Sub-acute and Chronic Back-related Leg PainNCT00494065
Chiropractic and Self-care for Back-Related Leg Pain
A study testing Home exercise and Chiropractic Spinal Manipulative Therapy + Home exercise in people with Sub-acute and Chronic Back-related Leg Pain, run by Northwestern Health Sciences University at 2 sites in United States.
Trial summary
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sub-acute and Chronic Back-related Leg Pain
- What is being tested?
- Home exercise and Chiropractic Spinal Manipulative Therapy + Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Oct 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Back-related leg pain > 3 on 0 to 10 scale.
- Sub-acute or chronic back-related leg pain defined as current episode > 4 weeks duration.
- Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root.
- 21 years of age and older.
- Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).
Who cannot join
- Ongoing treatment for leg or low back pain by other health care providers.
- Progressive neurological deficits or cauda equina syndrome.
- QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
- QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
- Uncontrolled hypertension or metabolic disease.
- Blood clotting disorders.
Show all 11Show fewer
- Severe osteoporosis.
- Inflammatory or destructive tissue changes of the spine.
- Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of low back pain patients which generally have a poorer prognosis.
- Pregnant or nursing women.
- Current or pending litigation. Patients seeking financial compensation tend to respond differently to treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Health Sciences University
Bloomington, Minnesota, 55337
Palmer Center for Chiropractic Research
Davenport, Iowa, 52803
About this study
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.
Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
- Being tested
- Home exercise, Chiropractic Spinal Manipulative Therapy + Home exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exerciseOther
Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.
Chiropractic Spinal Manipulative Therapy + Home exerciseOther
The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chiropractic Spinal Manipulative Therapy + Home exercise Receives: Other: Chiropractic Spinal Manipulative Therapy + Home exercise |
| 2 | Active comparator | Home exercise Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated leg pain
Measured: short-term = 12 weeks; long-term = 52 weeks
Secondary outcomes (9)
Bothersomeness
Measured: short-term = 12 weeks; long-term = 52 weeks
Frequency
Measured: short-term = 12 weeks; long-term = 52 weeks
Disability
Measured: short-term = 12 weeks; long-term = 52 weeks
General Health Status
Measured: short-term = 12 weeks; long-term = 52 weeks
Fear Avoidance
Measured: short-term = 12 weeks; long-term = 52 weeks
Patient Satisfaction
Measured: short-term = 12 weeks; long-term = 52 weeks
Improvement
Measured: short-term = 12 weeks; long-term = 52 weeks
Medication Use
Measured: short-term = 12 weeks; long-term = 52 weeks
Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance
Measured: short-term = 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sub-acute and Chronic Back-related Leg 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Gert Bronfort, DC, PhD, Principal investigator, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494065
- Sponsor's protocol ID
- R18HP07638
- Other IDs
- R18HP07638
- Status last verified
- Jan 2014
- First submitted
- 27 Jun 2007
- Last updated
- 31 Jan 2014
- Results posted
- No
Publications
Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014 Sep 16;161(6):381-91. doi: 10.7326/M14-0006.
PubMed 25222385Schulz CA, Hondras MA, Evans RL, Gudavalli MR, Long CR, Owens EF, Wilder DG, Bronfort G. Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8.
PubMed 21426558
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic and Self-care for Back-Related Leg Pain
- ClinicalTrials.gov ID
- NCT00494065
- Acronym / sponsor ID
- R18HP07638
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Northwestern Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jun 2007 (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.
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.
Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Chiropractic Spinal Manipulative Therapy + Home exerciseChiropractic Spinal Manipulative Therapy + Home exercise |
| 2 | Active comparator | Other: Home exerciseHome exercise |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Back-related leg pain > 3 on 0 to 10 scale.
- Sub-acute or chronic back-related leg pain defined as current episode > 4 weeks duration.
- Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root.
- 21 years of age and older.
- Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).
Key exclusion criteria (11 listed)
- Ongoing treatment for leg or low back pain by other health care providers.
- Progressive neurological deficits or cauda equina syndrome.
- QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
- QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
- Uncontrolled hypertension or metabolic disease.
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 |
|---|---|---|
| Home exercisePatient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions. | Other | 2 |
| Chiropractic Spinal Manipulative Therapy + Home exerciseThe number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization. | Other | 1 |
Primary outcome
Patient-rated leg pain
Time frame: short-term = 12 weeks; long-term = 52 weeks
9 secondary outcomes
Bothersomeness
Time frame: short-term = 12 weeks; long-term = 52 weeks
Frequency
Time frame: short-term = 12 weeks; long-term = 52 weeks
Disability
Time frame: short-term = 12 weeks; long-term = 52 weeks
General Health Status
Time frame: short-term = 12 weeks; long-term = 52 weeks
Fear Avoidance
Time frame: short-term = 12 weeks; long-term = 52 weeks
Patient Satisfaction
Time frame: short-term = 12 weeks; long-term = 52 weeks
Improvement
Time frame: short-term = 12 weeks; long-term = 52 weeks
Medication Use
Time frame: short-term = 12 weeks; long-term = 52 weeks
Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance
Time frame: short-term = 12 weeks
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 31 Jan 2014.
- Derived from this study: PubMed 25222385Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014 Sep 16;161(6):381-91. doi: 10.7326/M14-0006.
- Derived from this study: PubMed 21426558Schulz CA, Hondras MA, Evans RL, Gudavalli MR, Long CR, Owens EF, Wilder DG, Bronfort G. Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8.
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.
Gert Bronfort, DC, PhD principal investigator
Northwestern Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise and Chiropractic Spinal Manipulative Therapy + Home exercise in people with Sub-acute and Chronic Back-related Leg Pain, run by Northwestern Health Sciences University at 2 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 5 inclusion and 11 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 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Patient-rated leg pain (time frame: short-term = 12 weeks; long-term = 52 weeks). 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 NCT00494065, which also lists 2 linked publications.
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 31 Jan 2014.