PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Study

NCT01842737 | Completed DMC

• 1 other identifier: PRoGReSS-PS
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure back pain perceptions in participants who receive either chiropractic treatment or foot massage. The study will also measure back pain and function with research questionnaires and other measures.

Conditions

Low Back Pain

Keywords

Low Back Pain; Chiropractic; Spinal Manipulation; Massage

Outcome Measures

Primary Outcomes (1)

• Back Pain Visual Analogue Scale

  The Back Pain Visual Analogue Scale (VAS) has excellent metric properties, is easy to administer and score, and is commonly used in LBP research. Our anchors will be no pain to worst pain imaginable and use the average of 3 VAS questions: worst LBP in the last 24 hours; least LBP in the last 24 hours; and average LBP in the last 24 hours.

  4 Weeks

Secondary Outcomes (4)

• Roland Morris Disability Questionnaire

  4 Weeks

• Two-Point Discrimination

  4 Weeks

• Graphesthesia

  4 Weeks

• Line Drawing

  4 Weeks

Other Outcomes (1)

• Adverse Events

  4 Weeks

Study Arms (2)

Spinal Treatment

EXPERIMENTAL

Participant receives High Velocity Low Amplitude Spinal Manipulation (HVLA) to the low back only from a doctor of chiropractic. Also receives focused palpation procedures to the low back paired with visual input of these procedures using a tablet computer. During a HVLA treatment, the study doctor will ask the participant to lie on their side on a treatment table. The doctor will make a quick and controlled push with their hand to slightly move joints in the low back. During palpation procedure, the doctor will touch several areas in the low back while asking questions about pain, tenderness and other sensations felt during this procedure. The participant will watch the doctor perform the palpation procedure in real time with a tablet computer.

Procedure: Spinal treatment

Foot Massage

ACTIVE COMPARATOR

The doctor of chiropractic will perform a massage of each foot while the participant lies face up in a relaxed position on a treatment table. The procedure will last approximately 10-20 minutes including massage to the toes, heel, sole, and top of each foot.

Procedure: Massage

Interventions

Spinal treatment PROCEDURE

This treatment will be applied to the low back region only. During a HVLA treatment, the study doctor will ask the participant to lie on their side on a treatment table. After carefully helping the participant into the proper position, the doctor will make a quick and controlled push with their hand to slightly move joints in the low back. During this procedure, the participant may feel and/or hear a popping sound. After treatment, the doctor may ask the participant to rest on the table for a few moments. During palpation procedure, the doctor will touch several areas in the low back while asking questions about pain, tenderness and other sensations felt during this procedure. The participant will watch the doctor perform the palpation procedure in real time with a tablet computer.

Also known as: High Velocity Low Amplitude Spinal Manipulation (HVLA), Chiropractic Adjustment, Focus Palpatory Procedure, Visual Input

Spinal Treatment

Massage PROCEDURE

The study doctor will perform a massage of each foot while the participant lies face up in a relaxed position on a treatment table. The procedure will last approximately 10-20 minutes including massage to the toes, heel, sole, and top of each foot.

Also known as: Foot Massage

Foot Massage

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65 Years
• Low Back Pain (LBP) meeting Quebec Task Force (QTF) Classifications 1-6
• Minimum LBP pain level on the 11-point NRS (Worst pain past 24 hours)
• LBP classified as chronic (onset more than 12 weeks previous)
• Written Informed Consent
• No plans to move out of the area in the next 6-8 weeks
• Transportation to come to the clinic on a regular basis

You may not qualify if:

• LBP meeting QTF Classifications 7-11
• Bone and joint pathology contraindicating spinal manipulation including: joint instability; recent spinal or rib fracture, or non-union; severe osteoporosis; spinal or paraspinal tumors; aortic aneurysm \> 5 cm; cauda equina syndrome
• Retention of legal advice related to this or a previous LBP episode or participants with active occupational or personal injuries cases
• Inability to read or verbally comprehend English
• Legally blind even with the aid of glasses and/or contact lenses
• Evidence of alcohol or drug dependence or abuse per self-report or as determined by history and examination
• Depression scores \> 29 (severe) on the Beck Depression Inventory-II
• Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study for the duration of the study period
• Co-morbidity requiring coincident clinical management, or prevent delivery of care, or interfering with ability to assess participant health status and/or treatment outcomes
• Co-morbidity requiring referral for serious or potentially serious health concerns
• Inflammatory disease of the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
• Uncontrolled hypertension
• Unable to safely tolerate study procedures
• Need for additional diagnostic procedures other than x-ray or urinalysis
• Pregnancy or seeking to become pregnant during active study phase

Sponsors & Collaborators

• Palmer College of Chiropractic: lead

Study Sites (1)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Chiropractic; Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Physical Therapy Modalities; Rehabilitation

Study Officials

• Christine M Goertz, DC, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chancellor for Research and Health Polciy

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)