NCT06749574

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

December 19, 2024

Last Update Submit

February 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Stability ball Training

ACTIVE COMPARATOR
Diagnostic Test: stability ball exercises

Dead bug training:

EXPERIMENTAL
Diagnostic Test: dead bug exercise

Combined Group

ACTIVE COMPARATOR
Combination Product: Combined Groupo

Interventions

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

Stability ball Training
dead bug exerciseDIAGNOSTIC_TEST

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

Dead bug training:
Combined GroupoCOMBINATION_PRODUCT

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

Combined Group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Hosp and Alara Health Care Clinic

Lahore, Punjab Province, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

February 15, 2024

Primary Completion

July 10, 2024

Study Completion

March 2, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations