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Low Back PainPRoGReSS-PSNCT01842737

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

A study testing Spinal treatment and Massage in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
Spinal treatment and Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Apr 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • Seeking or receiving compensation for any disability
  • Unable or unwilling to comply with study protocol
  • Extremity conditions preventing safe massage (e.g., injuries, infections)
  • Minimum pain level at each eligibility appointment
  • Recent tattoos or piercing in lumbar region (within past 6 months)
  • Peripheral neuropathy in the extremities due to safety concerns
  • Amputation of any extremity
  • Bleeding disorders due to safety concerns
  • Currently taking any opioid medication due to impact on pain perception
  • Unable to identify at least 3 out of 5 letters drawn on dominant hand during baseline examination due to somatosensory outcome measure (graphesthesia)
  • Fracture in back, hips or ribs past 8 weeks
  • History of spinal surgery or spinal injections to low back

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Palmer Center for Chiropractic Research

    Davenport, Iowa, 52803

Other trials in United States

About this study

Official title: PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Randomized Controlled Trial

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.

Read the detailed description

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. In this study, the researchers will:

  1. Measure the participant's back pain and function using research forms.
  2. Test the participant's ability to discern different touch sensations in the low back.
  3. Assess the participant's perceptions of the study procedures on research forms during the study and in a short interview at the end of the study.
Conditions
Low Back Pain
Being tested
Spinal treatment, Massage
Keywords
Low Back Pain, Chiropractic, Spinal Manipulation, Massage
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal treatmentProcedure or surgery

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

    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.

  • MassageProcedure or surgery

    Also called Foot Massage

    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.

Study groups in NCT01842737
Study groupRoleWhat they receive
Spinal TreatmentExperimentalParticipant 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.
Receives: Procedure: Spinal treatment
Foot MassageActive comparatorThe 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.
Receives: Procedure: Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 Weeks

Secondary outcomes (4)

  1. Roland Morris Disability Questionnaire

    The investigators will also use the participant self-report modified 23-item version of the Roland Morris Disability Questionnaire (RMDQ) to assess LBP related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one-page questionnaire related to low back pain disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, participant acceptance, and high face validity.

    Measured: 4 Weeks

  2. Two-Point Discrimination

    Participants will lie prone while a blinded assessor determines the threshold for two-point discrimination (TPD). TPD will be measured using a mechanical caliper (Lafayette two-point aesthesiometer, Lafayette IN, USA) with 1 mm precision. Testing will occur by completing two test runs (ascending and descending on each side of the spine) at 5 mm increments beginning with the calipers set at 20 mm and 90 mm respectively on each side of the low back. Participants will be asked to identify whether they perceive one or two points of touch. The single sided average of the ascending and descending TPD threshold will be considered the TPD distance for that side. Periodic out of sequence measurements (check trials) with out of sequence distance between points will reduce the chance of guessing. Two-point discrimination will be measured prior to treatment at study visit 1 and study visit 8.

    Measured: 4 Weeks

  3. Graphesthesia

    Graphesthesia - Participants will sit while a blinded assessor measures graphesthesia on the low back. Prior to measurement, participants will be shown a picture of the letters of the alphabet and the manner in which they will be drawn on the skin of their low back. The letters will be drawn with a monofilament aesthesiometer centered 5 cm lateral to the spinous process without crossing midline. Participants will be asked to identify 10 letters drawn on each side of the low back and error counts will be calculated. Graphesthesia will be measured prior to treatment at Study Visit 1 and at Study Visit 8.

    Measured: 4 Weeks

  4. Line Drawing

    Participants will be provided a sheet of paper with a pre-drawn outline of the middle thoracic region and gluteal folds shown from a posterior perspective, but the lower thoracic and lumbar region omitted. Participants will be asked to concentrate on their low back and draw its outline as they currently feel or sense it. The participant will be asked to draw the figure of their low back without touching their back and also to draw any vertebrae that they feel. Participants will be instructed to only draw what they feel rather than what they think their back looks like, and to avoid drawing any part of their back that they cannot sense or feel. Line drawings will be collected prior to treatment at study visits 1 and 8.

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842737
Sponsor's protocol ID
PRoGReSS-PS
Acronym
PRoGReSS-PS
Status last verified
Mar 2017
First submitted
23 Apr 2013
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Feasibility/pilot study

Questions about this trial

What is this clinical trial studying?

A study testing Spinal treatment and Massage in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Back Pain Visual Analogue Scale (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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