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

NCT03597191 | Completed

• 1 other identifier: 19982
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• Change on dynamic balance

  Dynamic balance measured by the Y-balance Test (YBT). Dynamic balance is quantified by measuring how far the reach indicator is placed relative to the stance platform while maintaining a unilateral stance. A farther reach distance is indicative of greater dynamic balance. To score each of the three directions, the reach distances (measured in cm) are averaged and normalized to the participant's leg length. As such, YBT scores are expressed as a percentage of leg length. Normalization is performed by dividing each reach distance by the participant's leg length and then multiplying by a hundred. Next, the composite score will be calculated by taking the average between right and left reach distances for all three directions and then summing the averages of the three reach directions. The score then will be divided by three times the average leg length and multiplied by 100.

  Change from baseline at two weeks, four weeks, and eight weeks post intervention.

• Change on functional performance

  Functional performance measured by Functional Movement Screen (FMS). Each participant will perform all 7 components of the FMS tests including deep squat, hurdle step, in-line lunge, shoulder mobility, active straight-leg-raise, trunk push-up, and trunk rotary stability tests. Participants will perform 3 trials for each of the 7 FMS tests, and the best score from the 3 trials will be recorded. In addition, each participant will perform 3 clearance screens. These 3 clearance screens evaluate pain and are graded as negative or positive. If a participant has no pain, the clearing test is considered negative. If there is an increase in pain, the clearing test is considered positive and the associated test will be scored zero. For movements that are scored on both limbs, the lower score will be used to compute the composite score. The total score of the 7 tests will be added together to get a composite score of the FMS.

  Change from baseline at two weeks, four weeks, and eight weeks post intervention.

• Change on pain intensity level

  pain intensity as perceived by the participant measured by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point numerical scale (0-10), in which higher scores mean greater pain intensity. The possible scores on the NPRS range from zero representing no pain to 10 representing the worst imaginable pain. The NPRS will be administered verbally, and each participant will be asked to rate their pain intensity at present (i.e. current pain level).

  Change from baseline at two weeks, four weeks, and eight weeks post intervention.

• Change on disability level

  Modified Oswestry Low Back Pain Disability Questionnaire (OSW) to determine participants perceived disability level due to low back pain. The OSW is a self-reported ordinal scale measure that consists of 10 items assessing different aspects of pain and function related to the patient's LBP. Each item is scored on a six-point scale (0 to 5), with five representing the highest level of disability. The scores of the 10 items are then summed, with a maximum possible sum of 50 points. To obtain a percentage score, the sum is multiplied by two. Participants will be asked to use the OSW to rate their perceived level of disability at present.

  Change from baseline at two weeks, four weeks, and eight weeks post intervention.

Secondary Outcomes (2)

• Fear-avoidance beliefs

  at baseline and will be used for descriptive purposes only.

• Patient Reported Outcomes Measurement Information System (PROMIS-29)

  at baseline and will be used for descriptive purposes only.

Study Arms (2)

Spinal Stabilization Exercise Program

EXPERIMENTAL

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).

Other: Exercises

General Exercises Program

PLACEBO COMPARATOR

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.

Other: Exercises

Interventions

Exercises 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; Spinal Stabilization Exercise Program

Eligibility Criteria

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

You may qualify if:

• Individuals between the age of 18 to 65 years
• Individuals who have low back pain (LBP) for 6 weeks or more
• ability to understand, speak, and follow verbal instructions in English
• the average pain level of at least 2 out of 10 in the past week

You may not qualify if:

• serious spinal conditions such as fracture, infection, or tumor
• signs of nerve root compression
• a history of lower extremity or lumbar spine surgery
• a history of hip, knee, or ankle pain in the previous two years
• current pregnancy
• systemic joint disease (e.g. rheumatologic or neurological disorders)
• vestibular or other balance disorders
• ongoing treatment for inner ear, sinus, or upper respiratory infection
• concussion within the previous three months
• a history of falls or fear of falling
• a need for any form of walking aids (cane, walker)

Sponsors & Collaborators

• Texas Woman's University: lead
• Texas Physical Therapy Association: collaborator

Study Sites (1)

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

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yousef M Alshehre, MSc.

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

• Khalid M Alkhathami, MPT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The primary investigator (PI) of this study, the outcomes assessor, will be blinded to participants' group assignment and will perform the eligibility screening and standard physical therapy examination for all participants. In addition, the PI will perform the pre- and post-intervention measurements of dynamic balance using the Y- balance test, functional performance using Functional Movement Screen, pain scores using the Numeric Pain Rating Scale, and disability levels using the Modified Oswestry Low Back Pain Disability Questionnaire. Investigator #2, the care provider, will be blinded to the outcomes measurements and will be responsible for group allocation and administering the intervention, either a spinal stabilization exercises program or a general exercises program, to participants in both groups. Participants will be randomly assigned to one of the two study groups and will be blinded to the other group exercise program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 24, 2018
• Study Start: June 25, 2018
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)