A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- St. Ambrose University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Straight Leg Raise
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients were randomly assigned to one of two treatment groups
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Passive treatment
Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.
Intervention: Manual Therapy with Traditional Biomechanical Explanation (Other)
Active Treatment
Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.
Intervention: Manual Therapy with Neuroplastiicity Explanation (Other)
Outcomes
Primary Outcomes
Straight Leg Raise
Time Frame: Change from initial treatment to 2-4 days
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Lumbar flexion
Time Frame: Change from initial treatment to 2-4 days
Active trunk forward flexion in cm (distance finger tips to floor)
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.
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.
Lumbar flexion
Time Frame: Change from baseline to initial treatment
Active trunk forward flexion in cm (distance finger tips to floor)
Straight Leg Raise
Time Frame: Change from baseline to initial treatment
Neurodynamic Measurement of Leg Raise (lower limb tension test)
Secondary Outcomes
No secondary outcomes reported
Investigators
Kevin Farrell
Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy
St. Ambrose University