Clinical trial NCT06749574: Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain
Official title: Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Radiculopathy Lumbar
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 12 Months
measure: SF-12 (Short Form 12-Item Health Survey)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayed Hosp and Alara Health Care Clinic
state: Punjab
Study officials:
References: