Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial (HiLoBaS)

Regis University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Low Back Pain

Treatments: Procedure: Pragmatic low back pain treatment; Procedure: Prescriptive Hip Exercises and Manual Therapy techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT01900925

CC1937

Details and patient eligibility

About

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Full description

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). For inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of >2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. This finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. Exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators will track the outcomes of disability (Oswestry), Pain (Numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. Our aims are to determine if differences in groups exist, with our primary outcome measure of ODI. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Mechanically producible LBP.
• Minimum Modified Oswestry Disability Index score of 20%
• Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain

Exclusion criteria

• Presence of any red flags
• Signs consistent with nerve root compression
• Prior surgery to the lumbar spine
• Current pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Low back treatment only (pragmatic)

Active Comparator group

Description:

1. advise to stay active, 2. discourage bed rest, 3. appropriate medication use, 4. reassurance. 5. Short term use of manipulation/medication, 6. supervised exercise, 7. cognitive behavioral therapy, 8. multidisciplinary treatment, 9. termination of use of modalities.

Treatment:

Procedure: Pragmatic low back pain treatment

LBP treatment and Hip treatment

Experimental group

Description:

Group two will receive the same pragmatically applied, guideline-oriented treatment that is recommended from group 1. In addition, group 2 will receive prescriptive hip exercises that include 1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge, and the manual therapy treatment techniques of; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone.26 (See Appendix A for photos of the techniques and descriptions)

Treatment:

Procedure: Pragmatic low back pain treatment

Procedure: Prescriptive Hip Exercises and Manual Therapy techniques