Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality

April 2, 2026 updated by: Ayşe BAŞAYAN
Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 10000
        • Bigadic Saglikli Yasam Merkezi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: classical Massage
Classical Massage Group
Other: Classical Massage
Classical Massage
Active Comparator: Manuel Therapy
Manuel Therapy Group
Other: Manual therapy
Manual therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment
Time Frame: From enrollment and after 4 weeks
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
Time Frame: From enrollment and after 4 weeks
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
Time Frame: From enrollment and after 4 weeks

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
Time Frame: from enrollment and after 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
endurance test
Time Frame: from enrollment and after 4 weeks

The dynamic sit-up test is used to assess the endurance of the trunk flexor muscles of the participants, and the trunk extensor muscle endurance test is used to assess trunk extensor muscle endurance.

In these measurements, the number of repetitions completed by the participants in 60 seconds is noted.
from enrollment and after 4 weeks
Quality of life assessment
Time Frame: From enrollment and after 4 weeks
The Short Form-36 will assess mental and physical health. This form will examine participants' physical and mental health status across eight sub-dimensions. Quality of life will be assessed through eight sub-dimensions: physical function, social function, physical role difficulty, emotional role difficulty, mental health, vitality, body pain, and general health.
From enrollment and after 4 weeks
Sleep quality
Time Frame: from enrollment and after 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) will be used as a valid and reliable assessment tool to provide information about participants' sleep quality, as well as the type and severity of sleep disturbances over the past month. The scale will consist of 19 self-reported items and 7 sub-dimensions. In this measure, the following parameters will be evaluated: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item on the scale will be scored between 0 and 3.
from enrollment and after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayşe BAŞAYAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 10, 2026

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İRU-FTR-AB-01
  • Istanbul Rumeli University (Other Identifier: Istanbul Rumeli University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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