Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Low Back Pain

NCT ID: NCT03597191

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2018-11-11

Brief Summary

The investigators would like to know which one of two exercise programs will have a greater effect on balance, functional performance, daily function, and pain on individuals with low back pain (LBP) after 2, 4 and 8 weeks.

Specifically, the differences in dynamic balance, functional performance, pain intensity, and disability level will be compared between participants who receive spinal stabilization exercises program (SSE) and those who receive a general exercise program (GE) which includes range-of-motion (ROM) and flexibility exercises.

The research hypotheses are:

1. The SSE program will significantly improve dynamic balance and functional performance in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention.

2. The SSE program will significantly improve pain intensity and disability level in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention.

3. In adult participants with sub-acute and chronic LBP, the group receiving the SSE program will demonstrate significantly improved dynamic balance, functional performance, pain intensity and disability levels compared to the placebo group receiving the GE program at two and four weeks as well as after an eight-week follow-up after initiating intervention.

Detailed Description

Participants will be required to wear a pair of shorts, a loose T-shirt, and a pair of tennis shoes for this study. On the first visit, the investigators will do some tests to make sure that potential participant has good feeling and strength in his/her legs. Next, each participant will fill out a few forms asking about daily function and back pain. Then, the investigators will ask the participant to perform a balance test and seven functional tests. Two investigators will be there to give these tests.

During the balance test, each participant will stand on one leg and reach out for a distance with the other leg. During the functional tests, the participant will perform 7 different tasks, including a deep squat, hurdle step, in-line lunge, shoulder mobility, active straight leg raise, rotary stability and trunk stability push-up. The investigators will demonstrate these tests before the participant perform them.

After the balance and functional tests, each participant will be randomly assigned to one of the exercise programs. One of the investigators will instruct each participant to do the appropriate exercises depending on his/her ability and pain level.

After the first visit, participants will be asked to come back 1-2 times per week for 4 weeks so the investigators can update participants' exercise program and make sure that participants do each exercise in the correct form. Each follow-up visit will take about 30 minutes. In addition to the physical therapy visits, the investigators will ask participants to do the most updated exercises at home once a day and at least 5 times a week. The investigators will give each participant an exercise log to track the frequency of the home exercise sessions. At the end of the 4 weeks, participants will come to the last physical therapy session and will be asked to continue to do the updated exercises at home once a day and at least 5 times a week for another 4 weeks until the 8-week follow-up visit.

At the 2-week, 4-week and 8-week follow-up visit, the investigators will repeat the balance and the 7 functional tests.

Each testing session will last about 30 minutes. The testing sessions at 2 and 4 weeks will be done on the same visit of physical therapy for the participants' exercise sessions. During the 8-week follow-up visit, the investigators will ask the participants to fill out the forms about their daily function and back pain in addition to the balance and 7 functional tests. At the end of the 8 weeks, if the participants wish to have the other exercises, the investigators will instruct them with those exercises.

Conditions

Low Back Pain; Chronic Low Back Pain; Subacute Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Spinal Stabilization Exercise Program

Participants in the spinal stabilization exercise group will be instructed to perform four exercises in total, one exercise from each of the following four categories: (a) abdominal bracing, (b) quadruped, (c) prone plank, and (d) side plank exercises. Each exercise will be progressed and advanced in difficulty by increasing repetitions, hold times, and/or extremity movements.

The progression of exercises will be based on the participants' performance at each supervised physical therapy session based on pre-established criteria by Hicks et al. (2005).

Group Type: EXPERIMENTAL

Exercises

Intervention Type: OTHER

Participants in the treatment group will be instructed in the spinal stabilization exercises (SSEs), modeled after the spinal stabilization exercise program designed by Hicks et al. (2005). The SSE program targets muscle activation of spinal stabilizers specifically, the transversus abdominus and lumbar multifidus muscles. Each exercise will be progressed by increasing repetitions and hold time.

General Exercises Program

Participants in the general exercise group will perform a range of motion (ROM) and flexibility exercises of low back and lower extremities. Each participant will be instructed to perform four exercises in total, one exercise from each of the following four categories: (a) knee to chest, (b) lower trunk rotation, (c) prone press-ups, and (d) hamstring stretch exercises. These exercises will be progressed by increasing repetitions and pain-free ROM.

Group Type: PLACEBO_COMPARATOR

Exercises

Intervention Type: OTHER

Participants in the treatment group will be instructed in the spinal stabilization exercises (SSEs), modeled after the spinal stabilization exercise program designed by Hicks et al. (2005). The SSE program targets muscle activation of spinal stabilizers specifically, the transversus abdominus and lumbar multifidus muscles. Each exercise will be progressed by increasing repetitions and hold time.

Interventions

Exercises

Participants in the treatment group will be instructed in the spinal stabilization exercises (SSEs), modeled after the spinal stabilization exercise program designed by Hicks et al. (2005). The SSE program targets muscle activation of spinal stabilizers specifically, the transversus abdominus and lumbar multifidus muscles. Each exercise will be progressed by increasing repetitions and hold time.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals between the age of 18 to 65 years

2. Individuals who have low back pain (LBP) for 6 weeks or more

3. ability to understand, speak, and follow verbal instructions in English

4. the average pain level of at least 2 out of 10 in the past week

Exclusion Criteria

1. serious spinal conditions such as fracture, infection, or tumor

2. signs of nerve root compression

3. a history of lower extremity or lumbar spine surgery

4. a history of hip, knee, or ankle pain in the previous two years

5. current pregnancy

6. systemic joint disease (e.g. rheumatologic or neurological disorders)

7. vestibular or other balance disorders

8. ongoing treatment for inner ear, sinus, or upper respiratory infection

9. concussion within the previous three months

10. a history of falls or fear of falling

11. a need for any form of walking aids (cane, walker)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Physical Therapy Association

OTHER

Sponsor Role: collaborator

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Yousef Alshehre

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yousef M Alshehre, MSc.

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Khalid M Alkhathami, MPT

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

Texas Woman's UniversityT. Boone Pickens Institute of Health Sciences-Dallas Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

19982

Identifier Type: -

Identifier Source: org_study_id