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Completed

NCT Number: NCT03758807

A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

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Key information

Conditions

Low Back Pain Back Pain Education Manual Therapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kevin Farrell

Davenport, Iowa, 52803, United States

About this study

Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adults over the age of 18
  • patients presenting at PT with a primary complaint of LBP
  • LBP being present for 6 months or more
  • fluent in English
  • willing to participate in the study.

Exclusion criteria

  • under age 18
  • not able to read/understand the English language
  • prisoners
  • no medical issues precluding physical therapy treatment (red flags)
  • no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
  • prior spine surgery
  • unable to lay prone for the treatment

Treatment and study plan

Manual Therapy with Traditional Biomechanical Explanation

Other

Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..

Manual Therapy with Neuroplastiicity Explanation

Other

Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.

Primary outcomes

  1. Low Back Pain Rating

    Time frame: Change from baseline to initial treatment

    Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

    LBP is reported to be 2.0.

  2. Low Back Pain Rating

    Time frame: Change from initial treatment to 2-4 days

    Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

  3. Lumbar flexion

    Time frame: Change from baseline to initial treatment

    Active trunk forward flexion in cm (distance finger tips to floor)

  4. Lumbar flexion

    Time frame: Change from initial treatment to 2-4 days

    Active trunk forward flexion in cm (distance finger tips to floor)

  5. Straight Leg Raise

    Time frame: Change from baseline to initial treatment

    Neurodynamic Measurement of Leg Raise (lower limb tension test)

  6. Straight Leg Raise

    Time frame: Change from initial treatment to 2-4 days

    Neurodynamic Measurement of Leg Raise (lower limb tension test)

Sponsors and collaborators

Lead sponsor

St. Ambrose University

Other

Registry information

Official study title

A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Apr 23, 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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