Clinical trial NCT03550014: Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips
Official title: The Effect of Physical Therapy Interventions Directed at the Low Back Versus Low Back and Hips for Individuals With a Primary Complaint of Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Hip Disease
Keywords: Low Back Pain
Hip
Physical Therapy
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: University of Newcastle, Australia
First posted: 2018-06-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to have receive physical therapy targeting the low back only or low back plus hip(s). Neither the participants or investigators can be blinded during this trial.
Primary purpose: TREATMENT

Brief summary: Low back pain (LBP) is the leading cause of disability worldwide and has substantial impacts on pain and function for an individual. Some individuals with LBP seek physical therapy for their condition. The purpose of the study is to determine whether individuals with LBP have improved pain and disability following physical therapy targeting either the low back only or low back plus hip(s).

Detailed description: Often, individuals with LBP also have concurrent impairments in strength and/or range of motion of one or both hips. Physical therapists may or may not decide to treat the concurrent hip impairments for an individual with LBP based on their clinical decision making. Currently, it is unknown which approach leads to superior patient outcomes in terms of pain and disability.

Eligibility criteria: Inclusion Criteria:

* Modified Oswestry Disability Index (ODI) ≥ 20%
* Numeric Pain Rating Scale (NPRS) of ≥ 2 points
* Primary complaint of low back pain with at least one hip impairment in one or both hips

Exclusion Criteria:

* Contraindications to manual therapy
* Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
* 'Red flag' symptoms including:

  * Tumor
  * Metabolic disease
  * Rheumatoid arthritis or other systemic rheumatologic disorders
  * Acute fracture
  * Bowel/Bladder dysfunction
  * Prolonged history of corticosteroid use
  * Evidence of central nervous system involvement
* Two or more positive neurologic signs consistent with nerve root compression:

  * Diminished muscle stretch reflexes of lower extremity
  * Muscle weakness in any lower extremity myotome
  * Diminished or absent sensation in any lower extremity dermatome
* Spinal surgery in the last 6 months
* Total Hip Arthroplasty
* Currently pregnant or post-partum ≤ 6 months
* Osteoporosis
* History of cancer within the last 12 months
* Inability to understand the English language

Primary outcomes:
measure: Change from baseline on the Modified Oswestry Disability Index (ODI)
timeFrame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
measure: Change from baseline on the Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
Secondary outcomes:
measure: Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
measure: Change from baseline on the Global Rating of Change (GROC)
timeFrame: 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
measure: Change from baseline on the Patient Acceptable Symptom State (PASS)
timeFrame: 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
measure: Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire
timeFrame: Baseline, end of intervention (discharge; an average of 6 weeks)
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Sports Medicine Physical Therapy Clinic
state: Indiana
city: Barnegat
country: United States
facility: BSR Physical Therapy
state: New Jersey
city: Manahawkin
country: United States
facility: BSR Physical Therapy
state: New Jersey
city: Collegeville
country: United States
facility: Kinetic Physical Therapy
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Green Bay
country: United States
facility: Bellin Health Systems
state: Wisconsin
Study officials:
affiliation: Temple University
name: Scott A Burns, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Newcastle
name: Suzanne J Snodgrass, PhD
role: STUDY_CHAIR
affiliation: The University of Newcastle
name: Darren A Rivett, PhD
role: STUDY_DIRECTOR
affiliation: Franklin Pierce University
name: Joshua A Cleland, DPT, PhD
role: STUDY_DIRECTOR
References:
citation: Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.