NCT07518732

Brief Summary

Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 22, 2026

Last Update Submit

April 2, 2026

Conditions

MECHANICAL BACK PAINSleep Quality

Keywords

Mechanical Back PainMassageManipulationFlexibilitySleep QualityPain

Outcome Measures

Primary Outcomes (4)

  • Pain Assessment

    VAS will be used to measure pain intensity. A 10 cm long line is used, where 0 represented no pain and 10 represented very severe pain. The distance from the marked point to 0 is recorded as a VAS score.

    From enrollment and after 4 weeks

  • Sit and Reach test

    The participant is asked to sit with their feet extended under the test bench. Without bending their knees, they are asked to lean their body forward and reach as far as possible on their fingertips, holding at that point for 2 seconds.

    From enrollment and after 4 weeks

  • Trunk extension

    Trunk extension: In the trunk extension flexibility test, the participant stands facing the wall, with their hips and torso in contact with the wall. The distance between the sternal notch and the wall is measured using a tape measure.

    From enrollment and after 4 weeks

  • Lateral flexion

    Right and left trunk lateral flexion flexibility test: The participant is positioned standing; feet shoulder-width apart, knees straight, torso upright, hips and shoulders in a neutral position. The participant's middle finger is used as the measurement point. During the measurement, the zero point of the measuring tape is placed in line with the middle finger.

    from enrollment and after 4 weeks

Secondary Outcomes (3)

  • endurance test

    from enrollment and after 4 weeks

  • Quality of life assessment

    From enrollment and after 4 weeks

  • Sleep quality

    from enrollment and after 4 weeks

Study Arms (2)

classical Massage

EXPERIMENTAL

Classical Massage Group

Other: Classical Massage

Manuel Therapy

ACTIVE COMPARATOR

Manuel Therapy Group

Other: Manual therapy

Interventions

Classical MassageOTHER

Classical Massage

classical Massage
Manual therapyOTHER

Manual therapy

Manuel Therapy

Eligibility Criteria

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

You may qualify if:

  • Being over 18 and being 65 years old
  • Those who have experienced thoracic back problems for at least 3 years
  • Being able to communicate in Turkish
  • Having reading and writing proficiency
  • To ensure voluntary interest in work
  • Being symptomatic and healthy
  • Those with functional scoliosis

You may not qualify if:

  • Being under 18 or 65 years old
  • Those with congenital and idiopathic scoliosis
  • Cases using cortisone in the last 6 weeks
  • Those who do not lie face down
  • History of traumatic injury to the Thoracic Spine
  • Those who have had spinal surgery
  • Those diagnosed with osteoporosis, bone tumor and rheumatoid
  • Pregnancy
  • Individuals with a history of neurological diseases (stroke, multiple sclerosis, Parkinson's)
  • History of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bigadic Saglikli Yasam Merkezi

Istanbul, 10000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

March 22, 2026

First Posted

April 9, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 10, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

TU(1)