Low Back PainNCT02111278
Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents
A study testing Lumbar Manipulation and Physical Therapy in people with Low Back Pain, run by Nationwide Children's Hospital at 3 sites in United States.
Trial summary
The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar Manipulation and Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Dec 2014
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients 13 to 17 years old
- duration of low back symptoms less than 90 days
Who cannot join
- contraindication to manipulation. These included "red flags" for physical therapy, previous lumbar surgery, those who had signs consistent with nerve root compression (positive straight-leg test of < 45 degrees, diminished reflexes, sensation, or lower extremity strength), those who were pregnant, and those diagnosed with, or suspected of having a spondylolysis or spondylolisthesis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nationwide Children's Hospital Sports and Ortho PT Ortho Center
Columbus, Ohio, 43205
Nationwide Children's Hospital Sports and Ortho PT East Broad
Columbus, Ohio, 43213
Nationwide Children's Hospital Sports and Ortho PT Westerville
Westerville, Ohio, 43082
About this study
Official title: Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial
The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.
Read the detailed description
This is a double blind, randomized controlled, parallel group study. The investigators will consider adolescent patients with a primary complaint of low back pain referred to physical therapy.
The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.
Prior to randomization, patients will complete several self-report measures and then receive a standardized history and physical examination performed by the treating physical therapist. The information collected will include age, sex, duration and nature of symptoms. Standardized physical examination measures include lumbar active range of motion assessment for quality and mobility, lumbar segmental mobility, hip internal rotation range of motion, straight leg raise test, and prone instability test. Treating physical therapists were trained in all evaluation measures before data collection began. Patients are assessed on each item of a modified clinical prediction rule which consists of 4 items; duration of symptoms, symptoms distal to knee, Hip Internal Rotation >35 degrees, and presence of lumbar segmental hypomobility. The fear avoidance beliefs questionnaire work sub-scale component was removed since the score would likely not be valid in the adolescent population. Meeting 3 of the 4 items was considered to be positive on the rule in this population.
The manipulating therapist who performs the intervention will be aware of treatment allocation, whereas the treating physical therapist and patients are blinded to treatment group allocation. To assess if the patients are successfully blinded to group allocation, the investigator will ask each patient to guess which intervention was performed on them following discharge from therapy.
Randomization is determined by checking a randomly generated computer list that tells the manipulating therapist the assigned group. The computer list was generated by an aide not involved in the study who blindly drew 52 cards that placed an equal number of patients into either the manipulation or sham group.
To address the issue of safety, patients who experience a clinically significant decrease in functional ability or increase in pain will be classified as having an adverse reaction. The minimally clinical important difference for the Patient Specific Functional Scale is >= 6. While the minimal clinical important difference of the Numeric Pain Rating Scale is 2 points. Following the manipulation or sham intervention patients will be asked if they experienced pain or discomfort during or following the intervention. An interim analysis is planned at the midpoint of the study to assess the safety and efficacy of the intervention. If >1/3 of patients in the manipulation group have a worsening of symptoms at any follow up, the study will be terminated for safety reasons.
- Conditions
- Low Back Pain
- Being tested
- Lumbar Manipulation, Sham Manipulation, Physical Therapy
- Keywords
- Manipulation, Lumbar, Low Back Pain, Manual Therapy, Adolescents
- 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.
Lumbar ManipulationOther
The manipulating therapist performs the lumbar manipulation technique. With the patient supine, the therapist stands opposite the side to be manipulated. The patient is passively side-bent away from the therapist. The therapist rotates the thoracic spine and then delivers a quick posterior and inferior thrust through the anterior superior iliac spine. The manipulation is performed on the side the patient reported to be more symptomatic. If the patient is unable to identify a more painful side, the side to be manipulated is left to the manipulating therapist discretion. If a cavitation is experienced, no more manipulations are performed that session. If no cavitation is produced, the patient is repositioned, and the manipulation is attempted again. If no cavitation is experienced again, the therapist attempts to manipulate the opposite side. A maximum of two attempts per side will be attempted.
Sham ManipulationOther
The manipulating therapist will perform the sham lumbar manipulation technique with the patient side-lying. The therapist passively flexes both hips until slight lumbar flexion is noted at the patient's most painful vertebral level. The therapist will take time palpating patient's spine taking care to avoid rotating the spine. The therapist will then place both hands on the same lumbar spinous process. An equal and opposite force is then applied to the spinous process with both hands. No physiologic motion is expected with this technique. The patient will then be setup for the same sham technique on the opposite side. The sham manipulation technique will be performed in an attempt to blind the patient to group allocation. This technique is designed to provide similar hands on treatment time as the manipulation intervention.
