<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494165</url>
  </required_header>
  <id_info>
    <org_study_id>2019/460</org_study_id>
    <nct_id>NCT04494165</nct_id>
  </id_info>
  <brief_title>Massage With Frankincense and Myrrh Oil in Treating Chronic Low Back Pain</brief_title>
  <official_title>The Effects of Massage With Frankincense and Myrrh Oil in Treating Chronic Low Back Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TC Erciyes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled study was conducted to determine the effect of massage with&#xD;
      frankincense and myrrh oil in treating chronic low back pain.&#xD;
&#xD;
      A total of 91 individuals over the age of 18 who agreed to participate in the study, who had&#xD;
      no verbal communication problems, and who had complaints of low back pain for at least the&#xD;
      past three months were included in the study. In this research, 3x2 (experiment, control and&#xD;
      plasebo group x pre-test post-test) split plot design was used The data were collected using&#xD;
      the data sheet, Visual Analogue Scale (VAS), Aberdeen Low Back Pain Scale (ALBPS) and&#xD;
      Roland-Morris Disability Scale (RMDS). Standard treatment was applied to all three groups for&#xD;
      three weeks, every weekday. In addition to the standard treatment, 2 sessions of waist&#xD;
      massage per week were applied to the aromatherapy Group with frankincense and myyrh essential&#xD;
      oil and to the Placebo Group with jojoba fixed oil in accordance with the aromatherapy&#xD;
      protocol. Massage was not applied to the control group.&#xD;
&#xD;
      In the results of working, the decrease in RMDS (p &lt;0.001), ALBPS (p &lt;0.001) and VAS (p&#xD;
      &lt;0.001) scores of the aromatherapy group was found to be statistically higher than the other&#xD;
      two groups.&#xD;
&#xD;
      As a result, aromatherapy massage with Fankincense and Myyrh essential oil can be added to&#xD;
      traditional treatments as an easy-to-apply complementary health application with no&#xD;
      significant side effects to relieve pain and reduce disability in an individual's daily life&#xD;
      in chronic low back pain patient care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research was conducted as a randomized, double-blinded, placebo-controlled study to&#xD;
      examine the effect of massage with frankincense and myrrh essential oils on pain and&#xD;
      disability in individuals with chronic low back pain. In this research, 3x2 (experiment,&#xD;
      control and placebo group x pre-test post-test) split plot design was used. The measurements&#xD;
      and evaluations of the patients were conducted by an independent surveyor (assessor-blind) to&#xD;
      ensure that the study was double-blind. Massage application, the main intervention of the&#xD;
      study, was carried out by another nurse who was trained on this subject.&#xD;
&#xD;
      Individuals presenting with chronic low back pain, who were admitted to the physical medicine&#xD;
      and rehabilitation outpatient clinic of a training and research hospital and who were&#xD;
      prescribed a physical therapy session constituted the target population of the study.&#xD;
&#xD;
      For the sample size, 30-31-30 patients were included in the experimental, placebo and control&#xD;
      groups, between June and October 2019, respectively, and power analysis was performed with&#xD;
      the obtained data. As a result of power analysis, the effect size for Roland-Morris&#xD;
      Disability Scale (RMDS) was 0.44 and statistical power was 100%; the effect size for Aberdeen&#xD;
      Low Back Pain Scale (ALBPS) was 0.53 and the statistical power was 100%; and the effect size&#xD;
      for Visual Analogue Scale (VAS) was 0.29 and statistical power was 100%, and the research was&#xD;
      completed.&#xD;
&#xD;
      Individuals who meet the inclusion criteria were included in the randomization pool and then&#xD;
      assigned to one of the following groups:&#xD;
&#xD;
        1. Aromatherapy Group which had classical massage with essential oil,&#xD;
&#xD;
        2. Placebo Group which had classical massage with a fixed oil,&#xD;
&#xD;
        3. Control Group. Pre-application was made to 5 individuals to check the functionality of&#xD;
           the forms and application. In the pre-application, it was decided that only effleurage&#xD;
           and friction should be performed, since the individuals were disturbed by petrissage&#xD;
           during massage. After pre-application, the study was finalized. Individuals who&#xD;
           participated in pre-application were not included in the study.&#xD;
&#xD;
      Informed consent of the individuals randomly assigned to the groups was obtained. There was&#xD;
      no intervention in the standard treatment applied in the clinic. At the beginning of the&#xD;
      study, VAS, ALBPS, RMDS were applied to all three groups prior to the intervention by&#xD;
