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Completed

NCT Number: NCT02476383

Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
  • Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
  • Appropriate for conservative treatment for low back pain.

Exclusion criteria

  • Non-English speaking;
  • Systemic medical conditions know to affect sensation (e.g. diabetes);
  • History of lumbar surgery or fracture within the past 6 months;
  • Received spinal manipulative therapy for treatment of low back pain within past 6 months;
  • Current or history of chronic pain condition other than low back pain

Treatment and study plan

Spinal Manipulative Therapy

Procedure

refer to arm descriptions

Primary outcomes

  1. numeric pain rating scale

    Time frame: Change in baseline at 2 weeks

    0 to 100 with 0= no pain at all to 100= worst pain imaginable

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: Change in baseline at 2 weeks

    0 to 100 with 0= no perceived disability to 100= greatest perceived disability

  2. Back Performance Scale

    Time frame: Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks

    0 to 15 with lower scores indicating better performance

  3. Quantitative Sensory Testing

    Time frame: change in baseline immediately following spinal manipulative therapy during day 1

    standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable

  4. Patient Centered Outcome Questionnaire

    Time frame: change in baseline immediately following spinal manipulative therapy during day 1

    Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale

  5. Working alliance subscale of the Pain Rehabilitation Expectation Scale

    Time frame: change in baseline immediately following spinal manipulative therapy during day 1

    Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance

  6. North American Spine Society Lumbar Spine Outcome Assessment

    Time frame: 2 weeks

    Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent

  7. Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale

    Time frame: 2 weeks

    a brief semi- structured interview

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2015
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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