Thoracic Mobility Versus Hip Mobility Exercises to Core Stabilization in Lumbar Spondylitis (TME-HME)

November 3, 2026 updated by: YAHYA ABDU S KULAYBI, Cairo University

This study is conducted to determine the effect of thoracic mobility versus hip mobility exercises to core stabilization on pain severity (NPRS-Ar), functional disability (MODI-Ar), lumbar range of motion (BROM), spinal mobility (modified schober test), quality of life (SF-36-Ar) and fear of movement (Tampa-Ar) in treatment of patients with lumbar spondylitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

This study is conducted to determine the effect of thoracic mobility versus hip mobility exercises to core stabilization on pain severity

, functional disability , lumbar range of motion , spinal mobility , quality of life and fear of movement in treatment of patients with lumbar spondylitis.

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 (Actual)

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.
60

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

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

  • Egypt
      • Cairo, Egypt
        • Faculity Og Physical Therapy in Cairo Univercity

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. lumbar spondylitis diagnosis (symptoms will be more than 3 months) ..
  2. Patients' age from 40-60 years .
  3. Localized back pain and pain radiating to lower extremities

Exclusion Criteria:

  1. Spinal or hip surgery .
  2. pregnancy .
  3. Neurological Disorders: .
  4. Inflammatory Conditions: .
  5. Cognitive Impairment .

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: Core stabilization exercises (control group)

In the Core stabilization exercises (control group)patients will receive Core stabilization exercises as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session. The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition.
Behavioral: Group A : Core stabilization exercises (control group)

Core stabilization exercises include Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball In each session. The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, patients will be asked to maintain the neutral curvature of the lumbar spine, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition.
Experimental: Thoracic Mobility Exercises (1st experimental group only)

In the thoracic Mobility Exercises group ( experimental group B) will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to thoracic Mobility Exercises as (Thoracic extension with foam roller ,Thoracic extension with chair ,Thoracic flexion in quadruped , Right Thoracic rotation in side lying ,Left Thoracic rotation in side lying , Right kneeling Thoracic rotation , Left kneeling Thoracic rotation , Right Thoracic sitting lateral flexion and Left Thoracic sitting lateral flexion .Each exercise will be performed for 3 sets of 10 repetitions in addition to core stabilization program
Behavioral: Group B: Thoracic Mobility Exercises (1st experimental group only)

receive thoracic Mobility Exercises as movements in all directions of thoracic spine as (Thoracic extension with foam roller ,Thoracic extension with chair ,Thoracic flexion in quadruped , Right Thoracic rotation in side lying ,Left Thoracic rotation in side lying , Right kneeling Thoracic rotation , Left kneeling Thoracic rotation , Right Thoracic sitting lateral flexion and Left Thoracic sitting lateral flexion) .Each exercise will be performed for 3 sets of 10 repetitions.

Behavioral: GROUP B CORE STABILIZATION PROGRAM

will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition.
Experimental: Hip Mobility Exercises (2nd experimental group only)

will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to hip mobility exercises program The patients will perform 8 different hip mobility exercises; reverse v-ups, butterfly, frog, internal rotation with foot rise, pike, revolved crescent lunge, pigeon, lunge on the knee. Each exercise will be performed for 2 sets of 20 seconds.
Behavioral: Group C: Hip Mobility Exercises (2nd experimental group only)

will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to hip Mobility Exercises (The patients will perform 8 different hip mobility exercises; reverse v-ups, butterfly, frog, internal rotation with foot rise, pike, revolved crescent lunge, pigeon, lunge on the knee. Each exercise will be performed for 2 sets of 20 seconds).

Behavioral: GROUP C CORE STABILIZATION PROGRAM

will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition.

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
Change in Functional Disability Measured by the Modified Oswestry Disability Index (MODI-Ar)
Time Frame: Baseline and 6 weeks (post-treatment).

Functional disability caused by low back pain will be assessed using the Arabic version of the Modified Oswestry Disability Index (MODI-Ar).
Baseline and 6 weeks (post-treatment).
Change in Pain Intensity Measured by the Numerical Pain Rating Scale (NPRS-Ar)
Time Frame: Baseline and 6 weeks (post-treatment).

Pain intensity will be assessed using the Arabic version of the 11-point Numerical Pain Rating Scale (NPRS-Ar), ranging from 0 (no pain) to 10 (worst possible pain).
Baseline and 6 weeks (post-treatment).
Change in Active Lumbar Range of Motion Measured by the Back Range of Motion (BROM) Device.
Time Frame: Baseline and 6 weeks (post-treatment).

Active lumbar range of motion will be measured using the Back Range of Motion (BROM) device, including flexion, extension, right and left lateral flexion, and right and left rotation. Each movement will be measured over three trials, and the average value will be used for analysis.
Baseline and 6 weeks (post-treatment).
Change in Lumbar Flexion Mobility Measured by the Modified Schober Test.
Time Frame: Baseline and 6 weeks (post-treatment).

Lumbar flexion mobility will be assessed using the Modified Schober Test. Skin markings will be placed 15 cm above and 5 cm below the lumbosacral junction (L5-S1). The change in distance during forward trunk flexion will be recorded in centimeters.
Baseline and 6 weeks (post-treatment).
Change in Fear of Movement and Re-Injury Measured by the Tampa Scale for Kinesiophobia (TSK-Ar).
Time Frame: Baseline and 6 weeks (post-treatment).

Fear of movement and re-injury will be assessed using the Arabic version of the Tampa Scale for Kinesiophobia (TSK-Ar), which evaluates fear of movement and physical activity using a 4-point Likert scale.
Baseline and 6 weeks (post-treatment).
Change in Health-Related Quality of Life Measured by the RAND 36-Item Health Survey (RAND-36).
Time Frame: Baseline and 6 weeks (post-treatment).

Health-related quality of life will be assessed using the RAND 36-Item Health Survey, which evaluates physical functioning, emotional well-being, social functioning, and other health-related domains. Each domain is scored from 0 to 100, with higher scores indicating better health status.
Baseline and 6 weeks (post-treatment).

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.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MOAAZ R EL SAKKA, PhD, CAIRO UNIVERCITY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 25, 2026

Primary Completion (Actual)

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.
June 29, 2026

Study Completion (Actual)

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.
July 30, 2026

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 16, 2026

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 16, 2026

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 19, 2026

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.
November 5, 2026

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.
November 3, 2026

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.
November 1, 2026

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.
  • P.T.REC/012/006229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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