Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips

NCT03550014 | Completed

• 1 other identifier: 24664
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 7

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).

Conditions

Low Back Pain; Hip Disease

Keywords

Low Back Pain; Hip; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline on the Modified Oswestry Disability Index (ODI)

  The ODI is a reliable and responsive 10 question condition-specific self-report measure for individuals with LBP. The ODI is scored on a scale from 0% to 100%, higher scores indicating higher levels of disability.

  Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

• Change from baseline on the Numeric Pain Rating Scale (NPRS)

  The NPRS is an 11 point scale (0-10) where the participant is asked to rate their pain intensity at best, worst and average over the last 24 hours. The scale is anchored on the left (score of 0) with the phrase "No Pain" and on the right (score of 10) with the phrase "Worst Imaginable Pain". The NPRS is a valid and reliable assessment of pain severity for individuals with low back pain.

  Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

Secondary Outcomes (5)

• Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)

  Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

• Change from baseline on the Global Rating of Change (GROC)

  2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

• Change from baseline on the Patient Acceptable Symptom State (PASS)

  2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months

• Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire

  Baseline, end of intervention (discharge; an average of 6 weeks)

• Patient Health Questionnaire-2 (PHQ-2)

  Baseline

Study Arms (2)

Low Back Only

ACTIVE COMPARATOR

Participants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back.

Procedure: Low Back Only

Low Back+Hip

ACTIVE COMPARATOR

Participants randomized to the Low Back+Hip arm will receive physical therapy as directed by the treating physical therapist targeting the lower back. In addition to that treatment, participants will received hands-on and exercise physical therapy interventions directed at the hip(s).

Procedure: Low Back+Hip

Interventions

Low Back Only PROCEDURE

The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will only be directed at the lower back. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.

Also known as: standard physical therapy care

Low Back Only

Low Back+Hip PROCEDURE

The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will be directed at the lower back and the hips. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.

Also known as: standard physical therapy care

Low Back+Hip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• University of Newcastle, Australia: collaborator

Study Sites (7)

OSF St. Francis Medical Center

Peoria, Illinois, 61614, United States

Location

Franciscan Health Sports Medicine Physical Therapy Clinic

Indianapolis, Indiana, 46237, United States

Location

BSR Physical Therapy

Barnegat, New Jersey, 08005, United States

Location

BSR Physical Therapy

Manahawkin, New Jersey, 08050, United States

Location

Kinetic Physical Therapy

Collegeville, Pennsylvania, 19426, United States

Location

Temple University

Philadelphia, Pennsylvania, 19422, United States

Location

Bellin Health Systems

Green Bay, Wisconsin, 54311, United States

Location

Related Publications (1)

• 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.

  PMID: 30217693 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott A Burns, DPT

  Temple University

  PRINCIPAL INVESTIGATOR

• Suzanne J Snodgrass, PhD

  The University of Newcastle

  STUDY CHAIR

• Darren A Rivett, PhD

  The University of Newcastle

  STUDY DIRECTOR

• Joshua A Cleland, DPT, PhD

  Franklin Pierce University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 8, 2018
• Study Start: July 2, 2018
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)