Low Back PainNCT02170753
Regional Manual Therapy and Motor Control Exercise for Chronic Low Back Pain
A study testing Regional manual therapy and Standard physical therapy in people with Low Back Pain and Musculoskeletal Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Purpose: The primary purpose of this study is to determine whether or not the addition of thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach consisting of motor control exercises and lumbar spine manual therapy is better than standard PT alone at improving thoracolumbar spine range… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Musculoskeletal Pain
- What is being tested?
- Regional manual therapy and Standard physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 65
- have an active complaint of non-specific low back pain for at least three months
- demonstrate hypomobility of the thoracic or lumbar regions on at least one spinal level
- demonstrate at least two of the following unilateral or bilateral hip ROM deficits: hip flexion < 110°, hip extension loss > 6°, or hip rotation < 30° internally or externally
- demonstrate any one of the following: pain that worsens with sustained end- range movements or positions, lumbar hypermobility, diminished trunk or pelvic muscle strength and endurance, or movement coordination impairments during community/work activities
- Modified Oswestry Score ≥ 30%
Who cannot join
- evidence of red flags, including fracture, infection, spinal tumor, or cauda equina syndrome
- pain that can be centralized through repeated movements
- signs of hyporeflexia, hypoesthesia, and myotomal weakness indicative of nerve root compression
- pregnancy
- systemic inflammatory conditions such as rheumatoid arthritis or ankylosing spondylitis
- inability to safely tolerate manual therapy to the spine or hips
- injections to the low back within the 2 weeks preceding the initial evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Professions Physical Therapy Clinic
Dallas, Texas, 75390-8876
About this study
Official title: Regional Manual Therapy and Motor Control Exercise for the Management of Chronic Low Back Pain With Hip and Spine Motion Loss: A Randomized Clinical Trial
Purpose: The primary purpose of this study is to determine whether or not the addition of thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach consisting of motor control exercises and lumbar spine manual therapy is better than standard PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity, disability level, and perceived change in patients with chronic low back pain (CLBP) and movement coordination impairments.
Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity, physical disability level, and perceived change at two, four, and 12 weeks after initiating treatment.
Read the detailed description
This study will use a 2x4 factorial mixed design with a between-factor independent variable (IV) of group and a within-factor IV of time. The dependent variables include hip ROM, segmental mobility of the thoracolumbar spine, pain, disability level, and patients' perceived rating of change (GROC). Hip ROM and spinal mobility variables will be measured by the researchers, while pain, disability level, and GROC score will be measured by self-reported questionnaires.
The experimental group will receive a motor control exercise program and manual therapy to the hips and spine corresponding to the individual's unique mobility impairments. The comparison group will receive a motor control exercise program and manual therapy to the lumbar spine only. Both groups will receive treatments at an outpatient clinic 2 times a week for 4 weeks. All outcome measures will be collected at baseline (except the GROC), and then at two weeks, four weeks, and twelve weeks after beginning treatment.
All study participants will receive a motor control exercise program consistent with standard of care. Exercises will be targeted to the abdominals, hip flexors, back extensors, hip extensors, hip flexors, hip abductors, and hip adductors, but will begin with those muscles that test weakest in the clinical exam. Generally, exercises for each subject begin with isolated isometric contractions to ensure adequate motor control, and progress through various degrees of agonist loading with co-contraction of synergists using isotonic open or closed chain movements. Instructions to gradually increase time under tension to a maximum of 30 seconds for four repetitions will be used in order to provide an element of graded-activity exposure and to reflect the tonic nature of stabilizing muscles. Participants unable to complete all exercises by the end of the fourth week will be instructed on how to progress to the final exercises with their independent home exercise program.
In addition to a motor control exercise program, all participants will receive manual therapy to the lumbar spine. Standard PT manual therapy will be limited to non-thrust passive accessory (PA) mobilizations from L1-L5 or soft tissue mobilization to the lumbar paraspinals or quadratus lumborum. Only the participants in the experimental group will receive manual therapy to the hips and thoracic spine according to the mobility impairments identified during the initial testing session. The manual therapy interventions utilized at the hips and thoracic spine are considered standard of care for treatment of those regions, but could be considered experimental for treatment of low back pain. Regional manual therapy will include a variety of thrust and non-thrust techniques targeting the thoracic, lumbopelvic, or hip joints. Hip-based techniques including anterior-posterior hip mobilization, caudal thrust or non-thrust mobilization, and posterior-to-anterior mobilization will be performed. The choice of initiating or suspending a specific manual therapy technique and the grade of treatment will be left to the discretion of the treating therapist (other than the PI). Prior to the commencement of the study, all treating physical therapists will be trained in administration of standard motor control exercises and manual therapy.
- Conditions
- Low Back Pain, Musculoskeletal Pain
- Being tested
- Regional manual therapy, Standard physical therapy
- Medical subject headings
- Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional manual therapyProcedure or surgery
The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy.
Standard physical therapyProcedure or surgery
The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Regional manual therapy | Experimental | The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy Receives: Procedure: Regional manual therapy; Procedure: Standard physical therapy |
| Standard physical therapy | Active comparator | The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy. Receives: Procedure: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability level
A subjective report of the participant's average level of perceived disability with functional tasks due to LBP as measured by the Modified Oswestry Low Back Pain Disability Questionnaire (ODQ).
Measured: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Secondary outcomes (4)
Change in Thoracolumbar spine range of motion
Testing for this study will be performed using the Valedo Shape, which is a wheeled skin-surface device containing accelerometers that record inter-segmental distance and change of inclination of spinous processes.
Measured: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Hip range of motion
An inclinometer will be used to measure hip range of motion in the sagittal and transverse planes as measured in degrees.
