Thoracic Spine Manipulation for Individuals With Low Back Pain

NCT02853357 | Completed DMC

• 1 other identifier: HUM00105566
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the short-term effects of thoracic spine thrust manipulation on participants with low back pain. Participants in this study will be randomized to receive either the lower thoracic spinal manipulation and a standard set of exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized that thoracic manipulation when combined with core strengthening exercises will have positive short term improvements in pain and function for patients with LBP as compared to a sham manipulation combined with core strengthening exercises.

Conditions

Low Back Pain

Keywords

Thoracic manipulation; Low back pain; Core strengthening; Thoracic spine thrust manipulation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ)

  The MODQ is a functional scale assessing the impact of low back pain on daily activities by assigning a disability score according to the answered questions. The scale includes 10 questions regard the level of pain and interference with several physical activities including: sleeping, lifting, travelling, self-care, and social life. Each question has six possible responses (scored from 0 to 5), and patients are asked to pick the one that most accurately responds to their condition. The sum of the response is divided by the total possible score and multiplied by 100 to receive a percentage of disability with 0% corresponding to no disability and 100% corresponding to a great deal of disability.

  Administered at the initial and final sessions (no more than 2 weeks apart)

Secondary Outcomes (7)

• Change from Baseline on Numeric Pain Rating Scale (NPRS)

  Administered at the initial and final sessions (no more than 2 weeks apart)

• Change from Baseline on Numeric Pain Rating Scale (NPRS)

  Administered at the initial session and 3 months after the final session

• Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ)

  Administered at the initial and final sessions (no more than 2 weeks apart)

• Change from Baseline on Fear-Avoidance Belief Questionnaire (FABQ)

  Administered at the initial session and 3 months after the final session

• Global Rating of Change Scale (GROC)

  Administered at the final session (no more than 2 weeks after the initial evaluation)

Study Arms (2)

Control

SHAM COMPARATOR

The control group includes randomized participants that will receive a sham manipulation. Participants will also complete the standard set of core strengthening exercises.

Other: Sham Manipulation; Other: Core Strengthening Exercises

Manipulation

EXPERIMENTAL

The manipulation group includes randomized participants that will receive a thoracic spine thrust manipulation. Participants will also complete the standard set of core strengthening exercises.

Other: Manipulation; Other: Core Strengthening Exercises

Interventions

Manipulation OTHER

Middle Thoracic: Participants are placed in the supine position with their arms over their chest. The clinician rolls the participant to their side and places the fulcrum at the desired thoracic segment and the participant is rolled back onto the clinician's hand. The participant is instructed to take a deep breath. As the participant is exhaling, the clinician uses his body to push through the participant's arms to perform a high velocity thrust in an anterior to posterior directed force. Lower Thoracic: With the patient in a prone position, the clinician achieves a "skin lock" with both pisiforms over the transverse processes of the target vertebra. The clinician then uses his body to push down through his arms to perform a high-velocity, low-amplitude posterior to anterior thrust.

Also known as: Thoracic Manipulation, Thoracic spine thrust manipulation, Lower thoracic manipulation, Middle thoracic manipulation

Manipulation

Sham Manipulation OTHER

The participants are positioned in prone and the clinician's hands are placed with the pisiforms of each hand over the transverse processes of the target vertebra. The clinician will only apply minimal pressure and slide the hands across the skin to mimic the manipulative thrust. This sham procedure has been shown to be an adequate sham comparator for spinal manipulative therapy (SMT) with similar expectations and believability as SMT active treatment

Also known as: Sham thoracic manipulation

Control

Core Strengthening Exercises OTHER

Both groups will receive the following exercises at each visit. The core strengthening (core strengthening) exercises are a standard protocol used by Richardson et al and Franca et al which are proposed to target muscles responsible for segmental stabilization, specifically the transverse abdominis (TrA) and the lumbar multifidi (LM). Exercises will include: TrA exercises in 4 point kneeling and in supine with flexed knee, LM exercises in prone, and co-contraction of TrA and LM in upright position. Three sets of 15 repetitions will be done for each exercise.

Also known as: Transverse Abdominis exercises, Lumbar Multifidi exercises

Control; Manipulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A certain minimum pain intensity score on an 11-point numeric pain rating scale (ranging from 0-10 points)
• A certain minimum disability rain on the Modified Oswestry Disability Questionnaire
• Individuals who have received a prescription for physical therapy for low back pain

You may not qualify if:

• Contraindications to spinal manipulation such as osteoporosis, active cancer, previous spinal surgery, spinal fracture, acute rheumatic disease, active tuberculosis, pregnancy, active infections of the vertebra or intervertebral disc, any neurological evidence suggesting compromise of the nerve roots or spinal cord (changes in myotomal strength, deep tendon reflexes, or sensation), or cauda equina syndrome
• Insufficient English skills to complete questionnaires
• Are involved in litigation or a workman's compensation claim

Sponsors & Collaborators

• University of Michigan: lead
• Rocky Mountain University of Health Professions: collaborator

Related Publications (11)

• Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.

  PMID: 23411647 BACKGROUND

• Smith BE, Littlewood C, May S. An update of stabilisation exercises for low back pain: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2014 Dec 9;15:416. doi: 10.1186/1471-2474-15-416.

  PMID: 25488399 BACKGROUND

• Mintken PE, Cleland JA, Carpenter KJ, Bieniek ML, Keirns M, Whitman JM. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010 Jan;90(1):26-42. doi: 10.2522/ptj.20090095. Epub 2009 Dec 3.

  PMID: 19959652 BACKGROUND

• Michener LA, Kardouni JR, Lopes Albers AD, Ely JM. Development of a sham comparator for thoracic spinal manipulative therapy for use with shoulder disorders. Man Ther. 2013 Feb;18(1):60-4. doi: 10.1016/j.math.2012.07.003. Epub 2012 Aug 9.

  PMID: 22883130 BACKGROUND

• Richardson C, Hodges P, Hides J. Therapeutic exercise for lumbopelvic stabilization. Churchill Livingstone London; 2004.

  BACKGROUND

• Richardson CA, Jull G, Hodges P, Hides J. Therapeutic exercise for spinal segmental stabilization in low back pain: scientific basis and clinical approach. Churchill Livingstone; 1999.

  BACKGROUND

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 RESULT

• de Oliveira RF, Liebano RE, Costa Lda C, Rissato LL, Costa LO. Immediate effects of region-specific and non-region-specific spinal manipulative therapy in patients with chronic low back pain: a randomized controlled trial. Phys Ther. 2013 Jun;93(6):748-56. doi: 10.2522/ptj.20120256. Epub 2013 Feb 21.

  PMID: 23431209 RESULT

• Masaracchio M, Cleland JA, Hellman M, Hagins M. Short-term combined effects of thoracic spine thrust manipulation and cervical spine nonthrust manipulation in individuals with mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2013 Mar;43(3):118-27. doi: 10.2519/jospt.2013.4221. Epub 2012 Dec 7.

  PMID: 23221367 RESULT

• Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.

  PMID: 21120303 RESULT

• Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17.

  PMID: 20397032 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Fisher, BS, DPT, OCS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 2, 2016
• Study Start: October 31, 2016
• Primary Completion: April 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share