The Efficacy of Kinesio Taping in the Treatment of Nonspecific Acute Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The Purpose of the study was to examine the effect of KinesioTaping (KT) on disability, fear
      avoidance beliefs and pain intensity in patients with acute non-specific LBP. Materials and
      Methods: Seventy-eight patients were randomized to an experimental group that received
      traditional physical therapy plus KT and a control group that received traditional physical
      therapy alone. Interventions were administered twice a week for four weeks. Assessment tools
      used were; RMDQ for disability, FABQ for fear-avoidance beliefs and NPRS for pain intensity.
    

Detailed description: 
      This study followed a prospective experimental pretest-posttest control group randomized
      design with repeated measures. Two groups were included in this study, an experimental group
      and a control group. Both groups were tested with respect to three main outcomes which are
      disability, fear avoidance beliefs and pain intensity. Five points of measurements were used;
      at baseline, at the end of week 1, at the end of week 2, at the end of week 3 and at the end
      of week 4.

      A total of 88 patients with a primary complaint of low back pain were enrolled and consented
      to participate in the study. Potential study participants were assessed for study eligibility
      based on the pre-defined inclusion and exclusion criteria. Study flow chart. Subjects were
      pre-screened for known contraindications and precautions to thrust joint manipulation and
      exercises. No individuals were excluded from participation in this study based on race,
      creed, color, gender, age, national or ethnic origin, sexual orientation, disability, or
      health status.

      After obtaining the informed consent, participant's demographic information was collected
      including age, gender, ethnicity, contact information, emergency contact, employment status
      etc. History taking also included collecting information about patient's past medical
      history, family history, mechanism of injury, chief complaint, present history, number of
      days since onset, presence of previous episodes of low back pain, treatment for previous
      episodes, questions related to red flags, and review of systems and allergies. Patients were
      also checked for eligibility criteria. Pain characteristics were also documented including,
      pain intensity, location, duration, timing, character, aggravating and alleviating factors.
      History, review of systems and medical screening questionnaire were also used to identify red
      flags. Red flags are clinical features that may indicate a serious spinal pathology that
      warrant further investigation.

      Each participant was examined by the PI who conducted a thorough physical exam that included
      observation, palpation, and assessment of vertebral mobility, range of motion testing, muscle
      tests, neurological screening and special tests. Neurological examination included sensation
      for dermatomes, muscle testing for myotomes and deep tendon reflexes (Knee jerk and Ankle
      jerk). The allergy test for Kinesio taping was performed for all participants by the PI. An I
      strip of KT was applied on either side of lumbar spine at around 25% tension and left in
      place for 24 hours. The patient was checked during the second visit for any signs of adverse
      reactions such as rash or excessive hotness or itching in the tested area.

      The PI then opened a new file for the participant that included all the information obtained
      from history taking, physical examination and any other assessments. This process took
      between 30 minutes and 45 minutes. In the second visit, the tape was removed and the patient
      checked for any abnormal reactions. The participant was then randomized to either the
      experimental group or the control group using random number generator.

      The PI provided the research assistant with participant's basic information including the
      case number but the research assistant was not aware of the participant group allocation. The
      research assistant then performed all baseline outcome assessments required for the study
      which included disability as measured with the Ronald Morris Disability Questionnaire, fear
      avoidance beliefs as measured with Fear Avoidance Beliefs Questionnaire and pain as measured
      with the Numerical Pain Rating Scale. The research assistant conducted all study related
      measurements at baseline (W0), at the end of the first week (W1), at the end of the second
      week (W2), at the end of the third week (W3) and at the end of the fourth week (W4) and kept
      all data in a separate locked file cabinet. The second visit took approximately between 45
      and 60 minutes to be completed including providing first treatment session. Assessments of
      study variables took 15 to 20 minutes.

      A priori analysis was conducted with an alpha level (α) of 0.05, an effect size of 0.25 and a
      power of 80 % using G*Power (Version 3.0.10). The results indicated that a total 78 subjects
      would be needed of two groups. However, considering a potential 10-15 % dropout or loss to
      follow-up rate, around 42 to 45 participants were considered for each group.

