CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Lumbar Manipulation +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02111278
NCT02111278N/ACompleted

Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial

Nationwide Children's Hospital·interventional·Posted Apr 11, 2014·Updated Dec 23, 2014

In Brief

A clinical study evaluating Lumbar Manipulation, Sham Manipulation, and 1 other intervention for Low Back Pain. Completed, enrolled 35 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2014
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.2 years ago

Interventions

Lumbar Manipulationother

The manipulating therapist performs the lumbar manipulation technique. With the patient supine, the therapist stands opposite the side to be manipulated. The patient is passively side-bent away from the therapist. The therapist rotates the thoracic spine and then delivers a quick posterior and inferior thrust through the anterior superior iliac spine. The manipulation is performed on the side the patient reported to be more symptomatic. If the patient is unable to identify a more painful side, the side to be manipulated is left to the manipulating therapist discretion. If a cavitation is experienced, no more manipulations are performed that session. If no cavitation is produced, the patient is repositioned, and the manipulation is attempted again. If no cavitation is experienced again, the therapist attempts to manipulate the opposite side. A maximum of two attempts per side will be attempted.

Sham Manipulationother

The manipulating therapist will perform the sham lumbar manipulation technique with the patient side-lying. The therapist passively flexes both hips until slight lumbar flexion is noted at the patient's most painful vertebral level. The therapist will take time palpating patient's spine taking care to avoid rotating the spine. The therapist will then place both hands on the same lumbar spinous process. An equal and opposite force is then applied to the spinous process with both hands. No physiologic motion is expected with this technique. The patient will then be setup for the same sham technique on the opposite side. The sham manipulation technique will be performed in an attempt to blind the patient to group allocation. This technique is designed to provide similar hands on treatment time as the manipulation intervention.

Physical Therapyother

Patients will receive 4 weeks of physical therapy with 2 visits per week. The treating physical therapist is blinded to group allocation. The treating physical therapist will prescribe exercises based on patient presentation. Therapy visits last approximately 45-60 minutes depending of patient ability to perform exercises. The treating physical therapist will perform no mobilizations or manipulations on the patient.