      face-to-face interview method. Then, all three groups received standard treatment for three&#xD;
      weeks, every weekday. In addition to the standard treatment, aromatherapy group was applied 2&#xD;
      sessions of 15 min lumbar massage per week (2nd and 5th day) with frankincense and myrrh&#xD;
      essential oils, and the placebo group was applied lumbar massage with jojoba fixed oil in the&#xD;
      same frequency. Massage was not applied to the control group. After three weeks, VAS, ALBPS,&#xD;
      RMDS were applied to all 3 groups after the intervention Massage Application: Although there&#xD;
      are many massage techniques, the most widely used technique is Swedish massage technique&#xD;
      applied with light pressure. Swedish massage is a superficial massage and has a stimulating&#xD;
      effect on soft tissues and blood circulation. The main maneuvers of classical massage are&#xD;
      effleurage, petrissage, friction, tapotement and vibration. In this study, effleurage and&#xD;
      friction were applied from these maneuvers.&#xD;
&#xD;
      Effleurage is a stroking movement applied on the skin with one hand or both hands. In the&#xD;
      stroking technique, palms, fingers, thumb and back of hand is applied with one or two hands.&#xD;
      The aim is to accelerate blood flow in superficial veins and excretion of metabolites from&#xD;
      the body. Friction is the pressing, scrubbing and sliding movements with small circular&#xD;
      movements using fingertips, thumbs, four fingers and palms. The purpose of friction is to&#xD;
      remove adhesions in skin and subcutaneous tissue, to relax stiffness and thickening, to&#xD;
      reduce fluid in tissues around joints and to remove metabolites.&#xD;
&#xD;
      Essential oils from plants are used topically for massaging, often by adding them into&#xD;
      carrier oil The use of essential oils in massage is called aromatherapy massage. In this&#xD;
      study, frankincense and myrrh essential oils were used as essential oil and jojoba oil was&#xD;
      used as carrier oil.&#xD;
&#xD;
      Intervention: The standard physical therapy session of the clinic lasts for three weeks&#xD;
      (3x5=15 sessions in total, 30 minutes on average per session) on a weekday basis. During the&#xD;
      session, hot pack, ultrasound therapy and TENS (trans electrical nerve stimulation) were&#xD;
      applied. The lumbar massage performed as a research intervention was performed immediately&#xD;
      after the physical therapy session to increase the effectiveness of the intervention.&#xD;
&#xD;
      Intervention applied to the aromatherapy group: In addition to the standard physical therapy&#xD;
      session, 30 patients in this group received a total of six sessions of lumbar massage for&#xD;
      three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th&#xD;
      days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture&#xD;
      prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was&#xD;
      used as an oil mixture.&#xD;
&#xD;
      Intervention applied to the placebo group: In addition to the standard physical therapy&#xD;
      session, 31 patients in this group received a total of six sessions of lumbar massage for&#xD;
      three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each&#xD;
      lasting 15 minutes.&#xD;
&#xD;
      Intervention applied to the control group: 30 patients in this group received standard&#xD;
      physical therapy sessions, and no massage was applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">November 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>3x2 (experiment, control and placebo group x pre-test post-test) split plot design</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The measurements and evaluations of the patients were conducted by an independent surveyor (assessor-blind) to ensure that the study was double-blind. Massage application, the main intervention of the study, was carried out by another nurse who was trained on this subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>three weeks</time_frame>
    <description>It is stated that VAS is more sensitive and reliable than other one-dimensional scales in the measurement of pain intensity(*). In their study, Cline, Herman, Show et al. (1992) have reported that vertical use of VAS is better understood by patients. (*). It was used in our study to assess the severity of low back pain. It is a-10 cm ruler with endpoints of &quot;no pain&quot; at one end and &quot;unbearable pain&quot; at the other end. The scale was explained to the patient and they were asked to mark any place between these two points that matched the severity of their pain. The distance between the beginning of &quot;no pain&quot; and the point marked by the patient was measured and recorded in centimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aberdeen Low Back Pain Scale</measure>
    <time_frame>three weeks</time_frame>
