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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758807
• Other study ID #: StAmbroseUactive passive
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Education
• Low Back Pain
• Manual Therapy

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