Recruiting
Phase 2

Manual Therapy

Sponsor:

University of North Texas Health Science Center

Code:

NCT00394264

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 17 - 35

Healthy Volunteers: Not accepted

Interventions

Soft Tissue

Myofascial release

Counterstrain

Muscle energy

Sacro-iliac articulation

Study Details

Brief summary:

Musculoskeletal injuries including low back pain (LBP) are a major problem in military personnel. These injuries can result from training exercises, job duties, or recreational activities. However incurred, many of these injuries can result in limited duty in work or training, and can decrease military readiness.

The National Osteopathic Research Center (ORC) will examine the effectiveness of a specific set of Osteopathic Manipulative Treatment interventions referred to as Manual/Manipulative Therapy (M/MT) to reduce pain and improve functioning in young active duty military personnel.

The broad overall goal of this proposed research project is to determine the feasibility of conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring full performance in military personnel in the operational environment. A second goal is to estimate the treatment effect size of M/MT in this population.

The following two hypotheses will guide the data study:

  • Hypothesis 1: Subjects receiving manual/manipulative therapy for low back pain will report less pain at two and four weeks than subjects in the control group.
  • Hypothesis 2: Subjects receiving manual/manipulative therapy for low back pain will achieve greater functioning at two and four weeks than subjects in the control group.

Conditions

Low Back Pain

Study ID

NCT00394264

Start date

Oct, 2006

Status verified date

Oct, 2006

Completion date

Oct, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active duty military personnel
  • Male and Female
  • Age range 17-35
  • Present with a new episode of low back pain (may be acute or new episode of chronic)

Exclusion Criteria:

  • Pregnancy
  • Any serious neurological, rheumatological, or orthopedic conditions such as spondylolysis, spondylolithesis,fracture, nerve impingement, tumors, or infections.
  • Prior manipulative treatment for this episode LBP.
  • Leg pain worse than back pain indicating possible radiculopathy.
  • Clinical evidence of a leg length discrepancy greater than 13mm.
  • Inability to give informed consent.
  • Inability to follow course of care for four weeks.

Study Design

Enrollment

100 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Soft Tissue

Myofascial release

Counterstrain

Muscle energy

Sacro-iliac articulation

High-velocity, low amplitude

Primary outcome measure

  • Pain [ Time Frame: undefined ]
  • Functionality [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

des Anges Cruser, Ph.D., MPA

817-735-2009dcruser@hsc.unt.edu

Locations

Madigan Army Medical Center

Recruiting

Fort Lewis, Washington, United States, 98431

Contacts

Douglas M Maurer, D.O.

253-968-3127Douglas.Maurer@us.army.mil

Nancy Allison

253-968-4647nancy.allison@us.army.mil

Principal Investigator:

Douglas M Maurer, D.O.

More Information

Sponsor

University of North Texas Health Science Center

Last update posted

Oct 31, 2006

Last verified

Oct, 2006

Keywords

  • low back pain
  • active duty military personnel
  • manual/manipulative therapy
  • osteopathic manipulative treatment
  • physical medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Texas Health Science Center on 2006-10-31.