: Baseline, 2 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632060, which also lists 1 linked publication.
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 10 Mar 2008.