Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Massage With Frankincense and Myrrh Oil in Treating Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04494165
Recruitment Status : Completed
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
ülkü özdemir, TC Erciyes University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: massage with frankincense and myyrh essential oil Other: massage with carrier oil Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3x2 (experiment, control and placebo group x pre-test post-test) split plot design
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.
Primary Purpose: Supportive Care
Official Title: The Effects of Massage With Frankincense and Myrrh Oil in Treating Chronic Low Back Pain: A Randomized Controlled Trial
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Myrrh

Arm Intervention/treatment
Experimental: 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.
Other: massage with frankincense and myyrh essential oil
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.

Placebo Comparator: 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.
Other: massage with carrier oil
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.

No Intervention: control group
30 patients in this group received standard physical therapy sessions, and no massage was applied.



Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: three weeks ]
    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.

  2. Aberdeen Low Back Pain Scale [ Time Frame: three weeks ]
    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%.

  3. Roland-Morris Disability Scale [ Time Frame: three weeks ]
    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%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over the age of 18,
  • who agreed to participate in the study,
  • who had no communication problems (hearing, vision, speech, perception problem)
  • who had been suffering from (chronic) low back pain for at least the past three months were included in the study.

Exclusion Criteria:

  • Patients with allergic skin reactions,
  • those who had undergone a surgical operation or fracture in the lumbar region in the last year,
  • those with a fever above 38.5 °C,
  • those undergoing a neurological rehabilitation,
  • patients with active infections such as tuberculosis and AIDS,
  • those undergoing cancer treatment,
  • those who had received massage therapy for the last three months were excluded from the study.

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): NCT04494165


Locations
Layout table for location information
Turkey
Ülkü Özdemir
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: ülkü özdemir erciyes üniversitesi
Layout table for additonal information
Responsible Party: ülkü özdemir, assistant professor doctor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT04494165    
Other Study ID Numbers: 2019/460
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no planing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ülkü özdemir, TC Erciyes University:
Massage
Low Back Pain
Aromatherapy
Chronic Pain
Activities of Daily Living
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations