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NCT Number: NCT07578181

Aromatherapy Massage in Chronic Low Back Pain

The aim was to investigate the effectiveness of adding aromatherapy massage with a mixture of lavender and orange oil to conventional physical therapy in individuals with chronic nonspecific low back pain on pain, central sensitization, functionality, sleep, quality of life, kinesiophobia, anxiety, and depression in this patient population.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Research and Training Hospital, Physical Therapy and Rehabilitation Clinic

Kırşehir, Merkez, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years
  • Chronic nonspecific low back pain ≥ 6 months
  • Volunteering to participate
  • Receiving treatment at physical therapy clinic

Exclusion criteria

  • History of orthopedic surgery, fracture, trauma
  • Inflammatory, rheumatologic, neurological, psychiatric disorders
  • Asthma
  • Current psychiatric medication use
  • Peripheral neuropathy or postherpetic neuralgia
  • Long-term corticosteroid use
  • Skin lesions/open wounds in treatment area
  • Allergy to lavender, orange, or almond oil
  • Positive allergic reaction to patch test

Treatment and study plan

Conventional Physiotherapy

Other

Hotpack (10 min) TENS (20 min) Ultrasound (5 min) Stretching & stabilization exercises (15 min) Frequency: 5 sessions/week for 4 weeks

Aromatherapy Massage + Conventional Physiotherapy

Other

Same conventional physiotherapy protocol Aromatherapy massage: Lavender + orange essential oil (%1.5 in sweet almond oil) 15 min/session 3 sessions/week for 4 weeks Massage techniques: effleurage, petrissage, friction, vibration

Primary outcomes

  1. McGill Pain Questionnaire

    Time frame: Baseline, 4 weeks

    The McGill Pain Questionnaire Short Form consists of 15 items evaluating sensory and affective dimensions of pain. Each item is scored on a 0-3 Likert scale, with total scores ranging from 0 to 45. Higher scores indicate greater pain severity.

  2. Pressure Pain Threshold (Algometer)

    Time frame: Baseline, 4 weeks

    Pressure pain threshold will be measured using an algometer to evaluate sensitivity in predefined anatomical points. The device quantifies the minimum pressure that induces pain.

  3. Central Sensitization Inventory

    Time frame: Baseline and 4 weeks

    The Central Sensitization Inventory is a 25-item questionnaire assessing symptoms related to central sensitization. Each item is scored on a 5-point Likert scale (0-4), with total scores ranging from 0 to 100. Higher scores indicate greater central sensitization symptoms.

Secondary outcomes

  1. Disability (Oswestry Disability Index)

    Time frame: Baseline and 4 weeks

    The Oswestry Disability Index consists of 10 items assessing functional disability related to low back pain. Each item is scored from 0 to 5, with total scores converted into percentage disability (0-100%).

  2. Quality of Life (SF-36)

    Time frame: Baseline and 4 weeks

    The SF-36 Health Survey evaluates quality of life across 8 domains including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional role, and mental health. Scores range from 0 to 100, with higher scores indicating better health status.

  3. Anxiety (Beck Anxiety Inventory)

    Time frame: Baseline and 4 weeks

    The Beck Anxiety Inventory is a 21-item scale measuring anxiety severity. Each item is scored from 0 to 3, with total scores ranging from 0 to 63.

  4. Depression (Beck Depression Inventory)

    Time frame: Baseline and 4 weeks

    The Beck Depression Inventory consists of 21 items assessing depressive symptoms. Total scores classify depression severity as minimal, mild, moderate, or severe.

  5. Kinesiophobia (Tampa Scale of Kinesiophobia)

    Time frame: Baseline and 4 weeks

    The Tampa Scale of Kinesiophobia includes 17 items rated on a 4-point Likert scale. Total scores range from 17 to 68, with higher scores indicating greater fear of movement.

  6. Sleep Quality (Pittsburgh Sleep Quality Index)

    Time frame: Baseline and 4 weeks

    The Pittsburgh Sleep Quality Index evaluates sleep quality across 7 components. Total scores range from 0 to 21, with scores above 5 indicating poor sleep quality.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Effect of Aromatherapy Massage in Individuals With Chronic Nonspecific Low Back Pain: A Double-Blind Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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