NCT05769192

Brief Summary

The aim of this study is to examine the effects of classical massage on pain, spinal mobility, functional and psychological state, and life quality in individuals with chronic low back pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2023

Status
unknown

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

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity will be evaluated with a 10 cm Visual Analog Scale (VAS). The VAS is scored on a 10 cm horizontal line, with 0 meaning "no pain" and 10 "worst pain imaginable". Patients will be asked to mark their lower back pain on the horizontal line.

    change from baseline at 3 weeks

Secondary Outcomes (4)

  • Spinal mobility

    change from baseline at 3 weeks

  • Functional status

    change from baseline at 3 weeks

  • Psychological state

    change from baseline at 3 weeks

  • Life quality

    change from baseline at 3 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will be applied classical physiotherapy and classical massage

Other: Classical physiotherapy and classical massage

Group 2

PLACEBO COMPARATOR

Group 2 will be applied classical physiotherapy and placebo massage

Other: Classical physiotherapy and placebo massage

Interventions

Within the scope of classical physiotherapy, hot pack will be applied for 20 minutes to the muscles in the lumbar region in the prone position. Stretching and strengthening exercises for the abdominal, lumbar and hip muscles will be given. Classical massage, known as Swedish massage, will be applied on the lumbar region in prone position. All applications will be done 5 days a week for 3 weeks.

Group 1

Within the scope of classical physiotherapy, hot pack will be applied for 20 minutes to the muscles in the lumbar region in the prone position. Stretching and strengthening exercises for the abdominal, lumbar and hip muscles will be given. In addition, placebo massage, applied without using any technique, will be applied to the lumbar region in the prone position. All applications will be done 5 days a week for 3 weeks.

Group 2

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-65,
  • Having non-specific low back pain lasting at least 3 months,
  • Individuals willing to participate in the study

You may not qualify if:

  • Having different pain syndromes (eg fibromyalgia)
  • Having a history of spinal surgery or invasive examination in the last 6 months,
  • Having a neurological or psychiatric disease
  • Any ongoing related pathology (eg spondylolisthesis, fractures, tumor, osteoporosis or infection),
  • Those with pregnancy status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

March 30, 2023

Primary Completion

April 30, 2023

Study Completion

March 30, 2024

Last Updated

March 15, 2023

Record last verified: 2023-03