Chiropractic Manipulation and Medical Care for Low Back Pain

NCT ID: NCT01211613

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-10-31

Brief Summary

The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Manipulation

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Group Type: EXPERIMENTAL

Manual Manipulation

Intervention Type: PROCEDURE

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Mechanical Manipulation

Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.

Group Type: EXPERIMENTAL

Mechanically-assisted manipulation

Intervention Type: DEVICE

Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.

Standard Medical Care

Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Group Type: ACTIVE_COMPARATOR

Standard Medical Care

Intervention Type: OTHER

Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Interventions

Manual Manipulation

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Intervention Type: PROCEDURE

Mechanically-assisted manipulation

Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.

Intervention Type: DEVICE

Standard Medical Care

Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

Intervention Type: OTHER

Other Intervention Names

Activator IV Instrument: FDA approval# K003185

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 18 years of age
• Ability to read and write English
• Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
• Oswestry Disability Index score between 20-70 points (0-100 scale)
• Numeric pain rating score between 3-8 points (0-10 scale)

Exclusion Criteria

• Prior history of lumbar spine surgery
• History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
• Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
• History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
• Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
• Receiving any on-going medical care for this episode of low back pain
• Current use of opiate or other prescription medications for low back pain

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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Michael Schneider, DC, PhD

DC, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Schneider, PhD, DC

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center: Center for Integrative Medicine

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010.

Reference Type: BACKGROUND

PMID: 20350672 (View on PubMed)

Tonelli Enrico V, Schneider M, Haas M, Vo N, Huang W, McFarland C, Weber N, Sowa G. The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1059. doi: 10.1186/s12891-022-06027-9.

Reference Type: DERIVED

PMID: 36471334 (View on PubMed)

Other Identifiers

4R00AT004196-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO10040327

Identifier Type: -

Identifier Source: org_study_id