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

Not Applicable

Active, not recruiting

• Conditions: Radiculopathy Lumbar

• Registration Number: NCT06749574
• Lead Sponsor: Superior University

Brief Summary

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.

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 Timeline

• Study Start: 2024-02-15
• Primary Completion: 2024-07-10
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-01
• Last Update Posted: 2025-02-04
• Study Completion: 2025-03-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	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.
SF-12 (Short Form 12-Item Health Survey)	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.

Trial Locations

Locations (1)

Sheikh Zayed Hosp and Alara Health Care Clinic; 🇵🇰 Lahore, Punjab, Pakistan