Measured: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Pain intensity
A subjective report of the participant's average low back pain intensity over the previous 24 hours as measured by the Numeric Pain Rating Scale (NPRS).
Measured: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Perceived change
A subjective report of the participant's perceived level of improvement from the point that they began treatment as measured by the Global Rating of Change (GROC) scale.
Measured: 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Responsible party
- Sponsor
- Investigators
- Jason A Zafereo, MPT, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170753
- Sponsor's protocol ID
- STU 042014-066
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2014
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Manual Therapy and Motor Control Exercise for the Management of Chronic Low Back Pain With Hip and Spine Motion Loss: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02170753
- Acronym / sponsor ID
- STU 042014-066
- Conditions
- Low Back Pain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- 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.
Purpose: The primary purpose of this study is to determine whether or not the addition of thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach consisting of motor control exercises and lumbar spine manual therapy is better than standard PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity, disability level, and perceived change in patients with chronic low back pain (CLBP) and movement coordination impairments.
Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity, physical disability level, and perceived change at two, four, and 12 weeks after initiating treatment.
Detailed description
This study will use a 2x4 factorial mixed design with a between-factor independent variable (IV) of group and a within-factor IV of time. The dependent variables include hip ROM, segmental mobility of the thoracolumbar spine, pain, disability level, and patients' perceived rating of change (GROC). Hip ROM and spinal mobility variables will be measured by the researchers, while pain, disability level, and GROC score will be measured by self-reported questionnaires.
The experimental group will receive a motor control exercise program and manual therapy to the hips and spine corresponding to the individual's unique mobility impairments. The comparison group will receive a motor control exercise program and manual therapy to the lumbar spine only. Both groups will receive treatments at an outpatient clinic 2 times a week for 4 weeks. All outcome measures will be collected at baseline (except the GROC), and then at two weeks, four weeks, and twelve weeks after beginning treatment.
All study participants will receive a motor control exercise program consistent with standard of care. Exercises will be targeted to the abdominals, hip flexors, back extensors, hip extensors, hip flexors, hip abductors, and hip adductors, but will begin with those muscles that test weakest in the clinical exam. Generally, exercises for each subject begin with isolated isometric contractions to ensure adequate motor control, and progress through various degrees of agonist loading with co-contraction of synergists using isotonic open or closed chain movements. Instructions to gradually increase time under tension to a maximum of 30 seconds for four repetitions will be used in order to provide an element of graded-activity exposure and to reflect the tonic nature of stabilizing muscles. Participants unable to complete all exercises by the end of the fourth week will be instructed on how to progress to the final exercises with their independent home exercise program.
In addition to a motor control exercise program, all participants will receive manual therapy to the lumbar spine. Standard PT manual therapy will be limited to non-thrust passive accessory (PA) mobilizations from L1-L5 or soft tissue mobilization to the lumbar paraspinals or quadratus lumborum. Only the participants in the experimental group will receive manual therapy to the hips and thoracic spine according to the mobility impairments identified during the initial testing session. The manual therapy interventions utilized at the hips and thoracic spine are considered standard of care for treatment of those regions, but could be considered experimental for treatment of low back pain. Regional manual therapy will include a variety of thrust and non-thrust techniques targeting the thoracic, lumbopelvic, or hip joints. Hip-based techniques including anterior-posterior hip mobilization, caudal thrust or non-thrust mobilization, and posterior-to-anterior mobilization will be performed. The choice of initiating or suspending a specific manual therapy technique and the grade of treatment will be left to the discretion of the treating therapist (other than the PI). Prior to the commencement of the study, all treating physical therapists will be trained in administration of standard motor control exercises and manual therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional manual therapy | Experimental | Procedure: Regional manual therapy, Procedure: Standard physical therapyThe experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy |
| Standard physical therapy | Active comparator | Procedure: Standard physical therapyThe control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between the ages of 18 and 65
- have an active complaint of non-specific low back pain for at least three months
- demonstrate hypomobility of the thoracic or lumbar regions on at least one spinal level
- demonstrate at least two of the following unilateral or bilateral hip ROM deficits: hip flexion < 110°, hip extension loss > 6°, or hip rotation < 30° internally or externally
- demonstrate any one of the following: pain that worsens with sustained end- range movements or positions, lumbar hypermobility, diminished trunk or pelvic muscle strength and endurance, or movement coordination impairments during community/work activities
Key exclusion criteria (7 listed)
- evidence of red flags, including fracture, infection, spinal tumor, or cauda equina syndrome
- pain that can be centralized through repeated movements
- signs of hyporeflexia, hypoesthesia, and myotomal weakness indicative of nerve root compression
- pregnancy
- systemic inflammatory conditions such as rheumatoid arthritis or ankylosing spondylitis
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 |
|---|---|---|
| Regional manual therapyThe experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy. | Procedure or surgery | Regional manual therapy |
| Standard physical therapyThe control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy. | Procedure or surgery | Regional manual therapy, Standard physical therapy |
Primary outcome
Change in Disability level
Time frame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
A subjective report of the participant's average level of perceived disability with functional tasks due to LBP as measured by the Modified Oswestry Low Back Pain Disability Questionnaire (ODQ).
4 secondary outcomes
Change in Thoracolumbar spine range of motion
Time frame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Hip range of motion
Time frame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Pain intensity
Time frame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment
Change in Perceived change
Time frame: 2 weeks, 4 weeks, and 12 weeks after beginning treatment
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 27 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Jason A Zafereo, MPT principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional manual therapy and Standard physical therapy in people with Low Back Pain and Musculoskeletal Pain, run by University of Texas Southwestern Medical Center at 1 site 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 6 inclusion and 7 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in Disability level (time frame: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2016.