Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain

March 3, 2023 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain is one of the most common problems in society, experienced by 70-80% of individuals at least once in their lifetime. Physical pain can cause serious functional losses that affect independence in daily life. In patients with low back pain, physical endurance decreases because of pain, spasm, decrease in muscle strength and deteriorated posture, and the functional capacity and quality of life of the patient are negatively affected. While most individuals recover spontaneously, 2-8% of them require medical treatment, and the response to conservative treatment is generally good. Along with medical treatment, different physiotherapy methods (electro-physical agents, massage, traction, exercises, etc.), which are conservative treatment methods, are also frequently used. It is known that classical physiotherapy modalities (heating agents and exercise approaches) have an important place in the treatment of these patients due to their positive effects on pain, strength, flexibility and functionality. Massage is used to systematically manipulate the soft tissues of the body with rhythmic pressure and to provide or maintain health. Basically, massage is a simple way to provide pain relief through physical and mental relaxation. It is thought to relieve pain in various ways, including increasing the pain threshold by secreting endorphins and closing the pain gate at the spinal cord level. Classical massage is considered rehabilitative and is also used to reduce symptoms associated with medical conditions. It has been reported that classical massage reduces many physical and psychological symptoms in different musculoskeletal problems (neck pain, fibromyalgia, etc.). However, there is a need for placebo-controlled studies in the literature examining the effects of classical massage in individuals with chronic low back pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Group 1 will be applied classical physiotherapy and classical massage
Other: Classical physiotherapy and classical massage
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.
Placebo Comparator: Group 2
Group 2 will be applied classical physiotherapy and placebo massage
Other: Classical physiotherapy and placebo massage
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: change from baseline at 3 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spinal mobility
Time Frame: change from baseline at 3 weeks
Spinal mobility will be assessed with the Modified Shober test. With the patient in an upright position, a mark will be made at the midpoint of the imaginary line joining the posterior superior iliac spine on the back. Another mark will be made 10 cm above and 5 cm below this mark. The patient will be asked to lean forward maximally, keeping the knees fully extended. The distance between these marks will be measured. Mobility will be recorded by calculating the difference between the upright and maximum flexion end positions. It is stated that the greater the difference, the greater the mobility.
change from baseline at 3 weeks
Functional status
Time Frame: change from baseline at 3 weeks
Functional status will be assessed with the Oswestry Disability Index (ODI) . The index consists of 10 items (pain severity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, travel) and is scored on a 0-5-point scale based on functional performance. Higher scores indicate more severe disability.
change from baseline at 3 weeks
Psychological state
Time Frame: change from baseline at 3 weeks

Psychological state will be evaluated using the Hospital Anxiety Depression Scale. The scale has 14 items, 7 of which with odd numbers represent anxiety while the other 7 with even numbers represent depression.

Higher scores indicate more severe anxiety or depression.
change from baseline at 3 weeks
Life quality
Time Frame: change from baseline at 3 weeks
Life quality will be evaluated with the Short Form (SF-36) consisting of 36 items. It includes eight different fields: general health, bodily pain, physical function, physical and mental role limitations, mental health, vitality, and social function. The eight fields can be join mainly the physical component summary and the mental component summary that reflects physical and mental health. While '100' is the best score the '0' is the worst and higher scores indicate better life quality.
change from baseline at 3 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/03/04

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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