Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

NCT01765777 | Recruiting

• 1 other identifier: BHS-740
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the research study entitled "Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients with Chronic Lower Back Pain" is to investigate the hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and phototherapy will provide greater pain relief for patients with chronic lower back pain, as compared with standard medical management or either treatment alone.

Conditions

Chronic Lower Back Pain

Keywords

Low back pain; Lower back pain; Chronic back pain

Outcome Measures

Primary Outcomes (3)

• 10 cm visual analog scale for quantitative back pain

  VAS Data collected at all visits

  8 weeks

• SF-36 Health Survey to measure Quality of Life

  SF-36 survey data collected at 3 points

  8 weeks

• The Oswestry Back Questionnaire to measure qualitative back pain

  Oswestry questionnaire data collected at 3 points

  8 weeks

Study Arms (4)

Control Group

NO INTERVENTION

Subjects in this arm continue with standard medical care

Osteopathic Manipulative Medicine Group

EXPERIMENTAL

Subjects in this arm will receive an OMM intervention.

Procedure: Osteopathic Manipulative Medicine

Phototherapy Group

EXPERIMENTAL

Subjects in this arm will receive a phototherapy intervention.

Procedure: Phototherapy

OMM and Phototherapy Group

EXPERIMENTAL

Subjects in this arm will receive both the OMM and phototherapy interventions.

Procedure: Osteopathic Manipulative Medicine; Procedure: Phototherapy

Interventions

Osteopathic Manipulative Medicine PROCEDURE

Also known as: OMM,OMT

OMM and Phototherapy Group; Osteopathic Manipulative Medicine Group

Phototherapy PROCEDURE

Also known as: Low level laser therapy, LLLT

OMM and Phototherapy Group; Phototherapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18 - 65 years old
• Subjects with constant or intermittent nonspecific lower back pain for a minimum of three (3) months duration.

You may not qualify if:

• Prospective subjects with a diagnosis of the following potential underlying causes of lower back pain: ankylosing spondylitis, cancer or a history of a histologically demonstrated malignant carcinoma, cauda equine syndrome, herniated disc, spinal fracture, or spinal osteomyelitis.
• Prospective subjects who have undergone surgery of the lower back in the preceding three (3) months.
• Prospective subjects who have received worker's compensation in the preceding three (3) months, or are involved in litigation involving concerns of lower back.
• Prospective subjects who are pregnant.
• Prospective subjects who have been a patient receiving any osteopathic manipulative medicine (OMM) treatment at the clinical trial site in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
• Prospective subjects who have ever been an employee at the clinical trial site.
• Prospective subjects who have received spinal manipulation in the previous three (3) months, or on greater than three (3) occasions in the preceding year.
• Prospective subjects who are currently involved in a physical therapy rehabilitation program.
• Prospective subjects who have photosensitivity.

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

RECRUITING

Related Publications (32)

• Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of phototherapy in tissue repair. Photomed Laser Surg. 2009 Oct;27(5):695-702. doi: 10.1089/pho.2009.2550.

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• Licciardone JC. The unique role of osteopathic physicians in treating patients with low back pain. J Am Osteopath Assoc. 2004 Nov;104(11 Suppl 8):S13-8.

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• Nadler SF. Nonpharmacologic management of pain. J Am Osteopath Assoc. 2004 Nov;104(11 Suppl 8):S6-12.

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• Niemisto L, Sarna S, Lahtinen-Suopanki T, Lindgren KA, Hurri H. Predictive factors for 1-year outcome of chronic low back pain following manipulation, stabilizing exercises, and physician consultation or physician consultation alone. J Rehabil Med. 2004 May;36(3):104-9. doi: 10.1080/16501970310019151.

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• Tong HC, Heyman OG, Lado DA, Isser MM. Interexaminer reliability of three methods of combining test results to determine side of sacral restriction, sacral base position, and innominate bone position. J Am Osteopath Assoc. 2006 Aug;106(8):464-8.

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  PMID: 18723455 BACKGROUND

• Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.

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• Gamber R, Holland S, Russo DP, Cruser dA, Hilsenrath PE. Cost-effective osteopathic manipulative medicine: a literature review of cost-effectiveness analyses for osteopathic manipulative treatment. J Am Osteopath Assoc. 2005 Aug;105(8):357-67.

  PMID: 16166390 BACKGROUND

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• Licciardone JC, Russo DP. Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment. J Am Osteopath Assoc. 2006 Aug;106(8):457-63.

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• Mein EA, Greenman PE, McMillin DL, Richards DG, Nelson CD. Manual medicine diversity: research pitfalls and the emerging medical paradigm. J Am Osteopath Assoc. 2001 Aug;101(8):441-4.

  PMID: 11526876 BACKGROUND

• Navratil L, Kymplova J. Contraindications in noninvasive laser therapy: truth and fiction. J Clin Laser Med Surg. 2002 Dec;20(6):341-3. doi: 10.1089/104454702320901134.

  PMID: 12513921 BACKGROUND

• Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of laser phototherapy on pain relief. Clin J Pain. 2010 Oct;26(8):729-36. doi: 10.1097/AJP.0b013e3181f09713.

  PMID: 20842007 BACKGROUND

• Patterson, MM, PhD, Editorial - Research in OMT: What is the question and do we understand it?, JAOA, January 2007, Vol. 107, No. 1, pp. 8-11.

  BACKGROUND

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  BACKGROUND

• Task Force on the Low Back Pain Clinical Practice Guidelines. American Osteopathic Association Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients With Low Back Pain. J Am Osteopath Assoc. 2016 Aug 1;116(8):536-49. doi: 10.7556/jaoa.2016.107.

  PMID: 27455103 BACKGROUND

Related Links

• AHRQ - American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain

MeSH Terms

Conditions

Low Back Pain

Interventions

Phototherapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Laser Therapy

Study Officials

• Patricia S Kooyman, D.O.

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia S Kooyman, D.O.

CONTACT

516-686-1309; pkooyman@nyit.edu

Peter Douris, PT,DPT, EdD

CONTACT

516-686-7688; pdouris@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: June 1, 2011
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)