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Completed

NCT Number: NCT00257998

Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain

Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain that are likely to benefit from a lumbo-pelvic manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result in the same outcome.Purpose: The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rehabilitation Services of Concord Hospital

Concord, New Hampshire, 03301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity
  • Oswestry disability score of at least 25%
  • Age greater than 18 years and less than 60 years
  • At least four out of five of the following criteria:
  • Duration of current episode < 16 days (judged from the patient's self-report)
  • No symptoms extending distal to the knee (judged from the pain diagram)
  • FABQ-W score <19
  • At least one hip with >350 internal rotation range of motion (measured in prone)
  • Stiffness in the lumbar spine (judged from segmental mobility testing)

Exclusion criteria

  • Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  • Signs consistent with nerve root compression, this includes any one of the following:
  • Reproduction of low back or leg pain with straight leg raise at less than 450
  • Muscle weakness involving a major muscle group of the lower extremity
  • Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
  • Diminished or absent sensation to pinprick in any lower extremity dermatome
  • Prior surgery to the lumbar spine or buttock
  • Current pregnancy
  • Past medical history of osteoporosis or spinal compression fracture
  • Inability to comply with treatment schedule (weekly sessions for four weeks)

Treatment and study plan

Mobilization

Procedure

manualtherapy techniques

Primary outcomes

  1. The Oswestry Disability Index, which will serve as the primary outcome measure.

    Time frame: 4 weeks, 6 months

Sponsors and collaborators

Lead sponsor

Franklin Pierce University

Other

Collaborators

  • University of Southern California

Registry information

Official study title

Comparison of the Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain Who Satisfy a Clinical Prediction Rule: A Randomized Clinical Trial.

Important dates

Study start
2005
Study completion
2007
First posted
Nov 24, 2005
Registry last updated
Nov 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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