NCT07578181

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
3mo left

Started May 2025

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
May 2025Aug 2026

Study Start

First participant enrolled

May 20, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Low Back PainAromatherapyMassage

Outcome Measures

Primary Outcomes (3)

  • McGill Pain Questionnaire

    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.

    Baseline, 4 weeks

  • Pressure Pain Threshold (Algometer)

    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.

    Baseline, 4 weeks

  • Central Sensitization Inventory

    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.

    Baseline and 4 weeks

Secondary Outcomes (6)

  • Disability (Oswestry Disability Index)

    Baseline and 4 weeks

  • Quality of Life (SF-36)

    Baseline and 4 weeks

  • Anxiety (Beck Anxiety Inventory)

    Baseline and 4 weeks

  • Depression (Beck Depression Inventory)

    Baseline and 4 weeks

  • Kinesiophobia (Tampa Scale of Kinesiophobia)

    Baseline and 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

Aromatherapy Massage + Conventional Physiotherapy

EXPERIMENTAL

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

Other: Aromatherapy Massage + Conventional Physiotherapy

Interventions

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

Conventional Physiotherapy

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

Aromatherapy Massage + Conventional Physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Research and Training Hospital, Physical Therapy and Rehabilitation Clinic

Kırşehir, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

May 20, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations