A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain
Condition: Radiating Leg Pain; Disc Protrusion
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      Hypothesis - This study is designed to evaluate the results of using the Orthotrac Pneumatic
      Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion
      / herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic
      Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer
      progressions to surgery than those using the EZ form brace.
    

Detailed description: 
      Patient Inclusion / Exclusion Criteria:

      Patient's who present with low back and unilateral leg pain are potential candidates for
      recruitment in this study. For purposes of the research, leg pain will constitute symptoms
      extending down the leg beyond the knee. The contralateral side may have pain in the buttock
      and down the posterior thigh but not below the knee. The criteria are as follows:

      Inclusion / Exclusion:

        -  Age 21 - 55

        -  Preferred no prior surgery or no spine surgery in previous 6 months.

        -  No neurological deficit

        -  VAS > 4.0

        -  Symptoms unresolved after 4 weeks

        -  Minimal antalgic lean of the trunk when initially weight bearing

        -  Pain aggravated by weight bearing standing / walking

        -  Reduced leg pain on recumbency

        -  MRI Confirmed disc bulge / protrusion / herniation (HNP) site consistent with symptoms -
           preferred.

      Patient Recruitment:

      A total of 150 subjects, 75 per group, are being sought for this study. The best time to
      capture the list of potential patients is at the inception of their diagnosis and treatment.
      The TBI practice is equipped with electronic scheduling, medical record and billing systems.
      This poses significant advantages for patient recruitment to this project. On a daily basis,
      the project coordinator/patient recruiters (PC/PR) can access daily schedules for new
      patients entering the system for all 17 TBI physicians. This can be cross-correlated later
      with exiting diagnosis of leg pain to ensure maximum capture of potential candidates.

      Upon obtaining permission to solicit the patient, the project will be explained and signed
      informed consent obtained from patients who agree to participate. Non-participants will be
      solicited for signature to permit us to monitor their progress during the course of their
      treatment by administering the outcome questionnaires. Those whom do not sign consent to
      participate or consent to be monitored will continue with their care and be purged from the
      project records.

      Patient Randomization and Blinding of Analysis:

      At the inception of the project and prior to beginning patient recruitment, assignments for
      180 participants will be blocked randomized to obtain equal numbers in each treatment group;
      Orthotrac (OPV) and EZ form brace (EZF). An additional 30 randomizations over the study
      sample size of 150 will be completed to allow for 10% drop-out rate in each group in case of
      patient voluntary withdrawal from participation.

      Random assignments will be sealed in sequentially numbered envelopes and will be kept under
      lock in the office of the surgeon co-investigator . Upon patient signing of informed consent
      to participate, the project coordinator (PC / PR) will obtain the next consecutive sealed
      randomization envelope, assign the patient to the random group and deliver group assignment
      identification to the principal investigator (PI) for warehousing of recruitment data.

      The patient will then be scheduled with the PC who will obtain appropriate demographic
      information and administer the outcome measures. Measures will be obtained at the same time
      as recruitment when ever possible. Results from the outcome measures will be sealed in an
      envelope, unscored, and delivered to the surgeon co-investigator for warehousing and later
      analysis. In order to maintain blinding of the PC / PR, she will measure the patient and fit
      him/her for both devices on the initial visit. The PI will have the proper device ordered
      according to randomization and will check fitting on its delivery.

      Experimental Maneuver

      Patients who qualify for this study will have persistent leg pain attributed to lumbar HNP
      and be under typical medical / chiropractic care. At the stage of their entry into this
      project, the question of surgical intervention may be a realistic alternative. The
      experimental maneuver will contrast the ability of the OPV vs the EZF to improve symptoms and
      function. Patients assigned to the OPV group will be measured by the PC / PR and fit for the
      device. They will receive instructions in its use QID for a minimum of 30 minutes. Patients
      assigned to the EZF orthotic will be fit for the device and instructed to wear it during
      weight bearing hours.

      Patient Assessment and Outcome Measures:

      At the inception of the patient into the project, either as a participant or non-participant,
      a baseline assessment will be performed by the PC. Reassessment will be completed at 6, 12,
      26 and 52 weeks. The PC will monitor patient status and compliance with typical treatment on
      a weekly basis through the computerized scheduling and medical record. Telephone contact will
      be made on a biweekly basis to evaluate self-reported compliance with wear and determine any
      intervening health care service utilization or medication use using standardized phone
      interview methods

      Assessment measures will include the following:

        1. Inception baseline:

           a. Demographic b. Diagnostic c. Pre-episode work status d. Rang of Motion (ROM) i.
           Flexion / Extension ii. Straight leg raise e. Pain evaluation i. Pain levels (Visual
           analogue scale) ii. Quantitative pain drawing iii. Medication use f. Functional
           evaluation i. Oswestry Back Disability index ii. SF - 36

        2. Follow-up evaluations:

             1. Work status

             2. Rang of Motion (ROM)

           i. Flexion / Extension ii. Straight leg raise c. Pain evaluation i. Pain levels (Visual
           analogue scale) ii. Quantitative pain drawing iii. Medication use d. Functional
           evaluation i. Oswestry Back Disability index ii. SF - 36

        3. Bi-weekly telephone contacts

             1. Work status

             2. Medication use

             3. Wear compliance

             4. Other health care utilization

             5. TBI treatment sessions (PT, DC, MD, injections, surgical scheduling)

      Primary outcome for this project will be quantitative pain levels, using the VAS. Monitoring
      of medication use is expected to support this outcome. Further primary outcome centering on
      functionality scores will focus on the Oswestry and SF 36. The SF36 results can be expected
      to be a useful adjunct in the assessment of patients with low back pain when combined with
      disease-specific questionnaires (3). All other measures will be used descriptively and as
      explanatory variables.
    

Intervention name(s): Orthotrac Pneumatic Vest
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Randomized controlled clinical trial