Low Back PainNCT02757378
Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
A study testing Neuroplasticity Explanation (Experimental) in people with Low Back Pain, run by Kevin Farrell at 5 sites in United States.
Trial summary
This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Neuroplasticity Explanation (Experimental)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2015to Sep 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18
- Presenting at Physical Therapy with a primary complaint of Low Back Pain
- Low Back Pain being present for 6 months or more
- Fluent in English and willing to participate in the study.
Who cannot join
- Medical precautions to the use of manual therapy (metal, skin lesions, etc.)
- Prior spine surgery
- Unable to lay prone for the treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rock Valley Physical Therapy
Davenport, Iowa, 52806
Genesis Physical Therapy and Sports Medicine
Davenport, Iowa, 52807
Rock Valley Physical Therapy
Moline, Illinois, 61265
Rock Valley Physical Therapy
Silvis, Illinois, 61282-4700
Edward Health & Fitness Center & Spa at Seven Bridges
Woodridge, Illinois, 60517
About this study
Official title: A Randomized Controlled Trial of Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.
Read the detailed description
Traditional treatment provided by physical therapists to patients with chronic low back pain focuses on the biomechanical or anatomical impact to local tissues. Recent research has shown that treatment effects may be more related to the understanding of the structural and functional changes in the brain of someone suffering from chronic low back pain. This research implicates that the patients understanding and interpretation of input to the brain may change the patient's perceived representation and interpretation of output of pain within the brain.
- Conditions
- Low Back Pain
- Being tested
- Neuroplasticity Explanation (Experimental), Biomechanical Explanation (Control)
- Keywords
- Pain, Brain, Plasticity, Education, Manual Therapy, Straight Leg Raise, Remapping
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroplasticity Explanation (Experimental)Procedure or surgery
Patients were given an explanation of how the brain uses the information from a manual therapy technique to help it remain sharp in identifying where this input is coming from.
Biomechanical Explanation (Control)Procedure or surgery
Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.
| Study group | Role | What they receive |
|---|---|---|
| Neuroplasticity Education Group | Experimental | Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique Receives: Procedure: Neuroplasticity Explanation (Experimental) |
| Biomechanical Education Group | Active comparator | Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique Receives: Procedure: Biomechanical Explanation (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain rating change
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of the patient's pain in low back on a numeric pain rating scale of 0 to 10
Measured: Within a single, one hour session
Leg pain rating
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement, level of patient's leg pain on a numeric pain rating scale of 0 to 10.
Measured: Within a single, one hour session
Active trunk forward flexion
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of distance from longest finger to the floor when patient bends forward (in cm).
Measured: Within a single, one hour session
Straight Leg Raise
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of angle to which the patient's most affected leg can be lifted (measured in degrees using an inclinometer).
Measured: Within a single, one hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Farrell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin Farrell, St. Ambrose University
- Investigators
- Adriaan Louw, PT, PhD, Principal investigator, International Spine Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757378
- Sponsor's protocol ID
- StAmbroseU
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02757378
- Acronym / sponsor ID
- StAmbroseU
- Conditions
- Low Back Pain
- Keywords
- Pain, Brain, Plasticity, Education, Manual Therapy, Straight Leg Raise, Remapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kevin FarrellUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.
Detailed description
Traditional treatment provided by physical therapists to patients with chronic low back pain focuses on the biomechanical or anatomical impact to local tissues. Recent research has shown that treatment effects may be more related to the understanding of the structural and functional changes in the brain of someone suffering from chronic low back pain. This research implicates that the patients understanding and interpretation of input to the brain may change the patient's perceived representation and interpretation of output of pain within the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroplasticity Education Group | Experimental | Procedure: Neuroplasticity Explanation (Experimental)Patients who receive manual physical therapy treatment with a neuroplasticity explanation of the basis for the technique |
| Biomechanical Education Group | Active comparator | Procedure: Biomechanical Explanation (Control)Patients who receive manual physical therapy treatment with a traditional, biomechanical explanation of the basis for the technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over the age of 18
- Presenting at Physical Therapy with a primary complaint of Low Back Pain
- Low Back Pain being present for 6 months or more
- Fluent in English and willing to participate in the study.
Key exclusion criteria (3 listed)
- Medical precautions to the use of manual therapy (metal, skin lesions, etc.)
- Prior spine surgery
- Unable to lay prone for the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroplasticity Explanation (Experimental)Patients were given an explanation of how the brain uses the information from a manual therapy technique to help it remain sharp in identifying where this input is coming from. | Procedure or surgery | Neuroplasticity Education Group |
| Biomechanical Explanation (Control)Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back. | Procedure or surgery | Biomechanical Education Group |
Primary outcome
Low back pain rating change
Time frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of the patient's pain in low back on a numeric pain rating scale of 0 to 10
Leg pain rating
Time frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement, level of patient's leg pain on a numeric pain rating scale of 0 to 10.
Active trunk forward flexion
Time frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of distance from longest finger to the floor when patient bends forward (in cm).
Straight Leg Raise
Time frame: Within a single, one hour session
Change, measured within a single, one hour session, of baseline measurements taken, followed immediately by the education / treatment, followed immediately by post-education / treatment measurement of angle to which the patient's most affected leg can be lifted (measured in degrees using an inclinometer).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan Louw, PT, PhD principal investigator
International Spine Pain Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroplasticity Explanation (Experimental) in people with Low Back Pain, run by Kevin Farrell at 5 sites 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 4 inclusion and 3 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Low back pain rating change (time frame: Within a single, one hour session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2016.