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Investigating the effect of massage-aromatherapy with body balms on patients suffering from chronic pain caused by lumbar disc herniation

The Immediate and Long-Term Effects of Massage-Aromatherapy Using Body Balms on Pain Intensity and Disability in Patients Affected by Disc Bulging (L4/5)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240923063136N1
Enrollment
48
Registered
2025-04-08
Start date
2024-10-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pains of disc bulging (L4/5). Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement

Interventions

Intervention 1: Intervention group 1: Receives massage using type 1 balm. 20 minutes of massage with application in a very quiet environment by a person proficient in massage techniques will be given

Sponsors

Razi University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: women in the age range between 35 and 60 years who have a pain intensity higher than 3 on the VAS scale Three months have passed since their pain Have symptoms of pain spreading to the back and hips

Exclusion criteria

Exclusion criteria: Patients with diabetes, HIV, diseases and problems of the immune system and with a history of disc surgery are not included in the study. Pregnant, lactating women or those who intend to become pregnant are excluded from the study. People who use corticosteroids or topical pain relievers locally or systemically will be excluded from the study. Patients who have had a history of allergic reaction to vegetable oils are not included in the study.

Design outcomes

Primary

MeasureTime frame
Pain: To measure the intensity of pain, VAS visual pain scale will be applied, which is a sensitive scale and has validity and reliability of 0.94 to 0.97. This scale is a 10 cm long graduated line on which the patient must self-assess his perception of the pain intensity in the back area on this graduated ruler from 0 (no pain) to 10 (the worst pain).In addition to VAS, pain assessment will also be evaluated with the McGill questionnaire. This questionnaire has 78 statements in 20 sets to describe the quality of pain, and its purpose is to measure people's understanding of different dimensions of pain, including four dimensions: sensory pain, affective pain, evaluative pain, and various pains (Miscellaneous pain). Collection 1 to 10 is related to sensory perception, collection 11 to 15 is related to emotional perception, collection 16 is related to evaluation perception, and collection 17 to 20 is related to various pains. In each set, a minimum of two and a maximum of six expressions are specified to describe the pain, and the participant receives the score for that set by choosing only one expression that best describes her pain. These expressions are arranged in order of intensity from weak to severe in each set, and the score of each expression is from 1 to 6, corresponding to its position in each set. If the respondent does not find any of the statements to describe her pain, that set is given a score of 0. The score related to each dimension is obtained from the sum of each set related to that dimension, which is a maximum of 42 points for the sensory perception dimension, a maximum of 14 points for the emotional perception dimension, a maximum of 5 points for the evaluation perception dimension, and a maximum of 17 points for the various pains dimension. It is different. The overall score of the questionnaire will be obtained from the sum of the scores of each set (maximum 78 points). Necessary explanations for completing the McGill questionnaire is in Farsi

Secondary

MeasureTime frame
Physical performance (UGT test, 40-meter walking test): To evaluate the functional capacity of the subjects before/after the study interventions, the Time Up and Go tests is applied. The length of time takes the patient to stand up unaided from a chair with handles (without using the handles) and walk a distance of three-meter and then come back and sit on the chair will be recorded. Also, the walking test in a distance of 40 meters will be used to measure the functional capacity of the patients, in which the time taken by the patient to cover a distance of 40 meters is recorded by a stopwatch. Timepoint: After receiving 12 treatment sessions - after two months of the completion of the treatment period. Method of measurement: UGT test, 40-meter walking test.;Level of anxiety: It will be determined based on Spielberger's state-trait anxiety questionnaire. This questionnaire is widely used to measure anxiety in clinical studies and has a correlation coefficient of 0.91-0.85. This questionnaire contains 20 items and is prepared based on a four-point Likert scale, which ranges from very little to very much. Since each item is given 1-4 points, the total score of anxiety varied between 20 and 80: mild anxiety (20-40), moderate anxiety (41-60) and severe anxiety (61-80). Timepoint: After receiving 12 treatment sessions - after two months of the completion of the treatment period. Method of measurement: Spielberger's state-trait anxiety questionnaire.;Lumbar spine range of motion (flexion): Lumbar flexion range of motion was measured with the modified Schuber test. First, indentation points below the waist will be marked as a reference point, and then 5 cm below and 10 cm above it will be determined with a marker. The patient will be asked to bend forward and then back as far as possible with a straight knee, the distance between these two points will be measured with a tape measure and will be considered as the range of motion of flexion and extension of the back. Timepoi

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzaneh Gandomi

Razi University

gandomi777@gmail.com+98 38 3434 3515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026