Clinical trial NCT03597191: Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Low Back Pain
Official title: Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Subacute and Chronic Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Low Back Pain
Subacute Low Back Pain
Keywords: Y-balance test
Functional Movement Screen
Spinal stabilization exercises
Dynamic balance
Postural control
Physical performance
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Texas Physical Therapy Association
First posted: 2018-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized clinical trial (RCT) using a prospective two-way (2 × 4) mixed-design to examine the effectiveness of spinal stabilization exercises (SSEs) on dynamic balance, functional performance, pain intensity, and disability level in adults with sub-acute and chronic low back pain (LBP).

The two independent variables are group, which is a between-subject factor, and time which is a within-subject factor. The independent variable of group has two levels: (1) the treatment group which will receive SSEs, and (2) the placebo group which will receive general range of motion and flexibility exercises.

The independent variable of time has four levels: pre-intervention at baseline, and two weeks, four weeks, and eight weeks after intervention.

The four dependent variables are (1) dynamic balance, (2) functional performance, (3) pain intensity, and (4) disability level.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change on dynamic balance
timeFrame: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
measure: Change on functional performance
timeFrame: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
measure: Change on pain intensity level
timeFrame: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
measure: Change on disability level
timeFrame: Change from baseline at two weeks, four weeks, and eight weeks post intervention.
Secondary outcomes:
measure: Fear-avoidance beliefs
timeFrame: at baseline and will be used for descriptive purposes only.
measure: Patient Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: at baseline and will be used for descriptive purposes only.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's UniversityT. Boone Pickens Institute of Health Sciences-Dallas Center
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Yousef M Alshehre, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Woman's University
name: Khalid M Alkhathami, MPT
role: PRINCIPAL_INVESTIGATOR
References: