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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03758807
Other study ID # StAmbroseUactive passive
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date December 30, 2018

Study information

Verified date November 2018
Source St. Ambrose University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual Therapy with Traditional Biomechanical Explanation
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
Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.

Locations

Country Name City State
United States Kevin Farrell Davenport Iowa

Sponsors (1)

Lead Sponsor Collaborator
St. Ambrose University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.10 — View Citation

Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.

Outcome

Type Measure Description Time frame Safety issue
Primary Low Back Pain Rating 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.
Change from baseline to initial treatment
Primary Low Back Pain Rating 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. Change from initial treatment to 2-4 days
Primary Lumbar flexion Active trunk forward flexion in cm (distance finger tips to floor) Change from baseline to initial treatment
Primary Lumbar flexion Active trunk forward flexion in cm (distance finger tips to floor) Change from initial treatment to 2-4 days
Primary Straight Leg Raise Neurodynamic Measurement of Leg Raise (lower limb tension test) Change from baseline to initial treatment
Primary Straight Leg Raise Neurodynamic Measurement of Leg Raise (lower limb tension test) Change from initial treatment to 2-4 days
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