Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain

NCT03527524 | Completed DMC

• 1 other identifier: MahidolU_Wunpen1
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.

Conditions

Exercise

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

• Pain scale

  a 0-100 mm of horizontal line (Visual analog scale) assessing pain intensity - reported the distance measured in millimeters from the left hand side of this line to the point that participant marked

  4 weeks

Secondary Outcomes (2)

• Questionnaire scores of functional disability measure

  4 weeks

• Levels of lumbar stability

  4 weeks

Study Arms (2)

exercise with ball

EXPERIMENTAL

The participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.

Other: exercise with ball

exercise without ball

OTHER

The participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.

Other: exercise without ball

Interventions

exercise with ball OTHER

exercise with ball

exercise with ball

exercise without ball OTHER

exercise without ball

exercise without ball

Eligibility Criteria

• Age: 20 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female with low back pain (LBP) \> 3 months
• Body mass index (BMI) = 18-25 kg/m2
• Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)
• Willing and able to perform exercise programs
• No cognitive impairment
• Age at least 19 years

You may not qualify if:

• Having experiences in the core stabilization exercise and Swiss ball exercises
• Past history of back and abdomen surgery
• Recent fractures of spine, hip or lower limb
• Current use of steroids or any other drugs for resolving back pain
• Red flags (fractures, cancer, infection, cauda equine syndrome)
• Pregnancy
• Neuromuscular or respiratory disorders
• Rheumatologic disorders
• Hip and knee stiffness
• Pain intensity \> 60 of 100 mm assessed by the VAS

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Apinkarn Jaroenlarp, MSc

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: May 17, 2018
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share