Manual and Manipulative Therapy for Low Back Pain

NCT ID: NCT00632060

Last Updated: 2008-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-07-31

Brief 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 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:

1. 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

2. 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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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.

Group Type: EXPERIMENTAL

Manual / Manipulative Therapy (M/MT)

Intervention Type: PROCEDURE

Subjects will receive M/MT twice a week for 4 weeks

Interventions

Manual / Manipulative Therapy (M/MT)

Subjects will receive M/MT twice a week for 4 weeks

Intervention Type: PROCEDURE

Other Intervention Names

M/MT

Eligibility Criteria

Inclusion Criteria

• Active Duty
• Aged 18-35
• New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain

Exclusion Criteria

• 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)
• 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?"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palmer Center for Chiropractic Research (PCCR)

OTHER

Sponsor Role: collaborator

William Beaumont Army Medical Center

FED

Sponsor Role: collaborator

United States Army Fort Bliss

UNKNOWN

Sponsor Role: collaborator

Samueli Institute for Information Biology

OTHER

Sponsor Role: lead

Responsible Party

William Beaumont Army Medical Center (WBAMC)

Principal Investigators

CPT Keith P Myers, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Army Medical Center

Locations

Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX

El Paso, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roxana Delgado, MS

Role: CONTACT

roxana.delgado@amedd.army.mil

915-569-3245/3245

CPT Keith P Myers, MD

Role: CONTACT

keith.myers@amedd.army.mil

915-569-3245

Facility Contacts

Roxana Delgado, MS

Role: primary

roxana.delgado@amedd.army.mil

915-569-2857

References

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.

Reference Type: DERIVED

PMID: 23060056 (View on PubMed)

Other Identifiers

WBAMC #06/05; USUHS TX781-AX-2

Identifier Type: -

Identifier Source: secondary_id

1 EA-0000055

Identifier Type: -

Identifier Source: org_study_id