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

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: Active, not recruiting
• Conditions: Radiculopathy Lumbar
• Intervention / Treatment: Diagnostic test: stability ball exercises; Diagnostic test: dead bug exercise; Combination product: Combined Groupo

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: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
SF-12 (Short Form 12-Item Health Survey)	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	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

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): July 10, 2024
• Study Completion (Estimated): March 2, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Radiculopathy; Low Back Pain
• Other Study ID 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