    <description>It is a scale that patients can fill out by themselves to decide on the health status of patients with low back pain. It is a 19-item scale consisting of questions about number of days with pain, use of painkillers, factors that increase and decrease pain, pain areas, sensory change, loss of strength/weakness, lumbar flexion, difficulty falling asleep due to pain, sitting, getting up, walking, work/daily activities, sex life, leisure activities, self-care, and days spent in bed. The total score of the scale adapted to Turkish by İlhanlı et al. ranges between 0 and 100, and the high score indicates more severe low back pain. Its Cronbach's Alpha value was indicated as 0.88 (*). In our study, the power of the scale was 100%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland-Morris Disability Scale</measure>
    <time_frame>three weeks</time_frame>
    <description>The patient is asked to mark the appropriate ones among the 24 cases specified in this form. RMDS consists of 24 expressions based on the patient's perception of low back pain and associated disability. These items are indicated as physical activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and frequency of pain (1) (*).This test is based on measuring how low back pain affects the patient's activities of daily living. Yes responses are calculated as &quot;1&quot;, no responses as &quot;0&quot; points, and a total score between 0 and 24 is obtained. Higher score means more disability. The Turkish validity study of the scale was conducted by Küçükdeveci et al. Cronbach's alpha value of the scale was indicated as 0.85-0.89 (*). In our study, the power of the scale was 100%</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Aromatherapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard physical therapy session, 30 patients in this group received a total of six sessions of lumbar massage for three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was used as an oil mixture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In addition to the standard physical therapy session, 31 patients in this group received a total of six sessions of lumbar massage for three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>30 patients in this group received standard physical therapy sessions, and no massage was applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>massage with frankincense and myyrh essential oil</intervention_name>
    <description>In addition to the standard physical therapy session, 30 patients in aromatherapy group received a total of six sessions of lumbar massage for three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was used as an oil mixture.</description>
    <arm_group_label>Aromatherapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>massage with carrier oil</intervention_name>
    <description>In addition to the standard physical therapy session, 31 patients in placebo group received a total of six sessions of lumbar massage for three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes.</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18,&#xD;
&#xD;
          -  who agreed to participate in the study,&#xD;
&#xD;
          -  who had no communication problems (hearing, vision, speech, perception problem)&#xD;
&#xD;
          -  who had been suffering from (chronic) low back pain for at least the past three months&#xD;
             were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergic skin reactions,&#xD;
&#xD;
          -  those who had undergone a surgical operation or fracture in the lumbar region in the&#xD;
             last year,&#xD;
&#xD;
          -  those with a fever above 38.5 °C,&#xD;
&#xD;
          -  those undergoing a neurological rehabilitation,&#xD;
&#xD;
          -  patients with active infections such as tuberculosis and AIDS,&#xD;
&#xD;
          -  those undergoing cancer treatment,&#xD;
&#xD;
          -  those who had received massage therapy for the last three months were excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ülkü özdemir</last_name>
    <role>Principal Investigator</role>
    <affiliation>erciyes üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ülkü Özdemir</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TC Erciyes University</investigator_affiliation>
    <investigator_full_name>ülkü özdemir</investigator_full_name>
    <investigator_title>assistant professor doctor</investigator_title>
  </responsible_party>
  <keyword>Massage</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Aromatherapy</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Activities of Daily Living</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no planing</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494165
org study id: 2019/460
nct id: NCT04494165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled study was conducted to determine the effect of massage with
      frankincense and myrrh oil in treating chronic low back pain.

