Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830596

Acronym

D2P3

Enrollment

221

Registered

2009-01-28

Start date

2007-07-31

Completion date

2012-07-31

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief summary

The long-term goal for this study is to understand the physiological mechanisms of various forms of spinal manipulation in order to refine and improve this therapy for appropriately selected patients. The objective of this study is to assess the effects of high-velocity low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on three types of sensorimotor abilities in patients with low back pain.

Detailed description

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pursue the following specific aim: To determine the effects of 2 weeks (4 applications @ 2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as measured by: lumbo-pelvic repositioning ability, standing postural sway and response to sudden trunk loading;

Interventions

OTHERHVLA-SM

High velocity, low amplitude lumbo-pelvic manipulation

OTHERLVVA-SM

Low velocity, variable amplitude lumbo-pelvic manipulation

OTHERSham Intervention

2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 21 to 65 years old * Low back pain (LBP) score an 11 point numerical rating scale: (must be \> 4 at the Phone Screening OR Baseline 1 Visit) AND (must be \> 2 at the Phone Screen, Baseline 1 AND Baseline 2 Visits) * Acute (less than 7 days), sub-acute (7 days to 7 weeks), or chronic (more than 7 weeks) LBP matching classifications 1, 2, or 3 of the Quebec Task Force (QTF) Classification system - QTF 1: Pain without radiation, QTF 2: Pain + radiation to proximal extremity, QTF 3: Pain + radiation to distal extremity, QTF 7: Spinal stenosis * Written informed consent (ICD1, ICD2 and ICD3)

Exclusion criteria

* Ongoing treatment for low back pain by other health care providers - unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy and massage) for the duration of the study period. * Co-morbidities Bleeding Disorders Bone and Joint Pathology Cauda Equina Syndrome Contra-indication to spinal manipulation, in general Current or Pending Litigation General Poor Health Inflammatory or Destructive tissue changes to the spine Neuromuscular Diseases Obesity Osteoporosis Peripheral Neuropathies Spinal Surgery Suspicion of drug or alcohol abuse Uncontrolled hypertension Vascular claudication * Quebec Task Force (QTF) on Spinal Disorders QTF 4: Pain + radiation to upper/lower limb with neurologic signs QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques QTF 8: Postsurgical status, 1-6 months after intervention QTF 9: Postsurgical status, \>6 months after intervention 9.1: Asymptomatic 9.2: Symptomatic QTF 10: Chronic pain syndrome QTF 11: Other diagnoses * Pregnant or nursing women * Pacemaker * Inability to read or verbally comprehend English * Any Joint Replacement * Use of spinal manipulation within the past 4 weeks. If participants are willing to delay study enrollment until four weeks post spinal manipulative therapy, then we will schedule accordingly until this criterion is met * Sensitivity to tape used during the biomechanical assessments * If the Study Clinician believes that diagnostic procedures other than x-rays or dipstick urinalysis are necessary to diagnose a participant's condition, then the participant will be excluded * Beck Depression Inventory-II greater than or equal to 29 * Retention of legal advice and an open or pending case for a health-related condition

Design outcomes

Primary

Measure	Time frame	Description
Postural Sway	Baseline and 2 weeks	Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.
Postural Sway Speed	Baseline and 2 weeks	Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Sway Speed=overall center of pressure traveling distance divided by time.
Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL	Baseline and 2 weeks	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load \[RTSL\], ant. COP=anterior movement in center of pressure
Response to Sudden Load, Peak Muscle Response Per Side	Baseline and 2 weeks	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load \[RTSL\] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)
Response to Sudden Load Response Times	Baseline and 2 weeks	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load \[RTSL\] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)

Countries

United States

Participant flow

Recruitment details

Participants with acute, subacute, or chronic low back pain were recruited from local communities.

Participants by arm

Arm	Count
HVLA-SM High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation	74
LVVA-SM Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation	74
Sham Intervention Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation	73
Total	221

Baseline characteristics

Characteristic	HVLA-SM	LVVA-SM	Sham Intervention	Total
Age, Continuous	44.1 years STANDARD_DEVIATION 10.6	44.5 years STANDARD_DEVIATION 10.2	44.4 years STANDARD_DEVIATION 10.5	44.3 years STANDARD_DEVIATION 10.4
Sex: Female, Male Female	34 Participants	34 Participants	33 Participants	101 Participants
Sex: Female, Male Male	40 Participants	40 Participants	40 Participants	120 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 74	0 / 74	0 / 73
other Total, other adverse events	50 / 74	57 / 74	46 / 73
serious Total, serious adverse events	0 / 74	0 / 74	0 / 73

Outcome results

Primary

Postural Sway

Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.