Manual and Manipulative Therapy for Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Samueli Institute for Information Biology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Palmer Center for Chiropractic Research (PCCR)
William Beaumont Army Medical Center
United States Army Fort Bliss
Information provided by:
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT00632060
First received: February 29, 2008
Last updated: March 7, 2008
Last verified: February 2008
  Purpose

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

Condition Intervention
Low Back Pain
Procedure: Manual / Manipulative Therapy (M/MT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Decreased pain [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased function [ Time Frame: Baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Procedure: Manual / Manipulative Therapy (M/MT)
Subjects will receive M/MT twice a week for 4 weeks
Other Name: M/MT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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?"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632060

Contacts
Contact: Roxana Delgado, MS 915-569-3245/3245 roxana.delgado@amedd.army.mil
Contact: CPT Keith P Myers, MD 915-569-3245 keith.myers@amedd.army.mil

Locations
United States, Texas
Center for Integrative Medicine (CIM) at William Beaumont Army Medical Center; Soldier Family Medical Clinic (SFMC) at Ft. Bliss, TX Recruiting
El Paso, Texas, United States, 79920
Contact: Roxana Delgado, MS    915-569-2857    roxana.delgado@amedd.army.mil   
Principal Investigator: CPT Keith P Myers, MD         
Sub-Investigator: LTC Richard Petri, Jr., MD         
Sponsors and Collaborators
Samueli Institute for Information Biology
Palmer Center for Chiropractic Research (PCCR)
William Beaumont Army Medical Center
United States Army Fort Bliss
Investigators
Principal Investigator: CPT Keith P Myers, MD William Beaumont Army Medical Center
  More Information

No publications provided by Samueli Institute for Information Biology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CPT Keith P. Myers, MC / Chief, WBAMC Physical Medicine and Rehabilitation, William Beaumont Army Medical Center (WBAMC)
ClinicalTrials.gov Identifier: NCT00632060     History of Changes
Other Study ID Numbers: 1 EA-0000055, WBAMC #06/05; USUHS TX781-AX-2
Study First Received: February 29, 2008
Last Updated: March 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Samueli Institute for Information Biology:
Low Back Pain
Manual / Manipulative Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014