      Blinding the physical therapist (the principal investigator) who provided interventions to
      both groups in the study to the type of intervention was not feasible. Blinding the principal
      investigator to the assessment process was possible by using another physical therapist who
      conducted all measurements. Blinding the assessor to subject's group assignment was done to
      ensure unbiased ascertainment of outcomes. Randomization also served to reduce the risk of
      selection bias by the principal investigator. An online random number generator available at
      http://www.graphpad.com/quickcalcs/randomize1/ was used to randomly assign participants to
      two equal groups. The study was conducted at Quick Docs Medical Center located in Brooklyn,
      NY. This facility is the primary place of employment of the principal investigator and the
      research assistant. The facility has private treatment rooms where each subject was
      interviewed and assessment and intervention sessions were conducted. All research activities
      were approved by the IRB of NOVA Southeastern University. IRB approval was granted on the
      29th of June of 2015. All patients provided informed consent prior to participation.

      The outcome variables which were included in the study are; disability, fear-avoidance
      beliefs and pain intensity. The primary outcome was disability and the secondary outcomes
      were fear avoidance beliefs and pain intensity. Disability was evaluated with the
      Ronald-Morris Disability Questionnaire (RMDQ). RMDQ is a patient reported outcome measure
      that is composed of 24 yes/no questions to assess functional status and disability in
      patients with low back pain. RMDQ scores can range from 0, the highest functional status
      indicating no disability, to 24, the lowest functional status indicating maximum disability.
      Patients were asked to mark the sentences that describe them at the time of evaluation.

      Fear avoidance beliefs questionnaire (FABQ) is an assessment tool that is developed based on
      the fear avoidance model of exaggerated pain perception. This model is a theoretical approach
      of analyzing the behavior of patients with acute conditions as some of these patients recover
      successfully while others develop chronic pain. FABQ measures patient's fear of pain in terms
      of patients' behavior as a result of pain in relation to general physical activities and work
      related functions because of their fear. It consists of two subscales, a work subscale and a
      physical activity subscale; each item is scored from 0 to 6. Greater fear and consequent
      avoidance beliefs are associated with higher scores.

      Assessment of pain was done using the numerical rating of pain scale (NPRS), which is an
      11-point scale from 0 to 10, 0 indicating "no pain" and 10 indicating "the worst pain". Pain
      assessments were conducted at baseline and at the end of each week, for four weeks. A verbal
      response was required from each participant. Three measurements were taken, the current pain
      level, the worst pain level over the last 24 hours and the lowest pain level over the last 24
      hours. The average of the three readings was used as the average pain level for each
      participant.

      Descriptive statistics was conducted to describe all basic characteristics of participants of
      both groups. Variables such as age, gender, presence of previous episodes, and duration of
      the current episode were described. Graphical representation of the above-mentioned variables
      as well as the main outcome measures were obtained from statistical software. Tables and
      figures were used to provide an understanding of all relevant study data. Mixed model
      analysis of variance (ANOVA) was used to reveal main effects and interaction effects. The
      group type was the between-subjects' variable and the time was the within subjects' variable.
      Bonferroni post-tests were used to compare between groups at each individual point of time.
      SPSS Version 23.0 (SPSS, Inc., IBM Corporation, Somers, New York) and GraphPad Prism (Version
      6.01 for Windows; GraphPad Software, San Diego, CA, USA) were used for statistical analysis.

      All patients' data and records pertaining to this research study and any relevant information
      were stored in a locked file cabinet at the facility in which the study was conducted. A case
      number was used to indicate patient's identity on these records. This information was only
      accessible to the principal investigator, the independent physical therapist, and other
      research study staff involved in conducting this research study. All assessment data were
      kept in a separate locked file cabinet which was accessible only to the independent physical
      therapist. To ensure confidentiality, no confidential information such as patient's name,
      address, phone number, or any other information that might possibly be used to link the data
      to the patient was transmitted or shared. These measures were used to ensure patients'
      confidentiality.
    

Intervention name(s): Kinesio Taping; Traditional Physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Taping for 3 days every week and two sessions of PT twice a week. The PI also instructed the patient to inform him if the tape gets off or become loose. KT was removed after 72 hours, and then reapplied after a few days rest to allow the skin to recover and to avoid skin irritation. The patient was instructed to refrain from getting the tape wet for 30 to 45 minutes after application to allow for better adherence. Patients were also instructed to be careful during dressing and undressing so the tape does not get caught with their clothes if the edges of the tape get slightly loose. No physical therapy treatment or taping was provided during the rest period except for the prescribed home exercise program. Patients in both groups received the same traditional physical therapy treatment two times a week.; Traditional physical therapy was in the form of patient education, manual therapy and therapeutic exercises. Patient education focused on the natural history of the condition and its favorable prognosis, positive thinking, and encouragement of activity participation. Patient education was delivered through one-on-one discussion by the principal investigator.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study followed a prospective experimental pretest-posttest control group randomized design with repeated measures. Two groups were included in this study, an experimental group and a control group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment