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

NCT ID: NCT03550014

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2021-01-14

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.

Conditions

Low Back Pain; Hip Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Back Only

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

Group Type: ACTIVE_COMPARATOR

Low Back Only

Intervention Type: 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.

Low Back+Hip

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).

Group Type: ACTIVE_COMPARATOR

Low Back+Hip

Intervention Type: 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.

Interventions

Low Back Only

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.

Intervention Type: PROCEDURE

Low Back+Hip

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.

Intervention Type: PROCEDURE

Other Intervention Names

standard physical therapy care; standard physical therapy care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Newcastle, Australia

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott A Burns, DPT

Role: PRINCIPAL_INVESTIGATOR

Temple University

Suzanne J Snodgrass, PhD

Role: STUDY_CHAIR

The University of Newcastle

Darren A Rivett, PhD

Role: STUDY_DIRECTOR

The University of Newcastle

Joshua A Cleland, DPT, PhD

Role: STUDY_DIRECTOR

Franklin Pierce University

Locations

OSF St. Francis Medical Center

Peoria, Illinois, United States

Franciscan Health Sports Medicine Physical Therapy Clinic

Indianapolis, Indiana, United States

BSR Physical Therapy

Barnegat, New Jersey, United States

BSR Physical Therapy

Manahawkin, New Jersey, United States

Kinetic Physical Therapy

Collegeville, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Bellin Health Systems

Green Bay, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30217693 (View on PubMed)

Other Identifiers

24664

Identifier Type: -

Identifier Source: org_study_id