      A total of 91 individuals over the age of 18 who agreed to participate in the study, who had
      no verbal communication problems, and who had complaints of low back pain for at least the
      past three months were included in the study. In this research, 3x2 (experiment, control and
      plasebo group x pre-test post-test) split plot design was used The data were collected using
      the data sheet, Visual Analogue Scale (VAS), Aberdeen Low Back Pain Scale (ALBPS) and
      Roland-Morris Disability Scale (RMDS). Standard treatment was applied to all three groups for
      three weeks, every weekday. In addition to the standard treatment, 2 sessions of waist
      massage per week were applied to the aromatherapy Group with frankincense and myyrh essential
      oil and to the Placebo Group with jojoba fixed oil in accordance with the aromatherapy
      protocol. Massage was not applied to the control group.

      In the results of working, the decrease in RMDS (p <0.001), ALBPS (p <0.001) and VAS (p
      <0.001) scores of the aromatherapy group was found to be statistically higher than the other
      two groups.

      As a result, aromatherapy massage with Fankincense and Myyrh essential oil can be added to
      traditional treatments as an easy-to-apply complementary health application with no
      significant side effects to relieve pain and reduce disability in an individual's daily life
      in chronic low back pain patient care.
The research was conducted as a randomized, double-blinded, placebo-controlled study to
      examine the effect of massage with frankincense and myrrh essential oils on pain and
      disability in individuals with chronic low back pain. In this research, 3x2 (experiment,
      control and placebo group x pre-test post-test) split plot design was used. The measurements
      and evaluations of the patients were conducted by an independent surveyor (assessor-blind) to
      ensure that the study was double-blind. Massage application, the main intervention of the
      study, was carried out by another nurse who was trained on this subject.

      Individuals presenting with chronic low back pain, who were admitted to the physical medicine
      and rehabilitation outpatient clinic of a training and research hospital and who were
      prescribed a physical therapy session constituted the target population of the study.

      For the sample size, 30-31-30 patients were included in the experimental, placebo and control
      groups, between June and October 2019, respectively, and power analysis was performed with
      the obtained data. As a result of power analysis, the effect size for Roland-Morris
      Disability Scale (RMDS) was 0.44 and statistical power was 100%; the effect size for Aberdeen
      Low Back Pain Scale (ALBPS) was 0.53 and the statistical power was 100%; and the effect size
      for Visual Analogue Scale (VAS) was 0.29 and statistical power was 100%, and the research was
      completed.

      Individuals who meet the inclusion criteria were included in the randomization pool and then
      assigned to one of the following groups:

        1. Aromatherapy Group which had classical massage with essential oil,

        2. Placebo Group which had classical massage with a fixed oil,

        3. Control Group. Pre-application was made to 5 individuals to check the functionality of
           the forms and application. In the pre-application, it was decided that only effleurage
           and friction should be performed, since the individuals were disturbed by petrissage
           during massage. After pre-application, the study was finalized. Individuals who
           participated in pre-application were not included in the study.

      Informed consent of the individuals randomly assigned to the groups was obtained. There was
      no intervention in the standard treatment applied in the clinic. At the beginning of the
      study, VAS, ALBPS, RMDS were applied to all three groups prior to the intervention by
      face-to-face interview method. Then, all three groups received standard treatment for three
      weeks, every weekday. In addition to the standard treatment, aromatherapy group was applied 2
      sessions of 15 min lumbar massage per week (2nd and 5th day) with frankincense and myrrh
      essential oils, and the placebo group was applied lumbar massage with jojoba fixed oil in the
      same frequency. Massage was not applied to the control group. After three weeks, VAS, ALBPS,
      RMDS were applied to all 3 groups after the intervention Massage Application: Although there
      are many massage techniques, the most widely used technique is Swedish massage technique
      applied with light pressure. Swedish massage is a superficial massage and has a stimulating
      effect on soft tissues and blood circulation. The main maneuvers of classical massage are
      effleurage, petrissage, friction, tapotement and vibration. In this study, effleurage and
      friction were applied from these maneuvers.

      Effleurage is a stroking movement applied on the skin with one hand or both hands. In the
      stroking technique, palms, fingers, thumb and back of hand is applied with one or two hands.
      The aim is to accelerate blood flow in superficial veins and excretion of metabolites from
      the body. Friction is the pressing, scrubbing and sliding movements with small circular
      movements using fingertips, thumbs, four fingers and palms. The purpose of friction is to
      remove adhesions in skin and subcutaneous tissue, to relax stiffness and thickening, to
      reduce fluid in tissues around joints and to remove metabolites.

      Essential oils from plants are used topically for massaging, often by adding them into
      carrier oil The use of essential oils in massage is called aromatherapy massage. In this
      study, frankincense and myrrh essential oils were used as essential oil and jojoba oil was
      used as carrier oil.

