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Compare between insoles versus insoles placebo in treatment of back pain, A systematic review of ran

Discussion in 'Biomechanics, Sports and Foot orthoses' started by foofoo, Nov 19, 2009.

  1. foofoo

    foofoo Welcome New Poster

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    hi, i'm student in last year of physical therapy ,i need your help in the first my research ,can you help me to make good Literature .

    Problem: emergence of rumors of the importance of wearing insole shoes in the descending case of back pain in our community and So far this is still studying in college effectiveness of it.

    Q_ Can putting a simple pair of insoles inside your shoes to treat back pain?

    Title: compare between insoles versus insoles placebo in treatment of back pain, A systematic review of randomized controlled trials.

    Ho: there is relationship between insoles and back pain in treatment
    HA: there is no relationship between insoles and back pain in effective treatment.
    Study design: A systematic review of randomized controlled trials, single blind.
    Variable: 1_dependent: nonspecific back pain, pain intensity: Visual Analogue Rating scale (VAS); duration of back pain; absenteeism;
    Functional Status Questionnaire.
    2_independent: insoles versus insoles placebo
    Outcome measure: diagnosis of back pain; pain intensity: Visual Analogue Rating scale (VAS); duration of back pain; absenteeism;
    Functional Status Questionnaire (look at attach)
    Rational: To determine the effectiveness of shoe insoles in treatment of nonspecific back pain compared with placebo, no intervention, or other interventions. Especially for Community awareness Including the prevailing wear of insoles, Is it really treat for BP or not?.

    Sample: sample size 100, Confidence Level: 95%, effect size of group A n=60 and in group B n=40
    Demographic: age: 30+-5 years, Gender: female
    Anthropometric: height :( 153_165) cm, Wight (50_66) kg, BMI (18.5 - 24.99) kg/m2
    Exclusion criteria: include a history of trauma, fever, incontinence, unexplained weight loss, a cancer history, long-term steroid use(red flags), no history of back pain, gender male, above 35 year or below 25 years, more or less this Wight (50_66)kg , more or less BMI(18.9_42.99) kg/m2
    Inclusion criteria: gender Female, age (25_35), height (153_165), Wight (50_66)kg , BMI (18.9_42.99) kg/m2 ,nonspecific back pain, occupation: nurses.

    Background: There is lack of theoretical and clinical knowledge of the use of insoles for treatment of back pain.

    Procedure: study focused on 100 nursing have nonspecific back pain, patients have symptoms primarily in the back that suggest neither nerve root compromise nor a serious underlying condition.1 Mechanical low back pain is in this category. These patients also usually improve with conservative treatment. standing three days a week for eight hours a day. At age :( 30+-5) years, and height (153_165) cm. The interventions lasted five to 14 weeks.group A(use insoles) n=60 and group B(use insole placebo) n=40. Study outcomes had to include at least one of the following: self-reported incidence or physician diagnosis of back pain; pain intensity (Visual Analogue Rating scale (VAS)) we choose coz continues scale; duration of back pain(Acute back pain is arbitrarily defined as pain that has been present for six weeks or less. Sub acute back pain has a six- to 12-week duration and chronic back pain lasts longer than 12 weeks.); absenteeism; Syncope Functional Status Questionnaire: Responsiveness was assessed by comparing changes in SFSQ scores with changes in health status and clinical condition. Studies of insoles designed to treat limb length inequality were excluded. We measure before and after BP to see effective of insoles.

    Conclusion: Still, there is probably no need for further research regarding prevention of back pain with insoles, "because there is strong evidence that they don't help," Tali sahar, Ph.D said. "Further research is needed to assess if insoles are useful for treatment or secondary prevention (preventing backache in people who have already had back problems). Such trials should be of higher quality of methodology and reporting than those we have found."

     Sahar T, et al. Insoles for prevention and treatment of back pain (Review). Cochrane Database of Systematic Reviews 2007, Issue 4. Health Behavior News Service
    Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
    Washington, DC 20009
    United States

     Reliability, Validity and Responsiveness of the Syncope Functional Status Questionnaire, j Gen Intern Med. 2007 September; 22(9): 1280–1285. Published online 2007 July 3. doi: 10.1007/s11606-007-0266-5.
     The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale.DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. Department of Anesthesiology, Johns Hopkins Bayview Medical Center, Baltimore, MD 21224, USA

     sample size calculation, http://www.surveysystem.com/sample-size-formula.htm

     BMI Calculator , http://www.quesgen.com/Calculators/BMICalc/BMICalc.html.

     Assessment and Management of Acute Low Back Pain, ROBERT L. BRATTON, M.D. Mayo Clinic Jacksonville, Jacksonville, Florida

    many thanks
    Last edited by a moderator: Nov 19, 2009
  2. Admin2

    Admin2 Administrator Staff Member

    See these related threads: Low back
  3. If we are looking at prevention of back pain we need to understand a little more about it's causes. Back pain is complex and multifactoral. Insoles cannot prevent back pain caused by, for example, somebodies seated position or poor lifting technique. This will make such studies particularly hard because if we said that 30% of back pain is directly causes by lower limb issues and that only 30 % of THOSE will improve with orthoses, and that the Hawthorne / placebo rate for lbp runs around 40% it becomes well nigh impossible to get a big enough sample to get a decent p value.

    One of those times when large studies can mask significant subject specific data.

  4. foofoo

    foofoo Welcome New Poster

    thank you admin2

    robert......I determined the type of back pain(mechanical), and the goals to establish a connection either direct correlation or an inverse between lbp and insoles....Have been identified are not being insoles prevernt lbp.

    i think no. of sample is effect,just i wanna help to make good Literature .

    many thanks
  5. Craig Payne

    Craig Payne Moderator

    An important inclusion criteria would be back pain that gets worse with prolonged standing. That would, at least indicate that the problem could be related to postural alignment (ie possible foot biomehcanics)
  6. Also BMI index is at the moment being talked about a not a great guide to being overweight, due to muscle mass, bone density adding weight and making certain groups have high BMI when they are not overweight.

    The talk is going back to measurement critera as the best guide.
  7. I always applaud good literature.

    Is all mechanical back pain derived from gait problems?
  8. Craig Payne

    Craig Payne Moderator

    No. But the problem with doing the study proposed is including people who's back problem has a high probability it was due to something that could be altered by foot orthoses. I assume that back pain that gets worse on weightbearing is a good way to rule out those with back pain that is due to a lot of other causes.
  9. foofoo

    foofoo Welcome New Poster

    criag payen my bro....thank you soo much ,yeah it's important inclusion criteria i must put it.

    m weber....you right, i must put BMI in exclusion criteria,many thanks my dear.

    robertisaacs...thanks for your effort

    craig payne ....I reiterate once again thank you for your thoughts and gratitude of the bright.

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