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

NCT04494165 | Completed

• 1 other identifier: 2019/460
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Massage; Low Back Pain; Aromatherapy; Chronic Pain; Activities of Daily Living

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale

  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.

  three weeks

• Aberdeen Low Back Pain Scale

  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%.

  three weeks

• Roland-Morris Disability Scale

  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%

  three weeks

Study Arms (3)

Aromatherapy Group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

control group

NO INTERVENTION

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

Interventions

massage with frankincense and myyrh essential oil OTHER

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.

Aromatherapy Group

massage with carrier oil OTHER

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.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Ülkü Özdemir

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

• Alkanat HO, Ozdemir U, Kulakli F. The effects of massage with frankincense and myrrh oil in chronic low back pain: A three-arm randomised controlled trial. Explore (NY). 2023 Sep-Oct;19(5):761-767. doi: 10.1016/j.explore.2023.04.004. Epub 2023 Apr 14.

  PMID: 37121835 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Massage; Frankincense; Carrier State

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Epidemiologic Methods; Public Health; Environment and Public Health

Study Officials

• ülkü özdemir

  erciyes üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Model Details: 3x2 (experiment, control and placebo group x pre-test post-test) split plot design

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: July 1, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)