Physical TherapyOther
Patients will receive 4 weeks of physical therapy with 2 visits per week. The treating physical therapist is blinded to group allocation. The treating physical therapist will prescribe exercises based on patient presentation. Therapy visits last approximately 45-60 minutes depending of patient ability to perform exercises. The treating physical therapist will perform no mobilizations or manipulations on the patient.
| Study group | Role | What they receive |
|---|---|---|
| lumbar Manipulation | Experimental | Patients randomized to this treatment group will receive lumbar manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week. Receives: Other: Lumbar Manipulation; Other: Physical Therapy |
| Sham Manipulation | Placebo comparator | Patients randomized to this treatment group will receive a sham manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week. Receives: Other: Sham Manipulation; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Specific Functional Scale
The Patient Specific Functional scale asks the participant to nominate 3 important activities they are not able to do or are having difficulty performing because of their back pain. Each activity is scored on a numerical rating scale from 0 (unable to perform) to 10 (able to perform at pre-injury level).
Measured: Initial Evaluation, 1 week, 4 weeks, and 6 month
Secondary outcomes (2)
Global Rating of Change scale
The Global Rating of Change scale is a 15-point Likert type scale (-7 to +7). A score of 0 represents no change from initial injury, +7 represents a great deal better, and -7 represents a great deal worse.
Measured: 1 week, and 4 weeks
Change in Numeric Pain Rating Scale
The Numeric Pain Rating Scale is an 11-point pain-rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) to assess current pain intensity and the best and worst level of pain during the last 24 hours. An average of the 3 ratings will be used.
Measured: Initial Evaluation, 1 week, 4 weeks, and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Selhorst, Nationwide Children's Hospital
- Investigators
- Mitchell C Selhorst, DPT, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111278
- Sponsor's protocol ID
- IRB11-00262
- Status last verified
- Dec 2014
- First submitted
- 9 Apr 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaughn DW, Kenyon LK, Sobeck CM, Smith RE. Spinal manual therapy interventions for pediatric patients: a systematic review. J Man Manip Ther. 2012 Aug;20(3):153-9. doi: 10.1179/2042618612Y.0000000007.
PubMed 23904755Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
PubMed 22466247Ndetan H, Evans MW Jr, Hawk C, Walker C. Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey. J Altern Complement Med. 2012 Apr;18(4):347-53. doi: 10.1089/acm.2011.0268. Epub 2012 Mar 2.
PubMed 22384933Koppenhaver SL, Fritz JM, Hebert JJ, Kawchuk GN, Childs JD, Parent EC, Gill NW, Teyhen DS. Association between changes in abdominal and lumbar multifidus muscle thickness and clinical improvement after spinal manipulation. J Orthop Sports Phys Ther. 2011 Jun;41(6):389-99. doi: 10.2519/jospt.2011.3632. Epub 2011 Apr 6.
PubMed 21471653Vela LI, Haladay DE, Denegar C. Clinical assessment of low-back-pain treatment outcomes in athletes. J Sport Rehabil. 2011 Feb;20(1):74-88. doi: 10.1123/jsr.20.1.74.
PubMed 21411824Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011 May;91(5):675-88. doi: 10.2522/ptj.20100229. Epub 2011 Mar 3.
PubMed 21372203Fritz JM, Koppenhaver SL, Kawchuk GN, Teyhen DS, Hebert JJ, Childs JD. Preliminary investigation of the mechanisms underlying the effects of manipulation: exploration of a multivariate model including spinal stiffness, multifidus recruitment, and clinical findings. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1772-81. doi: 10.1097/BRS.0b013e318216337d.
PubMed 21358568Stanton TR, Fritz JM, Hancock MJ, Latimer J, Maher CG, Wand BM, Parent EC. Evaluation of a treatment-based classification algorithm for low back pain: a cross-sectional study. Phys Ther. 2011 Apr;91(4):496-509. doi: 10.2522/ptj.20100272. Epub 2011 Feb 17.
PubMed 21330450Hall AM, Maher CG, Latimer J, Ferreira ML, Costa LO. The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. Eur Spine J. 2011 Jan;20(1):79-86. doi: 10.1007/s00586-010-1521-8. Epub 2010 Jul 14.
PubMed 20628767Humphreys BK. Possible adverse events in children treated by manual therapy: a review. Chiropr Osteopat. 2010 Jun 2;18:12. doi: 10.1186/1746-1340-18-12.
PubMed 20525194Fritz JM, Clifford SN. Low back pain in adolescents: a comparison of clinical outcomes in sports participants and nonparticipants. J Athl Train. 2010 Jan-Feb;45(1):61-6. doi: 10.4085/1062-6050-45.1.61.
PubMed 20064050Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PubMed 19027342Resnik L, Liu D, Mor V, Hart DL. Predictors of physical therapy clinic performance in the treatment of patients with low back pain syndromes. Phys Ther. 2008 Sep;88(9):989-1004. doi: 10.2522/ptj.20070110. Epub 2008 Aug 8.
