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Completed

NCT Number: NCT00830596

Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palmer College of Chiropractic

Davenport, Iowa, 52803, United States

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HVLA-SM

Other

High velocity, low amplitude lumbo-pelvic manipulation

LVVA-SM

Other

Low velocity, variable amplitude lumbo-pelvic manipulation

Sham intervention

Other

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

Other names: light effleurage followed by SMT

Primary outcomes

  1. Postural Sway

    Time frame: 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.

  2. Postural Sway Speed

    Time frame: 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.

  3. Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL

    Time frame: 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

  4. Response to Sudden Load, Peak Muscle Response Per Side

    Time frame: 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)

  5. Response to Sudden Load Response Times

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Palmer College of Chiropractic

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: D2P3

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2009
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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