Osteopathic Treatment for Chronic Low Back Pain

NCT02983435 | Completed DMC

• 1 other identifier: rubens@unopar.br
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The relevance of this study is to determine the efficacy of two osteopathic techniques - Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few studies have investigated and compared the physiological responses of these techniques quantitatively, and no published study has compared their effects in low back pain subjects in terms of symptoms, postural balance and muscle activation. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed. This is the first study to compare these two osteopathic techniques using the main biological outcomes related to trunk neuromuscular function.

Conditions

Low Back Pain; Osteopathic Manipulative Treatment

Keywords

Osteopathic Treatment; Postural control; Neuromuscular activation; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Electromyography measurement - Root Mean Square (RMS)

  EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) will be computed to evaluate the back and abdominal activation during the functional task.

  Change from baseline muscular activation at 3 weeks, in both phases

Secondary Outcomes (2)

• Electromyography measurement - Median Frequency (MF)

  Change from baseline muscular activation at 3 weeks, in both phases

• Force platform measurement

  Change from baseline muscular activation at 3 weeks, in both phases

Other Outcomes (4)

• Visual Analogic Scale

  Change from baseline muscular activation at 3 weeks, in both phases

• Short Version of Pain Questionnaire McGill

  Change from baseline muscular activation at 3 weeks, in both phases

• Disability questionnaire

  Change from baseline muscular activation at 3 weeks, in both phases

Study Arms (2)

G1 - Thrust manipulation

EXPERIMENTAL

G1 - Thrust manipulation is an osteopathic technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).

Other: G1 - Thrust manipulation

G2 - Muscle Energy

ACTIVE COMPARATOR

G2 - Muscle Energy is a manual therapy technique based in muscular contraction and stretching. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.

Other: G2 - Muscle Energy

Interventions

G1 - Thrust manipulation OTHER

Osteopathic manipulation with Thrust technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).

G1 - Thrust manipulation

G2 - Muscle Energy OTHER

Osteopathic manipulation with Muscle Energy technique. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.

G2 - Muscle Energy

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic low back pain at least for three months.
• Low back pain of unknown mechanical origin without irradiation to the lower limbs.
• Workers with chronic low back pain at least three months.
• Do not be participating in rehabilitation programs.
• Do not have practiced regular physical activity in the past 3 months.

You may not qualify if:

• Manual therapy treatment in the past 90 days.
• Discal herniation diagnosis.
• Lumbar radiculopathy and / or nerve root compression.
• Lumbar stenosis.
• Lumbar surgery.
• Nerve root entrapment.
• Neurological and endocrine.
• Osteoporosis.
• Rheumatoid arthritis.
• Spinal osteomyelitis.
• Spondylolysis.
• Spondylolisthesis.
• Tumors.
• Vertebral fracture.
• No current sports or treatment in Physiotherapy, Pilates Method or Manual Therapy.

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Londrina, Paraná, 86041-120, Brazil

Location

Related Publications (6)

• Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.

  PMID: 23508598 BACKGROUND

• Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.

  PMID: 24139233 BACKGROUND

• Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.

  PMID: 21708042 BACKGROUND

• Cleland JA, Fritz JM, Childs JD, Kulig K. 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: study protocol of a randomized clinical trial [NCT00257998]. BMC Musculoskelet Disord. 2006 Feb 10;7:11. doi: 10.1186/1471-2474-7-11.

  PMID: 16472379 BACKGROUND

• da Silva RA Jr, Arsenault AB, Gravel D, Lariviere C, de Oliveira E Jr. Back muscle strength and fatigue in healthy and chronic low back pain subjects: a comparative study of 3 assessment protocols. Arch Phys Med Rehabil. 2005 Apr;86(4):722-9. doi: 10.1016/j.apmr.2004.08.007.

  PMID: 15827924 BACKGROUND

• Lariviere C, Gagnon D, Loisel P. The comparison of trunk muscles EMG activation between subjects with and without chronic low back pain during flexion-extension and lateral bending tasks. J Electromyogr Kinesiol. 2000 Apr;10(2):79-91. doi: 10.1016/s1050-6411(99)00027-9.

  PMID: 10699556 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Rubens da Silva, PhD

  Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)