Lumbar Extension Strengthening in Addition to Manual Therapy and Exercise for Chronic Low Back Pain

NCT07719452 | Enrolling By Invitation

• 1 other identifier: C.2026.044d / eIRB #992009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises (standard therapy) in adults with chronic low back pain (cLBP). Researchers will compare individuals with cLBP that receive lumbar extensor strengthening in addition to standard therapy compared to standard therapy alone to determine if there are differences in patient reported outcomes, lumbar multifidus thickness, low back endurance, and healthcare utilization between the groups. All participants will engage in 8-weeks of physical therapy, receiving manual therapy and motor control exercises. Those in the intervention group will have additional low back strengthening exercises.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

Physical Therapy; Manual Therapy; Motor Control Exercise; Lumbar Strengthening

Outcome Measures

Primary Outcomes (1)

• Modified Oswestry Disability Index (mODI)

  A 10-item disability questionnaire administered to evaluate the patient's symptoms and the functional impact of low back pain. Each item is scored on a 0-5 Likert scale. The total score is converted to a 0-100% disability index, with 0% indicating no functional limitation and 100% representing complete disability or a bedbound state.

  Enrollment, 4, 8, 12, and 26-weeks

Secondary Outcomes (6)

• PROMIS-29

  Enrollment, 4, 8, 12, and 26-weeks

• Lumbar Spine Instability Questionnaire (LSIQ)

  Enrollment

• Patient Acceptable Symptom State (PASS)

  Enrollment, 4, 8, 12, and 26-weeks

• Healthcare Utilization

  Enrollment, 4, 8, 12, 26-weeks

• Lumbar Multifidus Thickness: L4-L5, L5-S1 bilaterally

  Enrollment, 8, and 12-weeks

Study Arms (2)

Standard Physical Therapy

ACTIVE COMPARATOR

Other: Standard Physical Therapy

Standard Physical Therapy Plus Lumbar Extensor Strengthening

EXPERIMENTAL

Other: Lumbar Extensor Strengthening plus Standard Physical Therapy

Interventions

Standard Physical Therapy OTHER

Participants randomized to the SPT group (control group) will receive pragmatic treatments of manual therapy and motor control exercises (MCE) based on their clinical presentation, which is consistent with standard patient care management of chronic lower back pain. They will attend a total of 10-14 visits over a course of 8 weeks, as is typical for routine care of individuals with cLBP. The treating physical therapist will use manual therapy and motor control exercise interventions that will be tailored to the patient's individual presentation.

Also known as: Manual Therapy, Motor Control Exercise

Standard Physical Therapy

Lumbar Extensor Strengthening plus Standard Physical Therapy OTHER

Participants randomized to the SPT+LEX group (experimental group) will receive the same pragmatic treatments of manual therapy and MCE as the control group over the same number of visits (10-14). In addition to MCE and manual therapy, this group will perform specific lumbar extensor strengthening. These exercises target the lumbar extensor muscle group (to include the lumbar multifidus) and may be performed by lying prone on the edge of a bench or mat and lifting the legs to parallel while the torso is stabilized. Alternatively, they may be performed by stabilizing the hips and legs while lifting the torso to varying angles from horizontal with or without weights.

Standard Physical Therapy Plus Lumbar Extensor Strengthening

Eligibility Criteria

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

You may qualify if:

• Tricare Beneficiary
• years old
• LBP ≥ 3 months without symptoms below the knee
• mODI ≥ 24%
• English speaking
• Available to actively take part in the study for 12 weeks

You may not qualify if:

• History of spine surgery or expecting spinal surgery
• Suspected or confirmed serious pathology (infection, cancer, fracture, cauda equina)
• Diagnosis of any vertebral fracture in the last 6 months
• Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates
• History of any bone-related cancer or cancer that metastasized to the bone
• Diagnosed rheumatological or inflammatory disease
• Progressive neurological disease
• Leg pain as the primary complaint (radiculopathy, peripheral vascular disease, stenosis)
• Contraindications to exercise and manual therapy
• Currently pregnant, self-reported or post-partum within the past 6 months
• Received physical therapy treatment for LBP in the past 6 months
• In the last 3 months, received injections, nerve ablation or blocks or is seeking such services
• Uncontrolled drug/alcohol addiction
• Currently under litigation related to cLBP
• Pending or expecting a Medical Evaluation Board (MEB)

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

CPT Jennifer Moreno Primary Care Clinic - Physical Therapy

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (6)

• Zafereo J, Wang-Price S, Roddey T, Brizzolara K. Regional manual therapy and motor control exercise for chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2018;26(4):193-202. doi:10.1080/10669817.2018.1433283

  BACKGROUND

• Dos Santos ECS, Dos Santos AT, da Silva NA, Carneiro SR, Rampazo EP, Magalhaes MO. Effectiveness of adding manual therapy to exercise for pain and disability in chronic non-specific low back pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2026 Apr;82:103508. doi: 10.1016/j.msksp.2026.103508. Epub 2026 Jan 30.

  PMID: 41643247 BACKGROUND

• Winder B, Keri PA, Weberg DE, Beneck GJ. Postural cueing increases multifidus activation during stabilization exercise in participants with chronic and recurrent low back pain: An electromyographic study. J Electromyogr Kinesiol. 2019 Jun;46:28-34. doi: 10.1016/j.jelekin.2019.03.005. Epub 2019 Mar 9.

  PMID: 30878650 BACKGROUND

• Fortin M, Rye M, Roussac A, Montpetit C, Burdick J, Naghdi N, Rosenstein B, Bertrand C, Macedo LG, Elliott JM, Dover G, DeMont R, Weber MH, Pepin V. The Effects of Combined Motor Control and Isolated Extensor Strengthening versus General Exercise on Paraspinal Muscle Morphology, Composition, and Function in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2023 Sep 12;12(18):5920. doi: 10.3390/jcm12185920.

  PMID: 37762861 BACKGROUND

• Cheng M, Xue Y, Cui M, Zeng X, Yang C, Ding F, Xie L. Global, Regional, and National Burden of Low Back Pain: Findings From the Global Burden of Disease Study 2021 and Projections to 2050. Spine (Phila Pa 1976). 2025 Apr 1;50(7):E128-E139. doi: 10.1097/BRS.0000000000005265. Epub 2025 Jan 22.

  PMID: 39838749 BACKGROUND

• Cashin AG, Chou R, Weimer MB, McAuley JH. Low Back Pain: A Review. JAMA. 2026 Jul 14;336(2):144-158. doi: 10.1001/jama.2026.9631.

  PMID: 42295944 BACKGROUND

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Benjamin Hando, PT, DSc, PhD

  Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)