Low Back PainNCT03550014

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

A study testing Low Back Only and Low Back+Hip in people with Low Back Pain and Hip Disease, run by Temple University at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain, Hip Disease
What is being tested?: Low Back Only and Low Back+Hip
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 7 sitesUnited States
Study dates: 2 Jul 2018to 14 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

BSR Physical Therapy
Barnegat, New Jersey, 08005
Kinetic Physical Therapy
Collegeville, Pennsylvania, 19426
Bellin Health Systems
Green Bay, Wisconsin, 54311
Franciscan Health Sports Medicine Physical Therapy Clinic
Indianapolis, Indiana, 46237
BSR Physical Therapy
Manahawkin, New Jersey, 08050
OSF St. Francis Medical Center
Peoria, Illinois, 61614
Temple University
Philadelphia, Pennsylvania, 19422

Other trials in United States

About this study

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

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).

Read the 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
Being tested: Low Back Only, Low Back+Hip
Keywords: Low Back Pain, Hip, Physical Therapy
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low Back OnlyProcedure or surgery
Also called standard physical therapy care
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+HipProcedure or surgery
Also called standard physical therapy care
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.

Study groups in NCT03550014
Study group	Role	What they receive
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. Receives: 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). Receives: Procedure: Low Back+Hip

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
The FABQ is a 16-item questionnaire designed to quantify fear and avoidance beliefs in patients with LBP. The FABQ has two sub-scales, a 7-item scale to measure fear-avoidance beliefs about work-related activities (FABQ-W) and a 4-item scale to measure fear-avoidance beliefs about physical activity (FABQ-PA). Each item is scored from 0-6 with possible scores ranging between 0-24 and 0-42 for the physical activity and work subscales, respectively, with higher scores representing increased fear-avoidance beliefs. Recent evidence suggests that the FABQ may be a valuable piece of data for predicting outcomes following intervention in work-related low back pain patients.
Measured: 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)
The GROC is a 15-point scale that ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). 28 Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. It has been reported that scores of +4 and +5 are indicative of moderate changes in patient status and scores of +6 and +7 indicate large changes in patient status. This scale will not be administered at baseline evaluation, but at all subsequent time points.
Measured: 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)
The PASS is a single question designed to determine if an individual considers their current status as 'feeling well'. The PASS question was: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" The participant response with a 'yes' or 'no' answer.
Measured: 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
The Godin-Shepard Leisure-Time Physical Activity Questionnaire allows for self-reported leisure-time physical activity. It allows the participant to designate the number of times per week that the engage in physical activities that are of varying intensities (strenuous, moderate, mild). The sum of each intensity is then multiplied by their corresponding metabolic equivalent values of 9, 5, and 3, respectively. High total scores provide the frequency and intensity of exercise that an individual participates in on a weekly basis. The questionnaire has been validated for classifying healthy adults into active and insufficiently active categories. A lack of physical activity in leisure times have been associated with increased prevalence of low back pain.
Measured: Baseline, end of intervention (discharge; an average of 6 weeks)
Patient Health Questionnaire-2 (PHQ-2)
The PHQ-2 is a validated two-question screening questionnaire that is used to determine the presence of depressive disorders. Individuals with low back pain that have depressive symptoms tend to have poor outcomes. The two questions are completed by the participant and scored on a 0-3 scale. The scores for both questions are summed with a cut off score of 3 or higher is considered more at risk for the presence of any depressive disorder.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201814 Jan 2021

First posted8 Jun 2018
Study start2 Jul 2018
Primary completion14 Jan 2020
Study completion14 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03550014
Sponsor's protocol ID: 24664
Status last verified: Mar 2021
First submitted: 15 May 2018
Last updated: 1 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: All data will be used as part of research project for dissertation purposes and not shared to other researchers

Publications

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.
PubMed 30217693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03550014
Acronym / sponsor ID: 24664
Conditions: Low Back Pain, Hip Disease
Keywords: Low Back Pain, Hip, Physical Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: University of Newcastle, Australia
Study start: 2 Jul 2018 (actual)
Primary completion: 14 Jan 2020 (actual)
Study completion: 14 Jan 2021 (actual)
First posted: 8 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Low Back Only	Active comparator	Procedure: Low Back OnlyParticipants randomized to the Low Back Only arm will receive physical therapy as directed by the treating physical therapist targeting the lower back.
Low Back+Hip	Active comparator	Procedure: Low Back+HipParticipants 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (20 listed)

Contraindications to manual therapy
Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
'Red flag' symptoms including:
Two or more positive neurologic signs consistent with nerve root compression:
Spinal surgery in the last 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low Back OnlyAlso: standard physical therapy careThe 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.	Procedure or surgery	Low Back Only
Low Back+HipAlso: standard physical therapy careThe 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.	Procedure or surgery	Low Back+Hip

Primary outcome

Change from baseline on the Modified Oswestry Disability Index (ODI)
Time frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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.
Change from baseline on the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
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.

5 secondary outcomes

Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline, end of intervention (discharge; an average of 6 weeks)
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Derived from this study: PubMed 30217693Burns 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.
Individual participant dataSharing planned: No. All data will be used as part of research project for dissertation purposes and not shared to other researchers

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott A Burns, DPT principal investigator

Temple University

Suzanne J Snodgrass, PhD study chair

The University of Newcastle

Darren A Rivett, PhD study director

The University of Newcastle

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low Back Only and Low Back+Hip in people with Low Back Pain and Hip Disease, run by Temple University at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline on the Modified Oswestry Disability Index (ODI) (time frame: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550014, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.