PubMed 18689610Chen KC, Chiu EH. Adolescent idiopathic scoliosis treated by spinal manipulation: a case study. J Altern Complement Med. 2008 Jul;14(6):749-51. doi: 10.1089/acm.2008.0054.
PubMed 18673077Vohra S, Johnston BC, Cramer K, Humphreys K. Adverse events associated with pediatric spinal manipulation: a systematic review. Pediatrics. 2007 Jan;119(1):e275-83. doi: 10.1542/peds.2006-1392. Epub 2006 Dec 18.
PubMed 17178922
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02111278
- Acronym / sponsor ID
- IRB11-00262
- Conditions
- Low Back Pain
- Keywords
- Manipulation, Lumbar, Low Back Pain, Manual Therapy, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 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.
The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.
Detailed description
This is a double blind, randomized controlled, parallel group study. The investigators will consider adolescent patients with a primary complaint of low back pain referred to physical therapy.
The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.
Prior to randomization, patients will complete several self-report measures and then receive a standardized history and physical examination performed by the treating physical therapist. The information collected will include age, sex, duration and nature of symptoms. Standardized physical examination measures include lumbar active range of motion assessment for quality and mobility, lumbar segmental mobility, hip internal rotation range of motion, straight leg raise test, and prone instability test. Treating physical therapists were trained in all evaluation measures before data collection began. Patients are assessed on each item of a modified clinical prediction rule which consists of 4 items; duration of symptoms, symptoms distal to knee, Hip Internal Rotation >35 degrees, and presence of lumbar segmental hypomobility. The fear avoidance beliefs questionnaire work sub-scale component was removed since the score would likely not be valid in the adolescent population. Meeting 3 of the 4 items was considered to be positive on the rule in this population.
The manipulating therapist who performs the intervention will be aware of treatment allocation, whereas the treating physical therapist and patients are blinded to treatment group allocation. To assess if the patients are successfully blinded to group allocation, the investigator will ask each patient to guess which intervention was performed on them following discharge from therapy.
Randomization is determined by checking a randomly generated computer list that tells the manipulating therapist the assigned group. The computer list was generated by an aide not involved in the study who blindly drew 52 cards that placed an equal number of patients into either the manipulation or sham group.
To address the issue of safety, patients who experience a clinically significant decrease in functional ability or increase in pain will be classified as having an adverse reaction. The minimally clinical important difference for the Patient Specific Functional Scale is >= 6. While the minimal clinical important difference of the Numeric Pain Rating Scale is 2 points. Following the manipulation or sham intervention patients will be asked if they experienced pain or discomfort during or following the intervention. An interim analysis is planned at the midpoint of the study to assess the safety and efficacy of the intervention. If >1/3 of patients in the manipulation group have a worsening of symptoms at any follow up, the study will be terminated for safety reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar Manipulation | Experimental | Other: Lumbar Manipulation, Other: Physical TherapyPatients randomized to this treatment group will receive lumbar manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week. |
| Sham Manipulation | Placebo comparator | Other: Sham Manipulation, Other: Physical TherapyPatients randomized to this treatment group will receive a sham manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients 13 to 17 years old
- duration of low back symptoms less than 90 days
Key exclusion criteria (1 listed)
- contraindication to manipulation. These included "red flags" for physical therapy, previous lumbar surgery, those who had signs consistent with nerve root compression (positive straight-leg test of < 45 degrees, diminished reflexes, sensation, or lower extremity strength), those who were pregnant, and those diagnosed with, or suspected of having a spondylolysis or spondylolisthesis.
