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Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents

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ClinicalTrials.gov Identifier: NCT02111278
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital

Brief 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 patients with low back pain who would benefit from lumbar manipulation.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Lumbar Manipulation Other: Sham Manipulation Other: Physical Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: lumbar Manipulation
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.
Other: Lumbar Manipulation
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.

Other: Physical Therapy
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.

Placebo Comparator: Sham Manipulation
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.
Other: Sham Manipulation
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.

Other: Physical Therapy
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Global Rating of Change scale [ Time Frame: 1 week, and 4 weeks ]
    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.

  2. Change in Numeric Pain Rating Scale [ Time Frame: Initial Evaluation, 1 week, 4 weeks, and 6 month ]
    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.


Other Outcome Measures:
  1. Recurrence of low back pain [ Time Frame: 6 months ]
    Patients will be asked if they have had significant pain or a recurrence of pain in the low back since therapy has ended. Yes or No response from the patient.

  2. Sought further treatment [ Time Frame: 6 months ]
    Patient will be asked if they sought further treatment for their low back pain after 4 weeks of physical therapy ended.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients 13 to 17 years old
  • duration of low back symptoms less than 90 days

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111278


Locations
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United States, Ohio
Nationwide Children's Hospital Sports and Ortho PT Ortho Center
Columbus, Ohio, United States, 43205
Nationwide Children's Hospital Sports and Ortho PT East Broad
Columbus, Ohio, United States, 43213
Nationwide Children's Hospital Sports and Ortho PT Westerville
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Mitchell C Selhorst, DPT Nationwide Children's Hospital
Publications:

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Responsible Party: Mitchell Selhorst, Research Coordinator, Sports and Orthopedic Physical Therapy Department, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02111278    
Other Study ID Numbers: IRB11-00262
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Mitchell Selhorst, Nationwide Children's Hospital:
Manipulation
Lumbar
Low Back Pain
Manual Therapy
Adolescents
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations