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Low Back PainNCT02853357

Thoracic Spine Manipulation for Individuals With Low Back Pain

A study testing Manipulation and Core Strengthening Exercises in people with Low Back Pain, run by University of Michigan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Low Back Pain
What is being tested?
Manipulation and Core Strengthening Exercises
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
No sites listed yet
Study dates
31 Oct 2016to 30 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Short-term Effects of Thoracic Spine Thrust Manipulation for Individuals With Low Back Pain: A Randomized Control Trial

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.

Read the detailed description

This study aims to use a randomized controlled trial design to investigate the effects of thoracic spinal manipulation in conjunction with core strengthening exercises when compared to a sham manipulation and core strengthening exercises on patients with low back pain. Core strengthening exercises have been shown to improve pain and functional status in patients with non-specific low back pain when compared to conventional exercise. However, there is strong evidence to suggest that exercise alone is not adequate for the management of low back pain. Spinal manipulation has demonstrated promising results for the management of low back pain, but it is unclear whether the targeted location of manipulation is important. 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 based on the theory of regional interdependence. The specific aims of the study are as follows:

  1. To determine the effects of thoracic spine manipulation and core strengthening exercise on function in individuals with low back pain, specifically measured by changes in Modified Oswestry Low Back Pain Disability Questionnaire (MODQ).
  2. To determine the participant's perception of improvement following thoracic spine manipulation and core exercises, measured by global rating of change (GROC), when compared to a sham manipulation.
  3. To determine the effects of thoracic spine manipulation and core exercises on fear avoidance, measured by fear-avoidance belief questionnaire (FABQ), on individuals with low back pain.
  4. To determine the effects of thoracic spine manipulation and core exercises on pain using numeric pain rating scale (NPRS).

The ability to demonstrate the effectiveness of a manipulation targeted at the thoracic spine in conjunction with core exercises could provide clinicians a simple, effective treatment strategy for low back pain that not only has minimal injury risk, but has the potential to improve pain and function, ultimately decreasing the healthcare costs associated with low back pain.

The effects of treatment on disability, fear-avoidance, and pain will be analyzed using a 2x2 repeated measures multivariate analysis of variance (MANCOVA), with pre/post-test measures and time as the two factors and duration of symptoms serving as a covariate. An independent t test will be used to determine differences for the Global Rating of Change between groups at follow up, and the number needed to treat (NNT) will be calculated. Spinal manipulation has some potentially serious risks including, fracture, numbness, tingling, or injury to the spinal cord. However, these risks are very low in the thoracic spine where manipulation is targeted during this study. In a recent systematic review which evaluated the safety of thoracic spine manipulation, the authors found only seven cases of serious trauma which have resulted from thoracic spine manipulation. The majority of these cases were performed by a chiropractor and it is unsure whether participants had contraindications to manipulation. In order to mitigate these risks, participants will be thoroughly screened for contraindications to spinal manipulation. If an adverse event does occur, the participant will be referred to the appropriate provider and their participation in the study will be discontinued.

Conditions
Low Back Pain
Being tested
Manipulation, Sham Manipulation, Core Strengthening Exercises
Keywords
Thoracic manipulation, Low back pain, Core strengthening, Thoracic spine thrust manipulation
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ManipulationOther

    Also called Thoracic Manipulation, Thoracic spine thrust manipulation, Lower thoracic manipulation, Middle thoracic manipulation

    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.

  • Sham ManipulationOther

    Also called Sham thoracic manipulation

    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

  • Core Strengthening ExercisesOther

    Also called Transverse Abdominis exercises, Lumbar Multifidi exercises

    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.

Study groups in NCT02853357
Study groupRoleWhat they receive
ControlSham comparatorThe control group includes randomized participants that will receive a sham manipulation. Participants will also complete the standard set of core strengthening exercises.
Receives: Other: Sham Manipulation; Other: Core Strengthening Exercises
ManipulationExperimentalThe manipulation group includes randomized participants that will receive a thoracic spine thrust manipulation. Participants will also complete the standard set of core strengthening exercises.
Receives: Other: Manipulation; Other: Core Strengthening Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Change from Baseline on Numeric Pain Rating Scale (NPRS)

    An 11-point numeric pain rating scale will be used to assess pain before and after treatment. The scale ranges from 0 "no pain" to 10 "worst possible pain."

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

  2. Change from Baseline on Numeric Pain Rating Scale (NPRS)

    An 11-point numeric pain rating scale will be used to assess pain before and after treatment. The scale ranges from 0 "no pain" to 10 "worst possible pain."

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

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

    The FABQ is used to quantify individual's fear avoidance beliefs and LBP specifically regarding avoiding activity. The FABQ is divided into physical activity (FABQ-PA) and work subscales (FABQ-W) in which patients rate their agreement of each statement on a seven point Likert scale (0 is completely disagree and 6 is completely agree).

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

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

    The FABQ is used to quantify individual's fear avoidance beliefs and LBP specifically regarding avoiding activity. The FABQ is divided into physical activity (FABQ-PA) and work subscales (FABQ-W) in which patients rate their agreement of each statement on a seven point Likert scale (0 is completely disagree and 6 is completely agree).

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

  5. Global Rating of Change Scale (GROC)

    The GROC is used to assess self-perceived improvement of the intervention. The GROC is a 15-point scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better).

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

  6. Change on the Global Rating of Change Scale (GROC)

    The GROC is used to assess self-perceived improvement of the intervention. The GROC is a 15-point scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better).

    Measured: Administered at the final session (no more than 2 weeks after the initial evaluation) and 3 months after the final session

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2016 (estimated)
  2. Study start31 Oct 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02853357
Sponsor's protocol ID
HUM00105566
Status last verified
May 2018
First submitted
28 Jul 2016
Last updated
31 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23411647

  • 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.

    PubMed 25488399

  • 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.

    PubMed 19959652

  • 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.

    PubMed 22883130

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

  • 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.

  • 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.

    PubMed 22466247

  • 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.

    PubMed 23431209

  • 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.

    PubMed 23221367

  • 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.

    PubMed 21120303

  • 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.

    PubMed 20397032

Questions about this trial

What is this clinical trial studying?

A study testing Manipulation and Core Strengthening Exercises in people with Low Back Pain, run by University of Michigan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on Modified Oswestry Disability Questionnaire (MODQ) (time frame: Administered at the initial and final sessions (no more than 2 weeks apart)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02853357, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

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