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 |
|---|---|---|
| Lumbar ManipulationThe manipulating therapist performs the lumbar manipulation technique. With the patient supine, the therapist stands opposite the side to be manipulated. The patient is passively side-bent away from the therapist. The therapist rotates the thoracic spine and then delivers a quick posterior and inferior thrust through the anterior superior iliac spine. The manipulation is performed on the side the patient reported to be more symptomatic. If the patient is unable to identify a more painful side, the side to be manipulated is left to the manipulating therapist discretion. If a cavitation is experienced, no more manipulations are performed that session. If no cavitation is produced, the patient is repositioned, and the manipulation is attempted again. If no cavitation is experienced again, the therapist attempts to manipulate the opposite side. A maximum of two attempts per side will be attempted. | Other | lumbar Manipulation |
| Sham ManipulationThe manipulating therapist will perform the sham lumbar manipulation technique with the patient side-lying. The therapist passively flexes both hips until slight lumbar flexion is noted at the patient's most painful vertebral level. The therapist will take time palpating patient's spine taking care to avoid rotating the spine. The therapist will then place both hands on the same lumbar spinous process. An equal and opposite force is then applied to the spinous process with both hands. No physiologic motion is expected with this technique. The patient will then be setup for the same sham technique on the opposite side. The sham manipulation technique will be performed in an attempt to blind the patient to group allocation. This technique is designed to provide similar hands on treatment time as the manipulation intervention. | Other | Sham Manipulation |
| Physical TherapyPatients will receive 4 weeks of physical therapy with 2 visits per week. The treating physical therapist is blinded to group allocation. The treating physical therapist will prescribe exercises based on patient presentation. Therapy visits last approximately 45-60 minutes depending of patient ability to perform exercises. The treating physical therapist will perform no mobilizations or manipulations on the patient. | Other | Sham Manipulation, lumbar Manipulation |
Primary outcome
Change in Patient Specific Functional Scale
Time frame: Initial Evaluation, 1 week, 4 weeks, and 6 month
The Patient Specific Functional scale asks the participant to nominate 3 important activities they are not able to do or are having difficulty performing because of their back pain. Each activity is scored on a numerical rating scale from 0 (unable to perform) to 10 (able to perform at pre-injury level).
2 secondary outcomes
Global Rating of Change scale
Time frame: 1 week, and 4 weeks
Change in Numeric Pain Rating Scale
Time frame: Initial Evaluation, 1 week, 4 weeks, and 6 month
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 23 Dec 2014.
- Background: PubMed 23904755Vaughn DW, Kenyon LK, Sobeck CM, Smith RE. Spinal manual therapy interventions for pediatric patients: a systematic review. J Man Manip Ther. 2012 Aug;20(3):153-9. doi: 10.1179/2042618612Y.0000000007.
- Background: PubMed 22466247Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
- Background: PubMed 22384933Ndetan H, Evans MW Jr, Hawk C, Walker C. Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey. J Altern Complement Med. 2012 Apr;18(4):347-53. doi: 10.1089/acm.2011.0268. Epub 2012 Mar 2.
- Background: PubMed 21471653Koppenhaver SL, Fritz JM, Hebert JJ, Kawchuk GN, Childs JD, Parent EC, Gill NW, Teyhen DS. Association between changes in abdominal and lumbar multifidus muscle thickness and clinical improvement after spinal manipulation. J Orthop Sports Phys Ther. 2011 Jun;41(6):389-99. doi: 10.2519/jospt.2011.3632. Epub 2011 Apr 6.
- Background: PubMed 21411824Vela LI, Haladay DE, Denegar C. Clinical assessment of low-back-pain treatment outcomes in athletes. J Sport Rehabil. 2011 Feb;20(1):74-88. doi: 10.1123/jsr.20.1.74.
- Background: PubMed 21372203Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011 May;91(5):675-88. doi: 10.2522/ptj.20100229. Epub 2011 Mar 3.
- Background: PubMed 21358568Fritz JM, Koppenhaver SL, Kawchuk GN, Teyhen DS, Hebert JJ, Childs JD. Preliminary investigation of the mechanisms underlying the effects of manipulation: exploration of a multivariate model including spinal stiffness, multifidus recruitment, and clinical findings. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1772-81. doi: 10.1097/BRS.0b013e318216337d.
- Background: PubMed 21330450Stanton TR, Fritz JM, Hancock MJ, Latimer J, Maher CG, Wand BM, Parent EC. Evaluation of a treatment-based classification algorithm for low back pain: a cross-sectional study. Phys Ther. 2011 Apr;91(4):496-509. doi: 10.2522/ptj.20100272. Epub 2011 Feb 17.
- Background: PubMed 20628767Hall AM, Maher CG, Latimer J, Ferreira ML, Costa LO. The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. Eur Spine J. 2011 Jan;20(1):79-86. doi: 10.1007/s00586-010-1521-8. Epub 2010 Jul 14.
- Background: PubMed 20525194Humphreys BK. Possible adverse events in children treated by manual therapy: a review. Chiropr Osteopat. 2010 Jun 2;18:12. doi: 10.1186/1746-1340-18-12.
- Background: PubMed 20064050Fritz JM, Clifford SN. Low back pain in adolescents: a comparison of clinical outcomes in sports participants and nonparticipants. J Athl Train. 2010 Jan-Feb;45(1):61-6. doi: 10.4085/1062-6050-45.1.61.
- Background: PubMed 19027342Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
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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.
Mitchell C Selhorst, DPT principal investigator
Nationwide Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Manipulation and Physical Therapy in people with Low Back Pain, run by Nationwide Children's Hospital at 3 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 2 inclusion and 1 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 Patient Specific Functional Scale (time frame: Initial Evaluation, 1 week, 4 weeks, and 6 month). 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 NCT02111278, which also lists 24 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 23 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.