Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain

February 1, 2025 updated by: Muhammad Naveed Babur, Superior University
This study is a single-blinded, randomized controlled trial (RCT) focused on individuals aged 30 to 50 with acute specific low back pain (lumbar radiculopathy). Participants will be divided into three groups: one performing stability ball exercises, one doing dead bug exercises, and the third group combining both types of exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

The study aims to assess the effectiveness of these regimens in reducing pain and improving quality of life. The trial will be conducted at Sheikh Zayed Hospital and Alara Health Care Clinic, with simple random sampling used to assign participants. The study will run for 6 months, with follow-up assessments at 1, 4, and 8 weeks.

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.
63

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Sheikh Zayed Hosp and Alara Health Care Clinic

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • participants aged 30 to 50 years with a specific diagnosis of acute lumbar radiculopathy lasting less than three months but severe enough to impair daily activities were included in the study.
  • They were required to provide informed consent and agree to adhere to the study procedures,
  • including attending sessions and completing evaluations. Eligibility was limited to those without other physical conditions, such as joint replacements or fractures,
  • that could interfere with the ability to perform stability ball or dead bug exercises. Individuals who had participated in similar therapeutic exercises, such as stability ball training or core strengthening, within the last six months were excluded to ensure the results reflected the intervention's impact rather than prior training effects.

Exclusion criteria:

  • included participants with severe musculoskeletal or cardiovascular disorders, such as spinal surgery, herniated discs, scoliosis, fractures, or osteoarthritis, due to the potential risks associated with exercise.
  • Pregnant women were excluded as balance-related activities, like stability ball exercises, could pose safety concerns. Individuals using pain medications, particularly opioids or muscle relaxants, were excluded to avoid interference with exercise performance or altered pain perception.
  • Participants who had undergone back surgery within the last six months, or those currently undergoing other physical therapy or treatments for back pain, such as physiotherapy or chiropractic care, in the previous month were also excluded

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Stability ball Training
Diagnostic test: stability ball exercises
articipants in the first group performed stability ball exercises designed to enhance balance, core stability, they were introduced to the stability ball with instructions on maintaining proper posture, alignment, and safety to prevent injuries. The program included exercises such as the Stability ball bridging, stability ball bird dog and stability ball pelvic tilts were included to activate the lower abdominal muscles and glutes through gentle, controlled movements
Experimental: Dead bug training:
Diagnostic test: dead bug exercise
The second group focused on dead bug exercises, Participants performed exercises such as extending one arm and the opposite leg while lying on their backs, ensuring their spine remained neutral and their lower back stayed pressed into the floor. Variations included alternating opposite arm and leg movements and holding the extended position to increase the challenge and enhance core stability. These exercises were performed slowly to maintain control and improve movement precision over the eight-week period
Active Comparator: Combined Group
Combination product: Combined Groupo
The third group combined stability ball and dead bug exercises for a comprehensive training approach targeting both core stability and balance. Participants alternated between dead bug exercises, which required controlled arm and leg extensions while lying on their backs, and stability ball exercises such as the ball with bridging and bird dog. Throughout the eight weeks, participants were encouraged to maintain proper posture, alignment, and a neutral spine during all activities to ensure safety and effectiveness

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
SF-12 (Short Form 12-Item Health Survey)
Time Frame: 12 Months
widely used questionnaire designed to assess health-related quality of life. It is a concise version of the SF-36, retaining 12 carefully selected questions that measure physical and mental health domains. The SF-12 evaluates eight health components: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional health problems, and mental health.Responses from the SF-12 are used to generate two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores provide a quantitative measure of an individual's physical and mental well-being, respectively. The PCS focuses on physical health aspects like mobility and pain, while the MCS emphasizes emotional health and social functioning.
12 Months
Visual Analog Scale
Time Frame: 12 Months
The VAS (Visual Analog Scale) is used for pain assessment. It consists of a vertical line, with the words 'No pain' at the bottom end corresponding to a VAS of 0, and 'Worst pain possible' at the top end corresponding to a VAS of 10.
12 Months

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.
Superior 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 (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.
February 15, 2024

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.
July 10, 2024

Study Completion (Estimated)

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 2, 2025

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).
December 19, 2024

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.
December 19, 2024

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 25, 2025

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 25, 2025

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.
February 1, 2025

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.
February 1, 2025

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.
  • MSRSW/Batch-Fall22/774

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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