      Intervention: The standard physical therapy session of the clinic lasts for three weeks
      (3x5=15 sessions in total, 30 minutes on average per session) on a weekday basis. During the
      session, hot pack, ultrasound therapy and TENS (trans electrical nerve stimulation) were
      applied. The lumbar massage performed as a research intervention was performed immediately
      after the physical therapy session to increase the effectiveness of the intervention.

      Intervention applied to the aromatherapy group: In addition to the standard physical therapy
      session, 30 patients in this group received a total of six sessions of lumbar massage for
      three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th
      days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture
      prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was
      used as an oil mixture.

      Intervention applied to the placebo group: In addition to the standard physical therapy
      session, 31 patients in this group received a total of six sessions of lumbar massage for
      three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each
      lasting 15 minutes.

      Intervention applied to the control group: 30 patients in this group received standard
      physical therapy sessions, and no massage was applied.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3x2 (experiment, control and placebo group x pre-test post-test) split plot design
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: The measurements and evaluations of the patients were conducted by an independent surveyor (assessor-blind) to ensure that the study was double-blind. Massage application, the main intervention of the study, was carried out by another nurse who was trained on this subject.
measure: Visual Analogue Scale
time frame: three weeks
description: It is stated that VAS is more sensitive and reliable than other one-dimensional scales in the measurement of pain intensity(*). In their study, Cline, Herman, Show et al. (1992) have reported that vertical use of VAS is better understood by patients. (*). It was used in our study to assess the severity of low back pain. It is a-10 cm ruler with endpoints of "no pain" at one end and "unbearable pain" at the other end. The scale was explained to the patient and they were asked to mark any place between these two points that matched the severity of their pain. The distance between the beginning of "no pain" and the point marked by the patient was measured and recorded in centimeters.
measure: Aberdeen Low Back Pain Scale
time frame: three weeks
description: It is a scale that patients can fill out by themselves to decide on the health status of patients with low back pain. It is a 19-item scale consisting of questions about number of days with pain, use of painkillers, factors that increase and decrease pain, pain areas, sensory change, loss of strength/weakness, lumbar flexion, difficulty falling asleep due to pain, sitting, getting up, walking, work/daily activities, sex life, leisure activities, self-care, and days spent in bed. The total score of the scale adapted to Turkish by İlhanlı et al. ranges between 0 and 100, and the high score indicates more severe low back pain. Its Cronbach's Alpha value was indicated as 0.88 (*). In our study, the power of the scale was 100%.
measure: Roland-Morris Disability Scale
time frame: three weeks
description: The patient is asked to mark the appropriate ones among the 24 cases specified in this form. RMDS consists of 24 expressions based on the patient's perception of low back pain and associated disability. These items are indicated as physical activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and frequency of pain (1) (*).This test is based on measuring how low back pain affects the patient's activities of daily living. Yes responses are calculated as "1", no responses as "0" points, and a total score between 0 and 24 is obtained. Higher score means more disability. The Turkish validity study of the scale was conducted by Küçükdeveci et al. Cronbach's alpha value of the scale was indicated as 0.85-0.89 (*). In our study, the power of the scale was 100%
arm group label: Aromatherapy Group
arm group type: Experimental
description: In addition to the standard physical therapy session, 30 patients in this group received a total of six sessions of lumbar massage for three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was used as an oil mixture.
arm group label: placebo group
arm group type: Placebo Comparator
description: In addition to the standard physical therapy session, 31 patients in this group received a total of six sessions of lumbar massage for three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes.
arm group label: control group
arm group type: No Intervention
description: 30 patients in this group received standard physical therapy sessions, and no massage was applied.
intervention type: Other
intervention name: massage with frankincense and myyrh essential oil
description: In addition to the standard physical therapy session, 30 patients in aromatherapy group received a total of six sessions of lumbar massage for three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was used as an oil mixture.
arm group label: Aromatherapy Group
intervention type: Other
intervention name: massage with carrier oil
description: In addition to the standard physical therapy session, 31 patients in placebo group received a total of six sessions of lumbar massage for three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes.
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ülkü özdemir
role: Principal Investigator
affiliation: erciyes üniversitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: TC Erciyes University
investigator full name: ülkü özdemir
investigator title: assistant professor doctor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
ipd description: no planing